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Clinical Trials in China / NCT07518290
Recruiting Not applicable

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

NCT07518290 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai University of Sport
Phase
Not applicable
Started
2026-04-04
Last updated
2026-09-22

Condition(s) studied

PARKINSON DISEASE (Disorder)Motor Symptoms

Investigational drug(s) / intervention(s)

Home-based Transcranial Temporal Interference Stimulation (HB-TIS)

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.

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

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of Parkinson's disease according to established clinical criteria * Mild-to-moderate disease severity, defined as Hoehn and Yahr stage 1.5-3; * Age between 40 and 80 years; * Stable anti-parkinsonian medication regimen; * Ability to walk unaided for at least 2 minutes. Exclusion Criteria: * contraindications to TIs (e.g., metal implantation, pacemakers, etc.); * the use of DBS; * significant cognitive impairment as defined by the diagnosis of Alzheimer's disease or dementia, or Montreal Cognitive Assessment (MoCA) total score\<21, a recommended threshold for dementia in PD; * diagnosis of other neurological conditions such as multiple sclerosis, previous stroke; * report of severe lower-extremity arthritis, pain, or orthopedic problems significantly affecting gait; * physician-diagnosis of schizophrenia or other psychiatric illness; * an unwillingness to cooperate or participate in the study protocol. Eligible and interested participants will then be enrolled and complete baseline assessments before the randomization.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Shanghai University of Sport Shanghai Shanghai Municipality Not Yet Recruiting
Shanghai University of Sport Shanghai Shanghai Municipality Recruiting

More Shanghai University of Sport trials in China

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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 NCT07518290 on ClinicalTrials.gov ↗ ← All trials in China