Motor Symptoms, PARKINSON DISEASE (Disorder)
Conditions
Keywords
Parkinson disease, Transcranial temporal interference stimulation, Home-based intervention, Motor symptom, Randomized controlled trial
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. 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
Interventions
DEVICEHome-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.
Sponsors
Shanghai University of Sport
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| Turning time during 3m-iTUG | Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention | 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. |
| Response rate of MDS-UPDRS-III and gait speed | Baseline, immediately after 1 and 4 weeks of intervention | 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 |
| MDS-UPDRS-III sub scores | Baseline, immediately after 1 and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention | 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). |
| Geriatric Anxiety Inventory (GAI) | Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention | A 20-item self-report scale (range: 0-20), with higher scores indicating greater anxiety severity; scores ≥8-10 suggest clinically relevant anxiety. |
| Geriatric Depression Scale (GDS) | Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention | 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). |
| Scales for Outcomes in Parkinson's Disease-Autonomic (SCOPA-AUT) | Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention | a 25-item self-report scale assessing autonomic dysfunction in Parkinson's disease (range: 0-69), with higher scores indicating more severe autonomic symptoms. |
| Montreal Cognitive Assessment (MOCA) | Baseline, after 4 weeks of intervention | a 30-point screening tool (range: 0-30), with lower scores indicating worse global cognitive function. |
| Trail Making Test (Part A/B) | Baseline, after 4 weeks of intervention | The Trail Making Test assesses processing speed (Part A) and executive function (Part B), with longer completion times indicating poorer cognitive performance. |
| The Digit Span Test evaluates (DST) | Baseline, after 4 weeks of intervention | The Digit Span Test evaluates (DST) attention and working memory, with higher scores indicating better cognitive performance. |
| Parkinson's Disease Sleep Scale-2 (PDSS-II) | Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention | a 15-item scale (range: 0-60), with higher scores indicating more severe sleep disturbances. |
| Epworth Sleeping Scale (ESS) | Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention | an 8-item scale (range: 0-24), with higher scores indicating greater daytime sleepiness; scores ≥10 suggest excessive daytime sleepiness. |
| Parkinson's Disease Questionnaire-39 (PDQ-39) | Baseline, after 2 weeks and 4 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention | a 39-item questionnaire (range: 0-100, scaled), with higher scores indicating poorer quality of life. |
| Home Diary Assessment of Motor States | Baseline, immediately after 1, 2, 3, 4 weeks of intervention | 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. |
| Safety related outcomes | After each intervention session (28 sessions over 4 weeks). | 1. 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. 2. Attrition rate: The proportion of participants who withdraw before completing the intervention, with higher attrition indicating lower tolerability and acceptability. 3. Adherence rate: The proportion of completed stimulation sessions relative to the total prescribed sessions, with higher adherence indicating better feasibility and tolerability. |
Countries
China
Contacts
CONTACTYu Liu, Prof.
CONTACTZijun Lu
Outcome results
None listed