An interventional study of STN-tTIS Once Weekly and STN-tTIS Twice Weekly in Parkinson's Disease (PD), sponsored by Ruijin Hospital. Recruiting at 1 site in China. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Ruijin Hospital · Not applicable, Interventional, and Treatment
Among 20 studies in Parkinson Disease by Ruijin Hospital — 9 open to participants now, 9 under way, none of them phase 3. Parkinson Disease · Ruijin Hospital.
Among the 20 studies in Parkinson Disease by Ruijin Hospital, this one is the 5th largest by planned enrollment of the 18 interventional ones, is one of 3 that started in 2026, is one of 16 with no phase, and was the 20th registered.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →9 of the 20 studies in Parkinson Disease by Ruijin Hospital are open now, in 1 country. Each count lists the studies.
Of the 748 Parkinson Disease studies recruiting now, 311 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 63 take children under 18; 189 take healthy volunteers.
This study: 50 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2016; this study’s year is marked. 3 started in 2026.
Median enrollment 30 across the 18 interventional studies, 360 across the 2 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
3 of the studies in Parkinson Disease by Ruijin Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07018388Ruijin HospitalIntrapatient Comparison of STN and GPi tTIS in PD | 2026-11-01 |
| NCT07353463Ruijin HospitalShanghai Clinical Cohort - Parkinson's Disease (Reserve) | 2026-12-31 |
| NCT07774312Ruijin HospitalSTN-tTIS With Different Intervention Intervals Versus Standard Medical Treatment for Parkinson's Disease | 2027-03-15 |
Among the 20 studies in Parkinson Disease by Ruijin Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
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:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) once weekly for 2 weeks in addition to stable antiparkinsonian medication.
Device: STN-tTIS Once Weekly · Drug: Standard Antiparkinsonian Medication
Participants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) twice weekly for 2 weeks in addition to stable antiparkinsonian medication.
Device: STN-tTIS Twice Weekly · Drug: Standard Antiparkinsonian Medication
Participants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) five times weekly for 2 weeks in addition to stable antiparkinsonian medication.
Device: STN-tTIS Five Times Weekly · Drug: Standard Antiparkinsonian Medication
Participants continue their stable antiparkinsonian medication regimen for 2 weeks without additional STN-tTIS.
Drug: Standard 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.
Also known as: Transcranial Temporal Interference Stimulation
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.
Also known as: Transcranial Temporal Interference Stimulation
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.
Also known as: Transcranial Temporal Interference Stimulation
Participants continue their stable antiparkinsonian medication regimen throughout the 2-week study intervention period. No additional STN-tTIS is administered.
Change From Baseline in MDS-UPDRS Part III Total Score at the End of the Intervention Period
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.
Time frame: Baseline to Day 12
Change From Baseline in MDS-UPDRS Part I Score
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.
Time frame: Baseline to Day 12 and Day 27
Change From Baseline in MDS-UPDRS Part II Score
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.
Time frame: Baseline to Day 12 and Day 27
Change From Baseline in MDS-UPDRS Part IV Score
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
Time frame: Baseline to Day 12 and Day 27
Change From Baseline in Non-Motor Symptoms Scale (NMSS) Score
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.
Time frame: Baseline to Day 12 and Day 27
Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Score
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.
Time frame: Baseline to Day 12 and Day 27
Change From Baseline in Parkinson's Disease Sleep Scale (PDSS) Score
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.
Time frame: Baseline to Day 12 and Day 27
Change in Remotely Assessed MDS-UPDRS Part III Score
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.
Time frame: Day 1 to Day 27
Change in Smartwatch-Derived Tremor Duration
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.
Time frame: Baseline to Day 27
Change in Home-Based Active Motor Assessment Measures
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.
Time frame: Baseline to Day 27
Incidence of Adverse Events and Serious Adverse Events
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.
Time frame: Day 1 to Day 27
Plan to share: Undecided
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