PARKINSON DISEASE (Disorder)NCT07518290
Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease
A study testing Home-based Transcranial Temporal Interference Stimulation (HB-TIS) in people with PARKINSON DISEASE (Disorder) and Motor Symptoms, run by Shanghai University of Sport at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- PARKINSON DISEASE (Disorder), Motor Symptoms
- What is being tested?
- Home-based Transcranial Temporal Interference Stimulation (HB-TIS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 2 sitesChina
- Study dates
- 4 Apr 2026to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Shanghai University of Sport
Shanghai, Shanghai Municipality, 200438
Zijun Lu, +86 21 65507862, luzijun@snnu.edu.cn
- Recruiting
Shanghai University of Sport
Shanghai, Shanghai Municipality, 200438
Zijun Lu, +86 21 65507862, luzijun@snnu.edu.cn
About this study
Official title: 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:
- Does home-based TIS improve movement problems such as slow movement, stiffness, and walking difficulty?
- Are the effects maintained after the treatment ends?
- 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.
Read more
Participants will:
- Receive active TIS or sham stimulation once a day for 4 weeks at home under remote supervision
- Visit the clinic at specific time points for movement assessments
- Complete online questionnaires about symptoms and quality of life
- Conditions
- PARKINSON DISEASE (Disorder), Motor Symptoms
- Being tested
- Home-based Transcranial Temporal Interference Stimulation (HB-TIS)
- Keywords
- Parkinson disease, Transcranial temporal interference stimulation, Home-based intervention, Motor symptom, Randomized controlled trial
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Home-based Transcranial Temporal Interference Stimulation (HB-TIS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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
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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: After each intervention session (28 sessions over 4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start4 Apr 2026
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PARKINSON DISEASE (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Liu, Shanghai University of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518290
- Sponsor's protocol ID
- 102772025RT234
- Other IDs
- 11932013
- Status last verified
- Sep 2026
- First submitted
- 30 Mar 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Supervised Home-based Transcranial Temporal Interference Stimulation on Motor Symptoms in Parkinson's Disease: Protocol For a Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07518290
- Acronym / sponsor ID
- 102772025RT234
- Conditions
- PARKINSON DISEASE (Disorder), Motor Symptoms
- Keywords
- Parkinson disease, Transcranial temporal interference stimulation, Home-based intervention, Motor symptom, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Shanghai University of SportUniversity, hospital or other
- Study start
- 4 Apr 2026 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does home-based TIS improve movement problems such as slow movement, stiffness, and walking difficulty?
- Are the effects maintained after the treatment ends?
- 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:
- Receive active TIS or sham stimulation once a day for 4 weeks at home under remote supervision
- Visit the clinic at specific time points for movement assessments
- Complete online questionnaires about symptoms and quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIs-Group | Experimental | Device: Home-based Transcranial Temporal Interference Stimulation (HB-TIS)Participants in this arm will receive active transcranial temporal interference stimulation targeting the internal globus pallidus over a four-week intervention period. |
| Sham-TIs Group | Sham comparator | Device: Home-based Transcranial Temporal Interference Stimulation (HB-TIS)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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Sham-TIs Group, TIs-Group |
Primary outcome
Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III)
Time frame: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
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).
The time to complete 3-meter instrumented Timed Up and Go (iTUG) test
Time frame: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
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.
15 secondary outcomes
The time to complete sit-to-stand and stand-to-sit transitions in 3m-iTUG
Time frame: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Turning time during 3m-iTUG
Time frame: 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
Time frame: Baseline, immediately after 1 and 4 weeks of intervention
MDS-UPDRS-III sub scores
Time frame: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Geriatric Anxiety Inventory (GAI)
Time frame: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Geriatric Depression Scale (GDS)
Time frame: 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)
Time frame: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Montreal Cognitive Assessment (MOCA)
Time frame: Baseline, after 4 weeks of intervention
Trail Making Test (Part A/B)
Time frame: Baseline, after 4 weeks of intervention
The Digit Span Test evaluates (DST)
Time frame: Baseline, after 4 weeks of intervention
Parkinson's Disease Sleep Scale-2 (PDSS-II)
Time frame: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Epworth Sleeping Scale (ESS)
Time frame: 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)
Time frame: Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention
Home Diary Assessment of Motor States
Time frame: Baseline, immediately after 1, 2, 3, 4 weeks of intervention
Safety related outcomes
Time frame: After each intervention session (28 sessions over 4 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based Transcranial Temporal Interference Stimulation (HB-TIS) in people with PARKINSON DISEASE (Disorder) and Motor Symptoms, run by Shanghai University of Sport at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Liu, Prof. (+86 21 65507351, yuliu@sus.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) (time frame: Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.