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

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

Overview

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

• 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 re

Primary outcome measures

• 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 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]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

China · 2 centers

• Shanghai University of Sport — Shanghai
• Shanghai University of Sport — Shanghai

Identifiers

NCT: NCT07518290 · 102772025RT234 · 11932013

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗