Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease (tVNS_PD)
2026年8月4日 更新者：Alicia Martínez Rodríguez、Universidade da Coruña
Effects of Transcutaneous Stimulation of the Auricular Branch of the Vagus Nerve in Parkinson´s Disease
This study aims to determine whether electrical stimulation of the ear, when combined with physical and speech therapy, can improve symptoms in subjects diagnosed with Parkinson´s disease, by comparing two different application sites.
Each subject will undergo an initial in-person screening and provide consent before participating in the study.
The main questions to answer are:
- Does transcutaneous electrical nerve stimulation (tVNS) in the ear paired with physical and speech therapy improve speech and voice-related problems, airway protection, salivation, and swallowing?
- Does tVNS paired with physical and speech therapy improve tremor, walking speed, and balance in people with PD?
- Does tVNS paired with physical and speech therapy improve heart rate and heart rate variability in people with PD?
- Do its effects persist at 8 weeks?
Participants will:
Attend 12 rehabilitation sessions over 4 weeks (three per week). During each session, participants received either active or sham tVNS, accompanied by speech therapy (once per week), physical therapy (once per week), or conducted alone (once per week).
Undergo speech, voice, swallowing, respiratory, gait, balance, tremor, heart rate variability, and cognitive testing, as well as questionnaires regarding the quality of life, before and after treatment.
Return for a follow-up visit eight weeks after therapy to check how long the effects last.
調査の概要
状態
積極的、募集していない
詳細な説明
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease. Most people with PD will experience dysfunction of the autonomic nervous system (ANS), although the severity of this dysfunction can vary widely, affecting both physical and mental well-being. Symptoms are typically classified as motor or non-motor. Prominent motor symptoms of PD include bradykinesia, rigidity, tremor, and abnormalities in gait, balance, and posture. These symptoms are associated with falls and have a very negative impact on quality of life. In addition, impaired fine motor skills, combined with respiratory and other problems, significantly affect voice, speech, and swallowing, as well as other non-motor disorders, such as neuropsychiatric, sleep, sensory, and digestive disorders.
This study is a double-blind, randomized, controlled trial designed to evaluate the efficacy of transcutaneous auricular vagus nerve stimulation on the motor and non-motor effects of Parkinson´s Disease (PD). Investigators will recruit up to 46 patients. The volunteers will be randomized by sex and the Hoehn and Yahr stage. Clinical information and, specifically, Unified Parkinson's Disease Rating Scale (UPDRS) -III (section III) will be assessed initially.
The primary variable of the study will be voice variables, such as volume, jitter, and shimmer. The remaining dependent variables will be other voice and acustic measures; the presence and severity of dysphagia; the presence and severity of xerostomia and sialorrhea; swallowing efficiency, peak cough flow; the level of tremor; the severity of gait dysfunction; balance; cognitive ability regarding concentration and response inhibition; heart rate and heart rate variability; quality of life in PD; adverse effects; and the degree of effectiveness of blinding.
Over the course of 4 weeks, participants will receive 30-minute stimulation sessions three times weekly, along with physiotherapy and speech therapy once per week. One group will be assigned to stimulation in the cymba concha (where the vagus nerve is placed) and the other (sham) in the earlobe.
Data collection will occur at baseline (T0), post-intervention (T1- 4 weeks), and 8 weeks after finishing the intervention (T2), except for the intensity required to administer electrical stimulation and adverse effects, which will be studied during the whole intervention. Tolerance will be assessed on day 1 of stimulation and on day 12 (4 weeks). Statistical analyses will employ mixed-model approaches to evaluate changes in outcome measures over time and between interventions.
研究の種類
介入
入学 (推定)
46
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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A Coruña、スペイン、15008
- Association of Parkinson´s Disease Galicia- Coruña
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Being a member of the Association or be interested in joining;
- Idiopathic PD diagnosis, stages 2-3 according to the Hoehn & Yahr scale; confirmed by neurologist
- Ability to walk independently for at least 1 minute ant turn 180° without assistance;
- Exhibiting symptoms of hypokinetic dysarthria;
- On stable dopaminergic therapy for at least 1 month prior to the experiment
Exclusion Criteria:
- Any contraindication for taVNS (e.g., ear lesions, pacemakers, defibrillators, or other electronic devices)
- Previous vagotomy or previous application of electrical stimulation to the ear or brain, or treatment with high-intensity focused ultrasound (HIFU)
- Voice or speech disorders caused by other medical conditions
- MoCA score below 21
- Psychotic symptoms or hallucinations; a diagnosis of psychiatric illness
- Systolic blood pressure above 160 mm Hg, and diastolic blood pressure above 100 mm Hg
- Inability to attend sessions;
- Concomitant neurological, orthopaedic, cardiac, respiratory or active medical/oncological condition that would affect participation
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Active tVNS paired with conventional Speech Therapy and Physical Therapy
Participants in this arm will receive transcutaneous electrical stimulation applied to the concha of the left ear for 30 minutes, three times a week, over a 4-week period.
This location is known to be innervated by the auricular branch of the vagus nerve.
In addition, a speech therapy session and a physical therapy session will be added once a week each, while receiving the electrical stimulation.
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The tVNS will be performed at 200 microseconds, with frequencies ranging from 20 to 200 Hz (30 seconds/30 seconds) for 30 minutes, in the area innervated by the auricular branch of the vagus nerve (cymba concha and concha).
The individually titrated intensity will be set above the sensory threshold (intense tingling sensation) but below the level of discomfort.
他の名前：
Physical therapy delivered to both groups consists of exercises aimed at posture alignment and body coordination, static and dynamic balance improvement, and gait quality.
It will be delivered once a week, during a session of electrical stimulation.
It will focus on the orofacial muscles, the acquisition of a diaphragmatic-abdominal breathing pattern that integrates breathing with vocal production, voice training with exercises that enhance vocal quality and prosody, articulation exercises to improve speech clarity, and swallowing training.
It will be administered once a week, during one of the three electrical stimulation sessions.
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偽コンパレータ：Sham tVNS paired with Speech Therapy and Physical Therapy
Participants in this arm will receive the same transcutaneous electrical stimulation as the active group, but applied to the earlobe, a site not innervated by the vagus nerve.
The procedure, the appearance of the device, and the parameters are identical to those of the active condition to maintain participant blinding.
In addition, a speech therapy session and a physical therapy session will be added once a week each, while receiving the electrical stimulation.
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Physical therapy delivered to both groups consists of exercises aimed at posture alignment and body coordination, static and dynamic balance improvement, and gait quality.
It will be delivered once a week, during a session of electrical stimulation.
It will focus on the orofacial muscles, the acquisition of a diaphragmatic-abdominal breathing pattern that integrates breathing with vocal production, voice training with exercises that enhance vocal quality and prosody, articulation exercises to improve speech clarity, and swallowing training.
It will be administered once a week, during one of the three electrical stimulation sessions.
The sham- tVNS will be performed at 200 microseconds, with frequencies ranging from 20 to 200 Hz (30 seconds/30 seconds) for 30 minutes, with electrodes placed on the earlobe, which lacks vagus nerve innervation.
The individually titrated intensity will be set above the sensory threshold (intense tingling sensation) but below the level of discomfort.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Voice intensity
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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The PRAAT software will be used to test the voice twice, when sustaining till 10 seconds the vowel "a" and when reading a text at their usual volume.
The intensity (voice volume, measured in decibels) will be recorded.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Voice- Jitter
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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It is derived from the sustaining till 10 seconds the vowel "a".
Then, PRAAT software will be used to test the voice, discarding the beginning and the end.
The Jitter is defined as the variation in frequency from cycle to cycle, a measure of vocal instability, expressed as a percentage.
The higher the percentage, the more irregularities the voice will have.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Voice- Shimmer
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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It is derived from the sustaining till 10 seconds the vowel "a".
Then, PRAAT software will be used to test the voice, discarding the beginning and the end.
The Shimmer refers to the variation in the amplitude of the sound wave.
It is a measure of vocal instability, expressed as a percentage.
The higher the percentage, the more irregularities the voice will have.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Voice fundamental frequency (F0)
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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The PRAAT software will be used to test the voice twice, when sustaining till 10 seconds the vowel "a" and when reading a text at their usual volume.
The fundamental frequency (F0) is the oscillation originating from the vocal folds.
It will be recorded in Hz.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Harmonic to Noise Ratio (HNR)
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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The PRAAT software will be used to test the voice twice, when sustaining till 10 seconds the vowel "a" and when reading a text at their usual volume.
The Harmonic to Noise Ratio (HNR), a measure of the ratio between the periodic and non-periodic components that make up a segment of spoken voice, will be recorded.
This ratio reflects the efficiency of sound production; that is, the greater the amount of airflow converted from the lungs into vocal cord vibration energy, the higher the HNR will be.
A low HNR indicates a weak voice and dysphonia.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Maximum phonation time (MPT)
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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The participant will be asked to sustain the vowel /a/ for as long as possible after a deep inhalation.
It will be repeated three times, and the best value will be recorded.
The maximum phonation time (MPT) will be measured in seconds.
The same procedure will be taken for the /s/.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Maximum expiratory time during sustained /s/
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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The participant will be asked to sustain the /s/ sound for as long as possible after a deep inhalation.
It will be repeated three times, and the best value in seconds will be recorded.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Index s/a
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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The index s/a is used to compare respiratory with laryngeal function, based on the assumption that the two are similar, so the ratio should be 1.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Diadihokinetic rates (DDK)
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Diadochokinesis measures the ability to perform rapid, alternating muscle movements in a repetitive manner.
It assesses the rate and regularity of consonant-vowel repetitions /pa-ta-ka/.
The individual is instructed to repeat the syllables /pa-ta-ka/ as quickly and accurately as possible for 10 seconds.
The higher the value, the better.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Self-perceived handicap associated with dysphonia: Voice Handicap Index (VHI-10)
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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The Voice Handicap Index- 10 (VHI-10) is a valid instrument for assessing self-perceived disability associated with dysphonia.
It consists of 10 items designed to evaluate patients´ perception of the impact of voice disorders on their quality of life.
Each item contains specific questions related to the functional, emotional, and physical aspects of the voice.
The patient must answer on a Likert-type scale with options ranging from 0 (never) to 4 (always).
The total score is obtained by summing the responses, with a range of 0 to 40, where higher scores indicate a greater degree of vocal impairment.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Salivation
時間枠：Baseline (T0), post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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To measure salivation, a dry cloth will be placed in the mouth and weighed after 2 minutes without swallowing to estimate the volume of saliva produced.
Changes in weight will be recorded.
A higher final weight-and thus a greater difference-indicates increased saliva production.
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Baseline (T0), post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Swallowing- dysphagia
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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It will be measured by Repetitive Saliva Swallowing Test (RSST), where the patient is asked to swallow saliva as many times as possible for 30 s, while deglutition is counted through palpation of the larynx.
A value below 3 swallows has been found to be pathological.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Cookie Swallow Test
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Time will be measured (velocity), swallow security and efficacy, checking for any residue after swallowing.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Timed Water Swallow Test (TWST)
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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The time taken to consume 150 mL of bottled water and the swallowing capacity (mL/s) will be measured, as well as efficacy and safety.
We will assess whether there has been a reduction in swallowing time, indicating an improvement in swallowing ability.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Sialorrhea
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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The Sialorrhea Clinical Scale for Parkinson´s Disease assesses sialorrhea; drooling severity, drooling frequency and impact on daily life,.
It is a Likert-type 7-item.
Each item is ranked on a scale of 0 to 3, with a maximum score of 21.
Higher scores correspond to greater disability.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Cough Peak Flow (CPF)
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow
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It measures the maximum amount of air exhaled by coughing after taking a deep breath, using the best of three attempts.
The A CPF above 270 L/min is associated with an effective cough and good ability to expel secretions.
In contrast, a CPF below 160 L/min is considered an ineffective cough, with a higher likelihood of respiratory complications.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow
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Cognitive ability to concentrate and inhibit responses- Flanker test
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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The Flanker test is designed to assess selective attention and inhibitory function, indicating the direction of a central row, flanked by non-target stimuli, which can be congruent (matching the target) or incongruent (opposite to the target).
It will be done using an app (C2 Flanker Task) on a tablet with both thumbs at the same time.
The reaction time is measured, with higher times indicating less ability to suppress responses to distracting stimuli while focusing on a target stimulus.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Hand tremor
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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The tremor in left hand will be measured with the app (G-Sensor Logger) for a minute, using a mobile phone secured to the hand.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Static balance- distances
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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For static balance, a baropodometric platform will be used, and the centre of pressure area (mm), the ellipse area (mm2), and the displacements in the axes of space (mm) will be measured, with eyes open, twice.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Static balance- velocity
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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For static balance, a baropodometric platform will be used, and the speed (mm/s) of displacements along the axes of space will be measured, with eyes open, twice.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Dynamic balance and functional mobility
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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The Timed Up and Go test (TUG) represents a measure of global ambulation skills.
The patient sits back in a standard chair and, on the command "go", the patient rises, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down.
Time for each attempt is recorded.
The best result from 3 attempts will be selected.
The longer it takes to complete, the worse the situation becomes, with 12 seconds being the cutoff point for the risk of falling.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Heart Rate Variability (HRV)- frequency domain
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Heart Rate Variability (HRV) using Kubios app and H10 polar heart rate monitor chest strap in periods of 5 minutes: Frequency domain; ratio LF/HF power will be calculated along with normalised LF/HF where baseline values will set to 1; Low frequency (LF, referred to HRV frequency band 0.04-0.15 Hz); High frequency (HF = HRV frequency band 0.15-0.4 Hz); absolute powers of LF, and HF bands (ms2); normalized power (powers of LF and HF bands in normalised units, %) |
Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Heart Rate Variability (HRV)- time domain
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Heart Rate Variability (HRV) using Kubios app and H10 polar heart rate monitor chest strap in periods of 5 minutes: Time domain: RR (mean values of RR intervals in ms) ; SDNN (Standard deviation of RR intervals); RMSSD (Root mean square of successive RR interval differences, in ms) |
Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Heart Rate Variability (HRV)- Global measures
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Heart Rate Variability (HRV) using Kubios app and H10 polar heart rate monitor chest strap in periods of 5 minutes: Global measures: Stress Index (SI), square root of Baevsky's stress index; Parasympathetic nervous system (PNS) index; Sympathetic nervous system (SNS) index |
Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Quality of life in Parkinson´s Disease (PDQ-8)
時間枠：Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Quality of life will be assessed using the Parkinson's Disease Questionnaire-8 (PDQ-8), which measures mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort.
Each item is scored on a 0 (= never) to 4 (= always or cannot do at all) range, so the lowest and highest possible scores are 0 and 32, respectively.
Greater scores indicate poorer quality of life.
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Baseline (T0), Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Effectiveness of blinding
時間枠：Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Participants will be asked what stimulation they think they have just received, active or placebo (or what is their best guess) and why.
Comparison of participants´perceptions with the actual assignment, James Bang Index.
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Post-intervention (T1, 4 weeks), along with an 8-week post-trial follow-up (T2)
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Adverse effects
時間枠：All days of intervention (up to 4 weeks)
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A questionnaire will be used to test the presence, severity, persistence and causality of ear pain, headache, tingling, itching, redness, irritation, pressure, dizziness, nausea, vertigo, fatigue, vertigo, palpitations, tinnitus, unpleasant feeling, and/or other effects.
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All days of intervention (up to 4 weeks)
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Tolerance to auricular TENS
時間枠：Baseline and week-4
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The level of tolerance of the entire stimulation (by electrical stimulation, by electrodes, or by both) will be measured on a VAS scale from 0 (no discomfort at all) to 10 (the discomfort would have prevented me from finishing the session).
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Baseline and week-4
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Amplitude of electrical stimulation
時間枠：All days of intervention (up to 4 weeks)
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Amplitude used in the auricular electrical stimulation in mA, as well as the sensory and discomfort threshold.
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All days of intervention (up to 4 weeks)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Alicia Martínez-Rodríguez, Lecrurer、Universidade da Coruña
- 主任研究者：Olalla Bello, Lecurer、Universidade da Coruña
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月25日
一次修了 (推定)
2026年9月1日
研究の完了 (推定)
2026年11月1日
試験登録日
最初に提出
2026年4月23日
QC基準を満たした最初の提出物
2026年5月11日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月7日
QC基準を満たした最後の更新が送信されました
2026年8月4日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2025/295_II
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
The IPD that underlie the results included in the publication will be shared on Zenodo, with a description of the codes and the information needed to understand them.
IPD 共有時間枠
Beginning 1 year after publication and with no ending while Zenodo keep the data
IPD 共有アクセス基準
The results will be included in a document that will be shared on Zenodo with all investigators interested in them via direct access.
IPD 共有サポート情報タイプ
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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