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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorJiangsu Province Nanjing Brain Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Temporal Interference Stimulation (130 Hz)
  • Temporal Interference Stimulation (40 Hz)
  • Sham Temporal Interference Stimulation

Treatment groups

75 Participants
are divided into 3 treatment groups