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

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

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

Study Overview

• Status: Recruiting
• Conditions: PARKINSON DISEASE (Disorder); Motor Symptoms
• Intervention / Treatment: Device: Home-based Transcranial Temporal Interference Stimulation (HB-TIS)

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu Liu, Prof.; Phone Number: +86 21 65507351; Email: yuliu@sus.edu.cn
• Study Contact Backup: Name: Zijun Lu; Phone Number: +86 21 65507862; Email: luzijun@snnu.edu.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200438
      • Recruiting
      • Shanghai University of Sport
      • Contact: Zijun Lu; Phone Number: +86 21 65507862; Email: luzijun@snnu.edu.cn
    • Shanghai, Shanghai Municipality, China, 200438
      • Not yet recruiting
      • Shanghai University of Sport
      • Contact: Zijun Lu; Phone Number: +86 21 65507862; Email: luzijun@snnu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time to complete sit-to-stand and stand-to-sit transitions in 3m-iTUG	Time (in seconds) required to stand up from a seated position and return to sitting during the 3m-iTUG test, in which participants stand up from a chair, walk 3 meters, perform a 180-degree turn, walk back, and sit down. Lower values indicate better performance.	Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Turning time during 3m-iTUG	Time (in seconds) required to complete the 180-degree turn during the 3m-iTUG test, which includes standing up from a seated position, walking 3 meters, turning, walking back, and sitting down. Lower values indicate better performance.	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	The number of participants who had a clinically meaningful improvement after the stimulation within each group. Clinically meaningful improvement will be defined as a reduction of ≥ 5 points in the MDS-UPDRS-III total score. For gait outcomes, an increase in gait speed of ≥ 0.10 m/s or ≥ 10% improvement from baseline will be considered meaningful	Baseline, immediately after 1 and 4 weeks of intervention
MDS-UPDRS-III sub scores	Absolute change from baseline in four prespecified MDS-UPDRS-III sub scores in medication- "ON" and- "OFF" states, including rigidity, bradykinesia, tremor, and axial symptoms, 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
Geriatric Anxiety Inventory (GAI)	A 20-item self-report scale (range: 0-20), with higher scores indicating greater anxiety severity; scores ≥8-10 suggest clinically relevant anxiety.	Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Geriatric Depression Scale (GDS)	A 15-item self-report scale (range: 0-15), with higher scores indicating greater depressive symptom severity; categorized as normal (0-4), mild (5-8), moderate (9-11), and severe (12-15).	Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT)	a 25-item self-report scale assessing autonomic dysfunction in Parkinson's disease (range: 0-69), with higher scores indicating more severe autonomic symptoms.	Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Montreal Cognitive Assessment (MOCA)	a 30-point screening tool (range: 0-30), with lower scores indicating worse global cognitive function.	Baseline, after 4 weeks of intervention
Trail Making Test (Part A/B)	The Trail Making Test assesses processing speed (Part A) and executive function (Part B), with longer completion times indicating poorer cognitive performance.	Baseline, after 4 weeks of intervention
The Digit Span Test evaluates (DST)	The Digit Span Test evaluates (DST) attention and working memory, with higher scores indicating better cognitive performance.	Baseline, after 4 weeks of intervention
Parkinson's Disease Sleep Scale-2 (PDSS-II)	a 15-item scale (range: 0-60), with higher scores indicating more severe sleep disturbances.	Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Epworth Sleeping Scale (ESS)	an 8-item scale (range: 0-24), with higher scores indicating greater daytime sleepiness; scores ≥10 suggest excessive daytime sleepiness.	Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Parkinson's Disease Questionnaire-39 (PDQ-39)	a 39-item questionnaire (range: 0-100, scaled), with higher scores indicating poorer quality of life.	Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Home Diary Assessment of Motor States	Participants will record daily information including perceived medication- "ON" and- "OFF" periods [ref], time to medication onset, daily physical activity, sleep duration, and the occurrence of any adverse events.	Baseline, immediately after 1, 2, 3, 4 weeks of intervention
Safety related outcomes	Adverse events: The incidence and severity of adverse events recorded throughout the intervention and follow-up period, with higher frequency and severity indicating lower safety.; Attrition rate: The proportion of participants who withdraw before completing the intervention, with higher attrition indicating lower tolerability and acceptability.; Adherence rate: The proportion of completed stimulation sessions relative to the total prescribed sessions, with higher adherence indicating better feasibility and tolerability.	After each intervention session (28 sessions over 4 weeks).

Collaborators and Investigators

• Sponsor: Shanghai University of Sport

Study record dates

Study Major Dates

• Study Start (Estimated): April 4, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Parkinson disease; Home-based intervention; Transcranial temporal interference stimulation; Motor symptom
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 102772025RT234; 11932013 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No