Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease

Shanghai University of Sport

Status: Enrolling

Conditions: Parkinson's Disease

Treatments: Device: Transcranial Temporal Interference Stimulation (TIS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07309198

102772024RT146

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

36 participants in 2 patient groups

TIS Group

Experimental group

Description:

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

Treatment:

Device: Transcranial Temporal Interference Stimulation (TIS)

Sham Group

Sham Comparator group

Description:

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.

Treatment:

Device: Transcranial Temporal Interference Stimulation (TIS)