The Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Depression in PD (PD-D-taVNS)
25 juni 2026 uppdaterad av: The First Affiliated Hospital with Nanjing Medical University
Transcutaneous Auricular Vagus Nerve Stimulation Alleviates Depressive Symptoms in Patients With Parkinson's Disease and Depression During Verbal Fluency Tasks
This study is a double blind comparative study examining the effectiveness of the transcutaneous auricular vagus nerve stimulation treatment on Parkinson's disease patients with depression.
The investigators hypothesize that taVNS will improve depression and cortical activity in Parkinson's disease patients with depression.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Detaljerad beskrivning
Participants in the Experimental group underwent fourteen consecutive daily sessions of transcutaneous auricular vagus nerve stimulation (taVNS, twice daily, 30 minutes each time) , whereas participants in the sham stimulation group underwent fourteen consecutive daily sessions of sham taVNS.
Assessments of depression symptoms, motor symptoms were performed three times: at baseline, one day post intervention and 2 weeks post intervention.
The cortical activity (using Functional near-infrared spectroscopy) were assessed at baseline, one day post intervention.
Studietyp
Interventionell
Inskrivning (Beräknad)
30
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Kezhong Zhang
- Telefonnummer: 13770840575
- E-post: kezhong_zhang1969@126.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
This study recruited right-handed subjects from the Department of Neurology, Huai'an Second People's Hospital. The inclusion criteria for patients with PD and depression were as follows: diagnosis of idiopathic Parkinson's disease based on the clinical diagnostic criteria of the Movement Disorder Society; diagnosis of depressive disorder in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with a Hamilton Depression Rating Scale (HAMD) score ≥ 8; stable medication regimens for Parkinson's disease for at least one month prior to enrollment; aged 40 to 80 years; and voluntary participation with written informed consent. In addition, age- and gender-matched non-depressed PD patients and healthy controls were enrolled to further compare brain functional characteristics among different groups.
Exclusion Criteria:
presence of cognitive impairment defined as a Montreal Cognitive Assessment (MoCA) score < 23; ongoing use of antidepressant medications; presence of contraindications related to transcutaneous auricular vagus nerve stimulation (taVNS); receipt of vagus nerve stimulation (VNS) treatment within the past month; and comorbid severe neurological, renal, cardiovascular or hepatic diseases.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: real Transcutaneous auricular vagus nerve stimulation
Two modified dot-like electrodes delivered the stimulation to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve.Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min.Every PD patient received stimulation twice daily ,30 minutes each time, for 14 consecutive days.
The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.
|
Active Transcutaneous auricular vagus nerve stimulation:Two modified dot-like electrodes delivered the stimulation to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve.Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min.Every PD patient received stimulation twice daily ,30 minutes each time, for 14 consecutive days.
The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.Sham Transcutaneous auricular vagus nerve stimulation:Two modified dot-like electrodes delivered the stimulation to the cymba conchae of left ear in the vicinity of the auricular branch vagus nerve.
The stimulation paradigm was identical to that of the real stimulation group.
The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.
|
|
Sham Comparator: Sham Transcutaneous auricular vagus nerve stimulation
Two modified dot-like electrodes delivered the stimulation to the left earlobe.
Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min.
Every PD patient received stimulation twice daily , 30 minutes each time, for 14 consecutive days.
The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.
|
Two modified dot-like electrodes delivered the stimulation to the left earlobe.
Stimulation parameters: frequency = 20/4 Hz; pulse width = 200 μs; 20 Hz lasting 7 seconds, alternated with 4 Hz lasting 3 seconds#repeat until 30 min.
Every PD patient received stimulation twice daily , 30 minutes each time, for 14 consecutive days.
The stimulation intensity was set as the maximum value the patient could tolerate without causing pain.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
change of Hamilton Depression Scale Score
Tidsram: Assessed at baseline, one day post intervention,2 weeks post intervention
|
Hamilton Depression Scale (HAM-D score), which was used for assessing the degree of Depression.The differences in HAMD score before and after treatment can be used to evaluate the effect of taVNS treatment
|
Assessed at baseline, one day post intervention,2 weeks post intervention
|
|
change of Hamilton Depression Scale Score Hamilton Anxiety Scale (HAM-D score), which was used for assessing the degree of anxiety.The differences in HAMD score before and after treatment can be used to evaluate the effect of taVNS treatment
Tidsram: Assessed at baseline, one day post intervention#2 weeks post intervention
|
Assessed at baseline, one day post intervention#2 weeks post intervention
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Studierektor: Kezhong Zhang, China, Jiang Su the First Affiliated Hospital of Nanjing Medical University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
1 augusti 2026
Avslutad studie (Beräknad)
1 augusti 2026
Studieregistreringsdatum
Först inskickad
25 juni 2026
Först inskickad som uppfyllde QC-kriterierna
25 juni 2026
Första postat (Faktisk)
1 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
25 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026-06
- The First Affiliated Hospital (Annan identifierare: The First Affiliated Hospital with Nanjing Medical University)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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