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

Zhongnan Hospital

Status: Not yet enrolling

Conditions: Parkinson's Disease; Temporal Interference Stimulation (TIS)

Treatments: Device: TIS

Study type: Interventional

Funder types: Other

Identifiers

NCT07312279

2025267

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

A:STN

Experimental group

Description:

The subthalamic nucleus (STN) stimulation target

Treatment:

Device: TIS