Temporal Interference Noninvasive Deep Brain Stimulation for Idiopathic Parkinson's Disease and Parkinsonian Syndromes: Effects and Target Exploration

NCT07698236 | Enrolling By Invitation DMC

• 1 other identifier: 2025-622
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease; Parkinsonian Syndromes

Keywords

Parkinson's Disease and Parkinsonian Syndromes; Temporal Interference Noninvasive Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• Efficacy of temporal interference stimulation (TIS) on motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

  The MDS-UPDRS Part III is a rater-administered motor examination used to evaluate the severity of motor impairment in patients with idiopathic Parkinson's disease and Parkinsonian syndromes. The total score ranges from 0 to 132, with lower scores indicating less severe motor symptoms. Changes from baseline after real or sham stimulation will be analyzed and compared between groups.

  Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

Secondary Outcomes (15)

• Secondary motor outcome

  Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

• Secondary motor outcome

  Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

• Secondary motor outcome

  Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

• Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

  Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

• Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes

  Baseline, 3 days after sham stimulation, and 3 days after active stimulation.

Study Arms (5)

GPi TIS

EXPERIMENTAL

Participants with PD or PDS receive TIS targeting the contralateral globus pallidus internus (GPi). Each group consists of 10 patients with PD and 10 patients with PDS.

Device: AB Temporal Interference Stimulation; Device: BA Temporal Interference Stimulation

STN TIS

EXPERIMENTAL

Participants with PD or PDS receive TIS targeting the contralateral subthalamic nucleus (STN). Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.

Device: AB Temporal Interference Stimulation; Device: BA Temporal Interference Stimulation

Putamen TIS

EXPERIMENTAL

Participants with PD or PDS receive TIS targeting the contralateral putamen. Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.

Device: AB Temporal Interference Stimulation; Device: BA Temporal Interference Stimulation

LHA TIS

EXPERIMENTAL

Participants with PD or PDS receive TIS targeting the contralateral lateral hypothalamic area (LHA). Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.

Device: AB Temporal Interference Stimulation; Device: BA Temporal Interference Stimulation

Dentate TIS

EXPERIMENTAL

Participants with PD or PDS receive TIS targeting the ipsilateral cerebellar dentate nucleus. Each group consists of 10 patients with PD and 10 patients with Parkinsonian syndromes.

Device: AB Temporal Interference Stimulation; Device: BA Temporal Interference Stimulation

Interventions

AB Temporal Interference Stimulation DEVICE

Participants with PD or PDS receive TIS. Each session lasts 30 minutes for 3 consecutive days. The study uses a crossover design with AB sequence (Active → Sham). Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.

Dentate TIS; GPi TIS; LHA TIS; Putamen TIS; STN TIS

BA Temporal Interference Stimulation DEVICE

Participants with PD or PDS receive TIS. Each session lasts 30 minutes for 3 consecutive days. The study uses a crossover design with BA sequence (Sham → Active). Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz. Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;

Dentate TIS; GPi TIS; LHA TIS; Putamen TIS; STN TIS

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of other neurological or psychiatric disorders that may interfere with study participation or outcomes.
• Previous treatment with deep brain stimulation (DBS) or other invasive brain stimulation therapies.
• Orthopedic or other medical conditions that could affect gait or balance.
• Contraindications to MRI, such as claustrophobia or other factors making MRI unsuitable.
• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Jiao Tong University School of Medicine Affiliated Ruijin Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: July 13, 2026
• Study Start: July 3, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)