Subthalamic Nucleus-Targeted Transcranial Temporal Interference Stimulation for Motor and Non-Motor Symptoms in Parkinson's Disease
STN-tTIS-PD
Study on the Efficacy and Safety of Subthalamic Nucleus (STN)-Targeted Transcranial Temporal Interference Stimulation (tTIS) for Motor and Non-Motor Symptoms in Parkinson's Disease (PD): A Randomized, Double-Blind, Controlled Exploratory Trial
2 other identifiers
interventional
32
1 country
1
Brief Summary
Transcranial temporal interference stimulation (tTIS) is a non-invasive deep brain stimulation method. This study aims to comprehensively explore the efficacy and safety of bilateral subthalamic nucleus (STN) tTIS on motor and non-motor symptoms in patients with Parkinson's disease (PD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 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
May 17, 2026
CompletedStudy Start
First participant enrolled
May 20, 2026
CompletedFirst Posted
Study publicly available on registry
June 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
June 4, 2026
June 1, 2026
11 months
May 17, 2026
June 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes of motor function in PD
the scores of UPDRS III \[OFF\])
Changes from baseline after 5 days of intervention (Day 5)
Secondary Outcomes (11)
Changes of motor function in PD
Day 15, Day 35 （UPDRS III [OFF] ); Day 5, Day 15, Day 35 （UPDRS III [ON])
Changes of Motor Complications in PD
Day 5, Day 15, Day 35
Assessment of changes in cognition
Day 5, Day 15, Day 35
Assessment of changes in anxiety
Day 5, Day 15, Day 35
Assessment of changes in depression
Day 5, Day 15, Day 35
- +6 more secondary outcomes
Other Outcomes (1)
Changs of brain connectivity in the PD brain
After 5 days of intervention relative to baseline
Study Arms (2)
the experimental group
EXPERIMENTALreal stimulation
the control group
SHAM COMPARATORsham stimulation
Interventions
tTIS was targeted at the bilateral STN, with stimulation delivered once daily for 20 minutes per session, for a total of five consecutive days.
The sham stimulation is administered using the same procedure as the real tTIS.
Eligibility Criteria
You may qualify if:
- Aged 50-85 years, male or female.
- Diagnosed with "clinically established" or "clinically probable" Parkinson's disease according to the 2015 MDS Clinical Diagnostic Criteria for Parkinson's Disease.
- Hoehn-Yahr stage ≥ 2, and judged by the investigator to be able to cooperate in completing scale-based assessments and MRI examinations.
- Stable regimen of anti-Parkinsonian medication for at least 4 weeks before enrollment, and agreement to maintain a stable regimen during the main study phase unless medically necessary to change.
- Written informed consent signed by the study participant.
You may not qualify if:
- Non-primary Parkinson's disease or other parkinsonism / atypical parkinsonism.
- Previous receipt of invasive neuromodulation therapies such as deep brain stimulation (DBS) or other intracranial implantation/stereotactic brain surgery.
- Presence of contraindications or high-risk conditions for transcranial electrical stimulation (e.g., incompatible metal implants/implantable electrical stimulation devices, etc.), or judged by the investigator as unsuitable to receive transcranial electrical stimulation.
- Receipt of non-invasive neuromodulation interventions such as transcranial magnetic stimulation or transcranial electrical stimulation within the past six months.
- Presence of contraindications to MRI or inability to tolerate MRI examination.
- Significant cognitive impairment or severe psychiatric symptoms that prevent completion of assessments or result in poor compliance.
- New initiation or dose adjustment of medications or treatments that significantly affect sleep architecture/consciousness status within the past 4 weeks.
- History of epilepsy.
- Pregnancy or breastfeeding.
- Any other condition judged by the investigator as unsuitable for participation in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 17, 2026
First Posted
June 4, 2026
Study Start
May 20, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2027
Last Updated
June 4, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share