NCT07698236Enrolling by invitation
Temporal Interference Noninvasive Deep Brain Stimulation for Idiopathic Parkinson's Disease and Parkinsonian Syndromes: Effects and Target Exploration
A Study on the Therapeutic Effects and Target Exploration of Temporal Interference-Based Noninvasive Deep Brain Stimulation in Patients With Idiopathic Parkinson's Disease and Parkinsonian Syndromes
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
This study aims to explore the therapeutic effects of noninvasive deep brain electrical stimulation using temporal interference principles (Temporal Interference Stimulation, TIS) on both motor and non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes, and to investigate strategies for optimal stimulation target selection. A prospective, single-center, double-blind, randomized, crossover design will be implemented. Participants will be recruited from outpatient and inpatient departments of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. The primary hypothesis is that TIS will significantly improve motor symptoms in patients with Parkinson's disease and Parkinsonian syndromes. The primary outcome measure will be the change in the MDS-UPDRS Part III score from baseline to post-stimulation. This study is expected to provide direct evidence supporting the clinical application and target selection strategies of noninvasive deep brain stimulation for the treatment of Parkinson's disease and Parkinsonian syndromes.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 8 Dec 2025
- Start date
- 3 Jul 2026
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Ruijin Hospital
- Diseases
- Parkinson disease
- NCT number
- NCT07698236
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 3 Jul 2026 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with deep brain stimulation (DBS) or other invasive brain stimulation therapies.
Other illness
- Presence of other neurological or psychiatric disorders that may interfere with study participation or outcomes.
- Orthopedic or other medical conditions that could affect gait or balance.
- History of taking antipsychotic, antidepressant, or other medications that may affect dopamine levels.
- Contraindications to electrical stimulation, such as implanted cardiac pacemakers or a history of epilepsy.
- History of electroconvulsive therapy (ECT).
- Severe comorbidities, including cardiovascular disease, respiratory disease, or hepatic/renal dysfunction.
Other
- Contraindications to MRI, such as claustrophobia or other factors making MRI unsuitable.
Who the study is looking for
- Aged 40 to 80 years, diagnosed with idiopathic Parkinson's disease or Parkinsonian syndromes according to the Movement Disorder Society (MDS) diagnostic criteria.
- Receiving stable doses of levodopa or other dopaminergic medications for at least 4 weeks prior to enrollment, with a documented response to levodopa; medication regimen must remain unchanged during the study.
- Hoehn and Yahr (H\&Y) stage ≤ 3 in the "ON" medication state.
- Normal cognitive function, defined as a Mini-Mental State Examination (MMSE) score ≥ 24.
- Able to maintain and cooperate with Parkinson's disease symptom diaries.
- Signed written informed consent.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.