Study on the Efficacy of Temporal Interference Stimulation (TIS) for Parkinson's Disease

NCT ID: NCT07312279

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2026-12-31

Brief Summary

The primary objective of this clinical study is to evaluate the therapeutic efficacy of Temporal Interference Stimulation (TIS), a non-invasive deep brain stimulation technique, in patients with Parkinson's disease, and to further investigate its potential mechanisms of action. Although TIS offers lower stimulation intensity and precision compared to conventional Deep Brain Stimulation (DBS), it possesses the distinct advantage of being non-invasive. This study utilizes TIS to explore different stimulation targets analogous to those used in DBS for Parkinson's disease, thereby providing valuable insights for subsequent DBS surgical interventions. The findings will contribute preliminary exploratory evidence regarding the application of non-invasive deep brain stimulation technology in the treatment of Parkinson's disease.

Conditions

Temporal Interference Stimulation (TIS); Parkinson's Disease

Keywords

TIS; Parkinson; UPDRS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A:STN

The subthalamic nucleus (STN) stimulation target

Group Type: EXPERIMENTAL

TIS

Intervention Type: DEVICE

Temporal Interference Stimulation

Interventions

TIS

Temporal Interference Stimulation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adult males or females aged 40 years or above;

2. Diagnosed with idiopathic Parkinson's disease according to the UK Brain Bank Criteria, with onset after 40 years of age;

3. Previous or current dopaminergic replacement therapy (e.g., levodopa) with good response; (4) Hoehn and Yahr (H&Y) stage 1.5-2.5;

4. Ability to walk independently without assistive devices for at least 5 minutes;

5. Absence of severe freezing of gait (FOG);

6. Disease duration ≥2 years since diagnosis, with stable clinical condition and ability to comply with study assessments and interventions;

7. Stable medication dosage for at least 4 weeks prior to the study;

8. Hoehn and Yahr (H&Y) stage 1.5-2.5;

9. Signed informed consent, with the participant or legal guardian capable of understanding and willing to participate in the study.

Exclusion Criteria

1. Presence of other neurological disorders that may interfere with the study

2. Mild or greater cognitive impairment (MoCA score ≤23)

3. Orthopedic or other health conditions that may affect gait or balance

4. Contraindications to MRI scanning, such as claustrophobia

5. History of antipsychotic, antidepressant, or other medications that may affect dopamine levels

6. Other significant psychiatric history

7. Contraindications including history of epilepsy, traumatic brain injury, or implanted metal devices in the brain or heart (e.g., stimulators, pacemakers)

8. History of electroconvulsive therapy

9. Concurrent participation in other gait- or balance-related intervention training

10. Physician-diagnosed cardiovascular risk factors for exercise.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongnan Hospital

OTHER

Sponsor Role: lead

Responsible Party

BinMei

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

2025267

Identifier Type: -

Identifier Source: org_study_id