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

Condition(s) studied

Investigational drug(s) / intervention(s)

Temporal Interference Stimulation (130 Hz): High-frequency sinewave currents (carrier frequency: 2000 Hz and 2130 Hz) are delivered via two pairs of scalp electrodes. The current intensity is 2-4 mA (individualized). In Phase B, stimulation lasts 30 minutes daily for 2 weeks (10 sessions).

Temporal Interference Stimulation (40 Hz): High-frequency sinewave currents (carrier frequency: 2000 Hz and 2040 Hz) are delivered via two pairs of scalp electrodes. Parameters are identical to the 130 Hz group except for the envelope frequency.

Sham Temporal Interference Stimulation: The device provides only a 20-second ramp-up and 20-second ramp-down of current to mimic the skin sensation of active stimulation, without continuous therapeutic stimulation.

Study summary

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

Primary outcome measure(s)

• Change from Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) total score. — Baseline, 2 weeks (immediately after the 10th intervention session), and 1 month (follow-up).
  The MDS-UPDRS Part III is a clinician-rated scale used to assess the motor signs of Parkinson's disease. It includes 18 items (33 scores total), with each item ranging from 0 (normal) to 4 (severe). The total score ranges from 0 to 132, where higher scores represent greater motor impairment.

Trial sites (1)

More Jiangsu Province Nanjing Brain Hospital trials in China

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