Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease

NCT ID: NCT07309198

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-29
• Study Completion Date: 2026-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TIS Group

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

Group Type: EXPERIMENTAL

Transcranial Temporal Interference Stimulation (TIS)

Intervention Type: 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

Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. The sham procedure consists of 10 sessions delivered over a two-week period, without therapeutic stimulation.

Group Type: SHAM_COMPARATOR

Transcranial Temporal Interference Stimulation (TIS)

Intervention Type: 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.

Interventions

Transcranial Temporal Interference Stimulation (TIS)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai University of Sport

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai University of Sport

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yu Liu, PhD

Role: CONTACT

yuliu@sus.edu.cn

+86 21 65507351

Facility Contacts

Ethics Committee of the Shanghai University of Sport

Role: primary

lunli@sus.edu.cn

+86 21 65508179

Other Identifiers

102772024RT146

Identifier Type: -

Identifier Source: org_study_id