TIS for Brain Network Modulation and Clinical Efficacy in Parkinson's Disease
PD TIS
Mechanism of Temporal Interference Stimulation on Brain Networks and Its Long-term Clinical Efficacy in Parkinson's Disease
1 other identifier
interventional
75
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2026
CompletedFirst Posted
Study publicly available on registry
March 18, 2026
CompletedStudy Start
First participant enrolled
March 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
March 24, 2026
March 1, 2026
5 months
March 14, 2026
March 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) total score.
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.
Baseline, 2 weeks (immediately after the 10th intervention session), and 1 month (follow-up).
Secondary Outcomes (1)
Changes in Brain Network Functional Connectivity and Amplitude of Low-frequency Fluctuations (ALFF).
Baseline, 20 minutes (during concurrent TIS), and 8 minutes (immediately post-stimulation) for Phase A ; Baseline and 2 weeks for Phase B.
Study Arms (3)
130 Hz TIS Group
EXPERIMENTALParticipants receive active Temporal Interference Stimulation (TIS) with a 130 Hz envelope frequency targeting the right globus pallidus internus (GPi).
40 Hz TIS Group
EXPERIMENTALParticipants receive active TIS with a 40 Hz envelope frequency targeting the right GPi.
Sham Group
SHAM COMPARATORParticipants receive sham stimulation targeting the right GPi.
Interventions
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).
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.
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing Brain Hospital (Affiliated Brain Hospital of Nanjing Medical University)
Nanjing, Jiangsu, 210029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sham stimulation is used for blinding. It provides only a 20-second ramp-up and ramp-down of current to mimic the skin sensation of active stimulation.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Chief Physician
Study Record Dates
First Submitted
March 14, 2026
First Posted
March 18, 2026
Study Start
March 20, 2026
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
March 24, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared to protect the privacy of the patients and because the data is currently being used for institutional research and future academic publications.