Subthalamic Nucleus-Targeted Transcranial Temporal Interference Stimulation for Motor and Non-Motor Symptoms in Parkinson's Disease (STN-tTIS-PD)

June 2, 2026 updated by: Xiaoying Zhu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, randomized, double-blind, sham-controlled trial for Parkinson's disease (PD). The transcranial temporal interference stimulation (tTIS) intervention period is 5 days, with follow-up assessments conducted immediately after the intervention, 10 days post-intervention, and 30 days post-intervention. The real stimulation group receives bilateral subthalamic nucleus (STN) -targeted tTIS once daily for 5 days. Stimulation parameters: carrier frequencies of 2000/2130 Hz (Δf = 130 Hz), with stimulation lasting 20 minutes on each side. Before the intervention, T1-weighted structural images are acquired for each subject, and computational modeling based on an individual head model is performed to optimize electrode placement, individually focusing on the target side STN region. The sham group follows the same procedure but does not receive effective stimulation. The sham stimulation group receives only 30 seconds of fade-in/fade-out current at the beginning and end of the stimulation period to ensure blinding.

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200080
        • Recruiting
        • Shanghai General Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: the experimental group
real stimulation
Device: real transcranial temporal interference stimulation
tTIS was targeted at the bilateral STN, with stimulation delivered once daily for 20 minutes per session, for a total of five consecutive days.
Sham Comparator: the control group
sham stimulation
Device: sham transcranial temporal interference stimulation
The sham stimulation is administered using the same procedure as the real tTIS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of motor function in PD
Time Frame: Changes from baseline after 5 days of intervention (Day 5)
the scores of UPDRS III [OFF])
Changes from baseline after 5 days of intervention (Day 5)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of motor function in PD
Time Frame: Day 15, Day 35 （UPDRS III [OFF] ); Day 5, Day 15, Day 35 （UPDRS III [ON])
the scores of UPDRS III [OFF] and [ON]
Day 15, Day 35 （UPDRS III [OFF] ); Day 5, Day 15, Day 35 （UPDRS III [ON])
Changes of Motor Complications in PD
Time Frame: Day 5, Day 15, Day 35
the scores of UPDRS IV
Day 5, Day 15, Day 35
Assessment of changes in cognition
Time Frame: Day 5, Day 15, Day 35
the scores of MoCA
Day 5, Day 15, Day 35
Assessment of changes in anxiety
Time Frame: Day 5, Day 15, Day 35
the scores of HAMA
Day 5, Day 15, Day 35
Assessment of changes in depression
Time Frame: Day 5, Day 15, Day 35
the scores of HAMD
Day 5, Day 15, Day 35
Assessment of changes in sleep
Time Frame: Day 5, Day 15, Day 35
the scores of PSQI
Day 5, Day 15, Day 35
Assessment of changes in daytime sleepiness
Time Frame: Day 5, Day 15, Day 35
the scores of ESS
Day 5, Day 15, Day 35
Assessment of changes in RBD
Time Frame: Day 5, Day 15, Day 35
the scores of RBDSQ
Day 5, Day 15, Day 35
Assessment of changes in RLS
Time Frame: Day 5, Day 15, Day 35
the scores of IRLSRS
Day 5, Day 15, Day 35
Assessment of changes in Non-Motor Aspects of Experiences of Daily Living
Time Frame: Day 5, Day 15, Day 35
the scores of UPDRS I
Day 5, Day 15, Day 35
Assessment of changes in Motor Aspects of Experiences of Daily Living
Time Frame: Time Frame: Day 5, Day 15, Day 35
the scores of UPDRS II
Time Frame: Day 5, Day 15, Day 35

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changs of brain connectivity in the PD brain
Time Frame: After 5 days of intervention relative to baseline
functional magnetic resonance imaging (fMRI)
After 5 days of intervention relative to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

May 17, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shanghai1st-2026-tTIS
  • No. 02.06.02.26.19 (Other Grant/Funding Number: Basic and Clinical Collaborative Research Program of Shanghai General Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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