NCT07518290

Brief 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. 1.Does home-based TIS improve movement problems such as slow movement, stiffness, and walking difficulty?
  2. 2.Are the effects maintained after the treatment ends?
  3. 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.
  4. 4.Receive active TIS or sham stimulation once a day for 4 weeks at home under remote supervision
  5. 5.Visit the clinic at specific time points for movement assessments
  6. 6.Complete online questionnaires about symptoms and quality of life

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Apr 2026Mar 2028

First Submitted

Initial submission to the registry

March 30, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 4, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

March 30, 2026

Last Update Submit

April 9, 2026

Conditions

PARKINSON DISEASE (Disorder)Motor Symptoms

Keywords

Parkinson diseaseTranscranial temporal interference stimulationHome-based interventionMotor symptomRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III)

    Change in motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III). The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment (worse outcome).

    Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

  • The time to complete 3-meter instrumented Timed Up and Go (iTUG) test

    Participants will wear six wearable sensors of Mobility Lab system (Clario, Philadelphia, PA) to measure the kinematic data when performing iTUG test. In each trial, participants will be asked to stand up from a chair, walk straightforward for 3 meters, make a 180-degree turn, walk back straightly to the chair and sit down.

    Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

Secondary Outcomes (15)

  • The time to complete sit-to-stand and stand-to-sit transitions in 3m-iTUG

    Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

  • Turning time during 3m-iTUG

    Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

  • Response rate of MDS-UPDRS-III and gait speed

    Baseline, immediately after 1 and 4 weeks of intervention

  • MDS-UPDRS-III sub scores

    Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

  • Geriatric Anxiety Inventory (GAI)

    Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention

  • +10 more secondary outcomes

Study Arms (2)

TIs-Group

EXPERIMENTAL

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

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

Sham-TIs Group

SHAM COMPARATOR

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.

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

Interventions

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

Sham-TIs GroupTIs-Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai University of Sport

Shanghai, Shanghai Municipality, 200438, China

NOT YET RECRUITING

Shanghai University of Sport

Shanghai, Shanghai Municipality, 200438, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Yu Liu, Prof.

CONTACT

+86 21 65507351yuliu@sus.edu.cn

Zijun Lu

CONTACT

+86 21 65507862luzijun@snnu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 8, 2026

Study Start

April 4, 2026

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

March 30, 2028

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)