TIS for Brain Network Modulation and Clinical Efficacy in Parkinson's Disease

Starting soon · Not applicable · Has a placebo group

Conditions studied: PARKINSON DISEASE (Disorder)

In brief

Parkinson's disease (PD) is a neurodegenerative disorder characterized by motor dysfunction. While deep brain stimulation (DBS) is effective, its invasive nature limits its application in early-stage patients. Temporal interference stimulation (TIS) is a novel non-invasive technique that can target deep brain structures like the globus pallidus internus (GPi) by using high-frequency electric fields. This study aims to evaluate the clinical value and underlying mechanisms of TIS in PD patients. The research is divided into two phases: Phase A investigates the immediate regulatory effects of 130 Hz and 40 Hz TIS on brain networks using concurrent fMRI-TIS. Phase B is a randomized, double-blind, sham-controlled trial to assess the long-term efficacy and safety of a 2-week TIS intervention on both motor and non-motor symptoms. The results will help clarify how TIS modulates deep brain networks and its potential as a non-invasive therapy for PD.

Key facts

Study ID

NCT07480317

Run by

Jiangsu Province Nanjing Brain Hospital

People needed

75

Starts

2026-03-20

Expected to finish

2027-03-31

Last updated by the study team

2026-03-24

Who can join

Age: 45 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with Parkinson's Disease according to the Movement Disorder Society (MDS) clinical diagnostic criteria.
• Hoehn \& Yahr Stage I-III (mild to moderate severity).
• Aged 45 to 65 years.
• Right-handed. Stable medication regimen for at least 1 hour before Phase A fMRI sessions and agreement to maintain a stable dosage during the 2-week Phase B intervention (unless clinically necessary).
• Able to provide informed consent by the participant or a legal guardian.

You may not qualify if…

• MRI contraindications, such as implanted DBS electrodes, cardiac pacemakers, or other metal implants.
• Significant cognitive impairment (MoCA score < 24) or severe psychiatric symptoms.
• History of epilepsy or structural brain lesions, including severe cerebral atrophy or cerebrovascular disease.
• Severe head tremors that would interfere with MRI scanning quality.

Where it is running

• Nanjing Brain Hospital (Affiliated Brain Hospital of Nanjing Medical University) — Nanjing, Jiangsu, China

Full record on ClinicalTrials.gov

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