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

NCT07312279 | Not Yet Recruiting

• 1 other identifier: 2025267
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• UPDRS-3

  Changes in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) scores from baseline to immediately after and 1 month after a single treatment session.

  From enrollment through the 3-month follow-up

Study Arms (1)

A:STN

EXPERIMENTAL

The subthalamic nucleus (STN) stimulation target

Device: TIS

Interventions

TIS DEVICE

Temporal Interference Stimulation

A:STN

Eligibility Criteria

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

You may qualify if:

• Adult males or females aged 40 years or above;
• Diagnosed with idiopathic Parkinson's disease according to the UK Brain Bank Criteria, with onset after 40 years of age;
• Previous or current dopaminergic replacement therapy (e.g., levodopa) with good response; (4) Hoehn and Yahr (H\&Y) stage 1.5-2.5;
• Ability to walk independently without assistive devices for at least 5 minutes;
• Absence of severe freezing of gait (FOG);
• Disease duration ≥2 years since diagnosis, with stable clinical condition and ability to comply with study assessments and interventions;
• Stable medication dosage for at least 4 weeks prior to the study;
• Hoehn and Yahr (H\&Y) stage 1.5-2.5;
• Signed informed consent, with the participant or legal guardian capable of understanding and willing to participate in the study.

You may not qualify if:

• Presence of other neurological disorders that may interfere with the study
• Mild or greater cognitive impairment (MoCA score ≤23)
• Orthopedic or other health conditions that may affect gait or balance
• Contraindications to MRI scanning, such as claustrophobia
• History of antipsychotic, antidepressant, or other medications that may affect dopamine levels
• Other significant psychiatric history
• Contraindications including history of epilepsy, traumatic brain injury, or implanted metal devices in the brain or heart (e.g., stimulators, pacemakers)
• History of electroconvulsive therapy
• Concurrent participation in other gait- or balance-related intervention training
• Physician-diagnosed cardiovascular risk factors for exercise.

Sponsors & Collaborators

• Zhongnan Hospital: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 31, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12