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Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease

NCT07518290 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-04-14

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if home-based temporal interference stimulation (TIS) works to improve motor symptoms in people with Parkinson's disease (PD). It will also learn about the safety of this treatment. The main questions it aims to answer are:

1. Does home-based TIS improve movement problems such as slow movement, stiffness, and walking difficulty?
2. Are the effects maintained after the treatment ends?
3. What medical problems (adverse events) occur during treatment? Researchers will compare active TIS to a sham treatment (a look-alike procedure that does not deliver active stimulation) to see if TIS works.

Participants will:

1. Receive active TIS or sham stimulation once a day for 4 weeks at home under remote supervision
2. Visit the clinic at specific time points for movement assessments
3. Complete online questionnaires about symptoms and quality of life

Conditions

  • PARKINSON DISEASE (Disorder)
  • Motor Symptoms

Interventions

DEVICE

Home-based Transcranial Temporal Interference Stimulation (HB-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 will receive one stimulation session per day, seven days per week, for four weeks in a home-based setting under real-time remote supervision. The electrode placement is based on a standard 10-10 electroencephalography (EEG) system. For stimulation targeting the right GPi, electrode pairs will be positioned at CP3-CP6 and F3-F6; for stimulation targeting the left GPi, electrode pairs will be positioned at CP4-CP5 and F4-F5. The sham TIS condition uses the same setup and procedures but does not deliver effective stimulation, thereby maintaining blinding.

Sponsors & Collaborators

  • Shanghai University of Sport

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-04
Primary Completion
2028-01-30
Completion
2028-03-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07518290 on ClinicalTrials.gov