STN-tTIS With Different Intervention Intervals Versus Standard Medical Treatment for Parkinson's Disease

NCT07774312 · tracked via the Priya Life Science China tracker

Sponsor

Ruijin Hospital

Phase

Not applicable

Started

2026-07-27

Last updated

2026-08-21

Condition(s) studied

Parkinson's Disease (PD)

Investigational drug(s) / intervention(s)

STN-tTIS Once WeeklySTN-tTIS Twice WeeklySTN-tTIS Five Times WeeklyStandard Antiparkinsonian Medication

STN-tTIS Once Weekly: 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.

STN-tTIS Twice Weekly: 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.

STN-tTIS Five Times Weekly: 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.

Standard Antiparkinsonian Medication: Participants continue their stable antiparkinsonian medication regimen throughout the 2-week study intervention period. No additional STN-tTIS is administered.

Study summary

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:

1. 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?
2. Do once-weekly, twice-weekly, and five-times-weekly STN-tTIS produce different changes in motor symptoms?
3. Does the STN-tTIS intervention intervals influence how long its effects persist after treatment?
4. 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.

Eligibility

Sex

ALL

Min age

50 Years

Max age

85 Years

Healthy volunteers

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.

Primary outcome measure(s)

Change From Baseline in MDS-UPDRS Part III Total Score at the End of the Intervention Period — Baseline to Day 12
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.

Trial sites (1)

Facility	City	Region	Status
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07774312 on ClinicalTrials.gov ↗ ← All trials in China