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TIS for Brain Network Modulation and Clinical Efficacy in Parkinson's Disease
Sponsor: Jiangsu Province Nanjing Brain Hospital
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.
Official title: Mechanism of Temporal Interference Stimulation on Brain Networks and Its Long-term Clinical Efficacy in Parkinson's Disease
Key Details
Gender
All
Age Range
45 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
75
Start Date
2026-03-20
Completion Date
2027-03-31
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Nanjing Brain Hospital (Affiliated Brain Hospital of Nanjing Medical University)
Nanjing, Jiangsu, China