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Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease: Protocol For a Double Blind Randomized Controlled Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai University of Sport
NOT_YET_RECRUITING
Shanghai
Shanghai University of Sport
RECRUITING
Shanghai
Contact Information
Primary
Yu Liu, Prof.
yuliu@sus.edu.cn
+86 21 65507351
Backup
Zijun Lu
luzijun@snnu.edu.cn
+86 21 65507862
Time Frame
Start Date: 2026-04-04
Estimated Completion Date: 2028-03-30
Participants
Target number of participants: 68
Treatments
Experimental: TIs-Group
Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a four-week intervention period.
Sham_comparator: Sham-TIs 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 28 sessions delivered over a four-week period, without therapeutic stimulation.
Sponsors
Leads: Shanghai University of Sport

This content was sourced from clinicaltrials.gov