Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease

NCT07309198 | Completed Results

• 1 other identifier: 102772024RT146
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether a type of brain stimulation called transcranial temporal interference stimulation (TIS) of the internal globus pallidus (GPi) can help improve movement symptoms in people with Parkinson's disease. The study will also look at how TIS changes brain activity related to these improvements. The main questions this study aims to answer are:

• How much can repeated TIS sessions improve movement symptoms in people with Parkinson's disease?
• Can these improvements last for up to two months after the treatment ends?
• What changes in brain activity happen along with the improvements? Researchers will compare people who receive active TIS with those who receive sham (placebo-like) stimulation to see whether active TIS leads to better movement outcomes. Participants will:
• Receive 10 sessions of active or sham TIS over two weeks
• Complete movement assessments during the two-week treatment and again 2, 4, and 8 weeks afterward
• Complete brain activity assessments before and after the two-week treatment

Conditions

Parkinson's Disease

Keywords

transcranial temporal interference stimulation; TIS; Parkinson's disease; motor symptoms

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score

  Change in motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III). The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment (worse outcome).

  Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

• Participants With a ≥5-point Reduction From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score

  A responder was defined as a participant with a reduction of at least 5 points from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) total score. Scores range from 0 to 132, with higher scores indicating more severe motor impairment; therefore, a reduction in score indicates improvement.

  Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

Secondary Outcomes (11)

• Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score

  Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

• Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score

  Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

• Change From Baseline in the Epworth Sleepiness Scale Score

  Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

• Change From Baseline in the Parkinson's Disease Sleep Scale-2 Score

  Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

• Change From Baseline in the Gait Performance Measures

  Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

Other Outcomes (11)

• Change From Baseline in the Home Diary Assessment of Motor States (Medication-ON Without Dyskinesia)

  Baseline, weekly averages during weeks 1 and 2 of the intervention

• Change From Baseline in the Home Diary Assessment of Motor States (Medication-OFF)

  Baseline, weekly averages during weeks 1 and 2 of the intervention

• Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index

  Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

Study Arms (2)

TIS Group

EXPERIMENTAL

Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a two-week intervention period.

Device: Transcranial Temporal Interference Stimulation (TIS)

Sham Group

SHAM COMPARATOR

Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period, without therapeutic stimulation.

Device: Transcranial Temporal Interference Stimulation (TIS)

Interventions

Transcranial Temporal Interference Stimulation (TIS) DEVICE

Transcranial temporal interference stimulation (TIS) is a noninvasive brain stimulation technique that delivers two high-frequency alternating currents through scalp electrodes to generate a low-frequency interference field in deep brain regions. In this study, TIS targets the internal globus pallidus (GPi) to modulate neural activity in people with Parkinson's disease. Participants receive 10 stimulation sessions over two weeks. The sham TIS condition uses the same setup but applies low-frequency currents without generating an interference pattern.

Sham Group; TIS Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A physician-diagnosed idiopathic Parkinson's disease (PD) according to the Movement Disorder Society (MDS) diagnostic criteria, with onset after the age of 40.
• Stable antiparkinsonian medication regimen, including levodopa-containing therapy, unchanged for at least 4 weeks before and during the trial.
• Hoehn and Yahr (H\&Y) stages 1.5 to 3 and ability to walk unassisted.
• Absence of dementia, defined as a Montreal Cognitive Assessment (MoCA) score ≥ 21.

You may not qualify if:

• Any contraindication for MRI or transcranial temporal interference stimulation (TIS), including claustrophobia, metallic implants in the head or heart, or a history of electroconvulsive therapy.
• Current use of antipsychotic, antidepressant, or other dopamine-modulating medications.
• Presence of orthopedic conditions that may interfere with motor assessments, such as osteoarthritis or recent orthopedic surgery (within the past 6 months).
• History of physician-diagnosed major psychiatric illness.
• Physician-diagnosed cardiovascular risks that could contraindicate exercise or study participation.
• Prior history of deep brain stimulation (DBS) surgery.

Sponsors & Collaborators

• Shanghai University of Sport: lead

Study Sites (1)

Shanghai University of Sport

Shanghai, Shanghai Municipality, 200438, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Yu Liu
• Organization: Shanghai University of Sport

yuliu@sus.edu.cn

+ 86 021 65507351

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shanghai University of Sport

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: December 30, 2025
• Study Start: December 29, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 15, 2026
• Last Updated: June 24, 2026
• Results First Posted: June 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)