STN-tTIS With Different Intervention Intervals Versus Standard Medical Treatment for Parkinson's Disease
STN-targeted Temporal Interference Stimulation With Different Intervention Intervals Versus Standard Medical Treatment for Parkinson's Disease: A Multicenter, Randomized, Controlled Trial
The goal of this clinical trial is to compare the efficacy and safety of different Intervention Intervals of subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) in patients with Parkinson disease.
Previous studies suggest that STN-tTIS may improve motor symptoms in people with Parkinson disease. However, most previous studies evaluated only one stimulation session. It remains unclear how often STN-tTIS should be administered during a repeated treatment course and whether shorter intervention intervals stimulation produces greater or longer-lasting improvement without increasing adverse events.
The main questions this study aims to answer are:
- Does STN-tTIS administered five times weekly improve motor symptoms more than standard medication treatment alone at the end of the 2-week treatment period?
- Do once-weekly, twice-weekly, and five-times-weekly STN-tTIS produce different changes in motor symptoms?
- Does the STN-tTIS intervention intervals influence how long its effects persist after treatment?
- Do the different intervention intervals have different effects on non-motor symptoms, quality of life, cognitive function, and safety?
Participants will be randomly assigned to receive STN-tTIS once weekly, twice weekly, or five times weekly for 2 weeks, or to continue standard antiparkinsonian medication without additional stimulation. All participants will maintain a stable medication regimen during the study. Their motor and non-motor symptoms will be assessed during the treatment period and during a subsequent 2-week follow-up period.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
Parkinson disease (PD) is a progressive neurodegenerative disorder characterized by both motor and non-motor symptoms that substantially impair quality of life. Although pharmacological therapy remains the standard treatment, long-term medication use is frequently associated with motor fluctuations and treatment-related complications. Transcranial temporal interference stimulation (tTIS) is a novel noninvasive neuromodulation technique capable of selectively modulating deep brain structures without surgery. Previous pilot studies have demonstrated that subthalamic nucleus-targeted tTIS (STN-tTIS) may improve motor symptoms in patients with PD. However, existing studies have primarily evaluated the immediate effects of single-session stimulation, and the optimal intervention interval for repeated STN-tTIS has not yet been established.
The objective of this multicenter clinical trial is to evaluate whether different intervention intervals, defined as once-weekly, twice-weekly, and five-times-weekly STN-tTIS administration, result in different therapeutic effects in patients with PD and to compare their efficacy and safety. The study will also investigate whether the intervention interval influences the durability of clinical improvement following completion of the intervention.
Approximately 60 participants with PD will be enrolled and randomly assigned to one of three active STN-tTIS treatment groups with different intervention intervals or to a control group receiving standard medical therapy alone. All participants will continue a stable antiparkinsonian medication regimen throughout the study. The treatment period will last 2 weeks, followed by a 2-week follow-up period. Clinical efficacy will be evaluated primarily by changes in motor symptoms, while additional assessments will evaluate non-motor symptoms, sleep, quality of life, cognitive function, and safety. This study will provide information regarding the influence of intervention intervals on the efficacy and safety of repeated STN-tTIS in patients with Parkinson disease and may help inform future treatment strategies.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Chencheng Zhang, MD, PHD
- Puhelinnumero: 13381827024
- Sähköposti: i@cchang.org
Opiskelupaikat
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kiina, 200025
- Rekrytointi
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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Ottaa yhteyttä:
- Chencheng Zhang, MD, PHD
- Puhelinnumero: 13381827024
- Sähköposti: i@cchang.org
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- 1.Aged 50-85 years, male or female.
- 2.Diagnosed with idiopathic Parkinson disease (PD) in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Parkinson's Disease (4th Edition), with a confirmed diagnosis for at least 6 months and a stable condition, defined as no significant deterioration or major medication adjustment within the past month.
- 3.Receiving stable doses of antiparkinsonian medication (e.g., levodopa or dopamine agonists) and willing to maintain the medication regimen during the study.
- 4.Hoehn and Yahr stage 1-3 in the medication ON state.
- 5.Baseline MDS-UPDRS Part III total score ≥20 in the medication ON state.
- 6.No history of non-invasive neuromodulation therapy, or discontinuation of such therapy for at least 3 months before enrollment if previously received.
- 7.Normal cognitive function (MoCA score ≥24) and able to cooperate with tTIS intervention, clinical scale assessments, and basic smartphone- and smartwatch-assisted home-based motor self-assessments.
- 8.Able and willing to provide written informed consent and complete all required study procedures and follow-up assessments.
Exclusion Criteria:
- 1.Other neurological disorders that may affect motor or cognitive function.
- 2.Contraindications to magnetic resonance imaging (MRI), such as claustrophobia.
- 3.History of taking antipsychotics, antidepressants, or other medications affecting dopamine levels.
- 4.Psychiatric disorders (e.g., depression or schizophrenia), substance abuse, or alcohol dependence.
- 5.Implanted medical devices (e.g., pacemaker or defibrillator), metal implants in the cranium or spine, a personal or family history of epilepsy, or severe skull defects.
- 6.Previous deep brain stimulation (DBS) or other intracranial implantation surgery, or participation in another Parkinson disease clinical trial within the past 3 months.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Kokeellinen: STN-tTIS Once Weekly
Participants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) once weekly for 2 weeks in addition to stable antiparkinsonian medication.
|
Participants receive subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) once weekly for 2 weeks.
Each stimulation session lasts 20 minutes.
Two high-frequency alternating currents at 2000 Hz and 2130 Hz are delivered through two pairs of scalp electrodes, generating a 130-Hz temporal interference envelope targeting the subthalamic nucleus.
Stable antiparkinsonian medication is maintained throughout the intervention period.
Muut nimet:
Participants continue their stable antiparkinsonian medication regimen throughout the 2-week study intervention period.
No additional STN-tTIS is administered.
|
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Kokeellinen: STN-tTIS Twice Weekly
Participants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) twice weekly for 2 weeks in addition to stable antiparkinsonian medication.
|
Participants continue their stable antiparkinsonian medication regimen throughout the 2-week study intervention period.
No additional STN-tTIS is administered.
Participants receive subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) twice weekly for 2 weeks.
Each stimulation session lasts 20 minutes.
Two high-frequency alternating currents at 2000 Hz and 2130 Hz are delivered through two pairs of scalp electrodes, generating a 130-Hz temporal interference envelope targeting the subthalamic nucleus.
Stable antiparkinsonian medication is maintained throughout the intervention period.
Muut nimet:
|
|
Kokeellinen: STN-tTIS Five Times Weekly
Participants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) five times weekly for 2 weeks in addition to stable antiparkinsonian medication.
|
Participants continue their stable antiparkinsonian medication regimen throughout the 2-week study intervention period.
No additional STN-tTIS is administered.
Participants receive subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) five times weekly for 2 weeks.
Each stimulation session lasts 20 minutes.
Two high-frequency alternating currents at 2000 Hz and 2130 Hz are delivered through two pairs of scalp electrodes, generating a 130-Hz temporal interference envelope targeting the subthalamic nucleus.
Stable antiparkinsonian medication is maintained throughout the intervention period.
Muut nimet:
|
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Active Comparator: Standard Medical Therapy Alone
Participants continue their stable antiparkinsonian medication regimen for 2 weeks without additional STN-tTIS.
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Participants continue their stable antiparkinsonian medication regimen throughout the 2-week study intervention period.
No additional STN-tTIS is administered.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change From Baseline in MDS-UPDRS Part III Total Score at the End of the Intervention Period
Aikaikkuna: Baseline to Day 12
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The Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) is used to assess the severity of motor symptoms in Parkinson disease.
The total score ranges from 0 to 132, with higher scores indicating greater motor impairment.
The primary outcome is the change in MDS-UPDRS Part III total score from baseline to Day 12, corresponding to the end of the 2-week intervention period.
Assessments are performed during the ON medication state.
A greater reduction from baseline indicates greater improvement in motor symptoms.
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Baseline to Day 12
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change From Baseline in MDS-UPDRS Part I Score
Aikaikkuna: Baseline to Day 12 and Day 27
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The Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part I (MDS-UPDRS Part I) assesses non-motor aspects of experiences of daily living in Parkinson disease.
Scores will be assessed at baseline, Day 12, and Day 27.
Higher scores indicate greater impairment.
Changes from baseline will be compared among the study groups.
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Baseline to Day 12 and Day 27
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Change From Baseline in MDS-UPDRS Part II Score
Aikaikkuna: Baseline to Day 12 and Day 27
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The MDS-UPDRS Part II assesses motor aspects of experiences of daily living in Parkinson disease.
Scores will be assessed at baseline, Day 12, and Day 27.
Higher scores indicate greater impairment.
Changes from baseline will be compared among the study groups.
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Baseline to Day 12 and Day 27
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Change From Baseline in MDS-UPDRS Part IV Score
Aikaikkuna: Baseline to Day 12 and Day 27
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The MDS-UPDRS Part IV assesses motor complications associated with Parkinson disease, including motor fluctuations and dyskinesias.
Scores will be assessed at baseline, Day 12, and Day 27.
Higher scores indicate greater motor complications.
Changes from baseline will be compared among the study groups
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Baseline to Day 12 and Day 27
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Change From Baseline in Non-Motor Symptoms Scale (NMSS) Score
Aikaikkuna: Baseline to Day 12 and Day 27
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The Non-Motor Symptoms Scale (NMSS) is used to assess the severity and frequency of non-motor symptoms associated with Parkinson disease.
Higher scores indicate a greater burden of non-motor symptoms.
NMSS scores will be assessed at baseline, Day 12, and Day 27, and changes from baseline will be compared among the study groups.
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Baseline to Day 12 and Day 27
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Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Score
Aikaikkuna: Baseline to Day 12 and Day 27
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The Parkinson's Disease Questionnaire-39 (PDQ-39) is a patient-reported measure of Parkinson disease-related quality of life.
Higher scores indicate poorer health-related quality of life.
PDQ-39 scores will be assessed at baseline, Day 12, and Day 27, and changes from baseline will be compared among the study groups.
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Baseline to Day 12 and Day 27
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Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) Score
Aikaikkuna: Baseline to Day 12 and Day 27
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The Parkinson's Disease Sleep Scale (PDSS) is used to assess sleep-related symptoms in patients with Parkinson disease.
PDSS scores will be assessed at baseline, Day 12, and Day 27, and changes from baseline will be compared among the study groups.
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Baseline to Day 12 and Day 27
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in Remotely Assessed MDS-UPDRS Part III Score
Aikaikkuna: Day 1 to Day 27
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Motor symptoms will be assessed remotely using the MDS-UPDRS Part III at prespecified time points during the intervention and follow-up periods.
Longitudinal changes in remotely assessed motor scores will be evaluated to characterize changes in motor symptoms over time and compared among the study groups.
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Day 1 to Day 27
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Change in Smartwatch-Derived Tremor Duration
Aikaikkuna: Baseline to Day 27
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Tremor-related signals will be continuously collected using a smartwatch worn on the baseline-defined clinically more affected side.
Tremor duration will be summarized at the daily level or within prespecified time windows to evaluate longitudinal changes during the intervention and follow-up periods.
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Baseline to Day 27
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Change in Home-Based Active Motor Assessment Measures
Aikaikkuna: Baseline to Day 27
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Participants will complete standardized smartphone-guided home-based motor tasks while motion signals are recorded using a smartwatch.
Assessments will be performed under standardized medication states whenever feasible.
Longitudinal changes in task-based digital motor measures will be explored during the intervention and follow-up periods.
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Baseline to Day 27
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Incidence of Adverse Events and Serious Adverse Events
Aikaikkuna: Day 1 to Day 27
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Safety will be assessed by monitoring the incidence, type, severity, duration, outcome, and relationship to STN-tTIS of adverse events (AEs) and serious adverse events (SAEs).
Potential stimulation-related adverse events include headache, dizziness, fatigue, scalp itching or erythema, sleep disturbance, mood changes, worsening of tremor, and other treatment-emergent symptoms.
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Day 1 to Day 27
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Yhteistyökumppanit ja tutkijat
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