Subthalamic Nucleus (STN) Targeted Transcranial Temporal Interference Stimulation (TIS) Treats Parkinson's Disease

NCT07361250 | Not Yet Recruiting DMC

• 1 other identifier: 202511129
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-center, prospective, double-blind, randomized controlled trial to evaluate the efficacy and safety of transcranial temporal interference stimulation targeting the subthalamic nucleus in patients with Parkinson's disease. It plans to enroll 20 eligible participants who will be randomly assigned in a 1:1 ratio to either the active TIS stimulation group or the sham stimulation group.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Temporal Interference Stimulation; Subthalamic Nucleus (STN)

Outcome Measures

Primary Outcomes (1)

• Change in Score on Part III (Motor Examination) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

  The motor function of patients was assessed using Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III), which has a total score range of 0 to 132. In this scale, a higher score indicates greater severity of motor symptoms and therefore a worse outcome, with 0 representing no impairment and 132 representing the most severe impairment. Changes in the score reflect the degree of improvement in motor function.

  Baseline (before treatment), immediately after the 1st（day1）, 5th（day3）, and 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.

Secondary Outcomes (9)

• MDS-UPDRS Scale Part I Non-Motor Function Score Changes

  Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.

• MDS-UPDRS Scale Part II: Activities of Daily Living Score Changes

  Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.

• MDS-UPDRS Scale Part IV: Motor Fluctuations, Dyskinesias, and Dystonia Score Changes

  Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.

• Change in Score on the 39-item Parkinson's Disease Questionnaire (PDQ-39)

  Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.

• Change in Score on the Hamilton Depression Rating Scale (HAMD)

  Baseline (before treatment), immediately after the 9th（day5） stimulation sessions (each session lasts for 30 min), and at the two-week and four-week follow-ups after the completion of treatment.

Other Outcomes (2)

• The incidence of SAE

  From the first stimulation session until the end of the study follow-up period (each stimulation session lasts for 30 minutes; total study duration including follow-up is 5 weeks). SAEs will be monitored and recorded continuously throughout this period.

• All-cause mortality

  1month after randomization

Study Arms (2)

Active TIS stimulation

EXPERIMENTAL

Participants in this group will receive transcranial temporal interference stimulation targeting the subthalamic nucleus using a frequency pair of 2000 Hz and 2130 Hz. Stimulation will be delivered twice daily at the same time for 30 minutes per session over five consecutive days（only once on the 5th day）. Stimulation intensity will be individually titrated starting from a low level and gradually increased to the maximum tolerable level. All treatments will be administered during the participant's medication "on" state.

Device: NervioX-1000

Sham stimulation

SHAM COMPARATOR

Participants in this group will receive sham stimulation using a frequency pair of 2000 Hz and 2000 Hz. Stimulation will be administered twice daily for 30 minutes per session over five consecutive days（only once on the 5th day） during the participant's medication "on" state, with current intensity individually titrated in the same manner as the active group. The sham protocol includes cutaneous sensation simulation during a 30-second ramp-up and ramp-down phase to maintain participant blinding, but does not generate an effective interference field in the deep brain target.

Device: NervioX-1000

Interventions

NervioX-1000 DEVICE

All participants will receive individualized T1-weighted MRI scans for computational modeling to determine optimized electrode placement and stimulation parameters for transcranial temporal interference stimulation targeting the subthalamic nucleus. The stimulation protocol is designed to generate a focal 130 Hz interference field in the target region while minimizing cortical activation. Parameters including electrode positions and current intensity are customized based on each participant's unique neuroanatomy to ensure precise and tailored neuromodulation.

Active TIS stimulation; Sham stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older, no gender restriction;

You may not qualify if:

• Disease duration ≥1 year, stable condition;
• Hoehn-Yahr stage between 1.5 and 3, with a stable dose of levodopa or other dopaminergic medications for at least 4 weeks, responsive to levodopa-like medications, and no changes to the treatment regimen during the trial;
• Good compliance, with the patient and family willing to participate in the clinical trial, voluntarily sign the informed consent form, attend regular treatments and follow-ups, and accurately complete evaluation tasks.
• Severe cognitive impairment, resulting in poor compliance due to dementia, and/or inability to sign the informed consent form;
• History of severe psychiatric disorders, patients with a Hamilton Depression Scale (HAMD) score \>24;
• History of taking antipsychotic drugs, antidepressants, or other medications that may affect dopamine levels;
• History of seizures within the last year or a family history of epilepsy;
• Unable to complete MRI scanning (e.g., due to claustrophobia, or having metal implants in the body);
• Patients with severe heart, liver, or kidney diseases, severe hypertension, and severe orthostatic hypotension that affect their health condition;
• Patients with severe diabetes or severe cardio-cerebrovascular diseases that affect their health condition;
• Diagnosed with malignant tumors;
• Contraindications for non-invasive electrical stimulation, such as intracranial active implants (regardless of whether they are turned on) or passive implants that may affect electrical stimulation treatment, those who have undergone stereotactic deep brain stimulation or neurotomy, or have had any surgical procedures within the last six months that the investigator believes may affect this trial;
• History of traumatic brain injury;
• Pregnant women or women planning to become pregnant;
• Subjects currently participating in other clinical trials or have participated in other clinical research within the last three months without reaching primary endpoints;

Sponsors & Collaborators

• Tang Zhouping: lead

Related Publications (3)

• Yang C, Xu Y, Du Y, Shen X, Li T, Chen N, Zhu Y, Li L, Huang L, Lu J, Qian Z, Wang Z, Zhou J, Ziemann U, Zhang C, Liu Y. Transcranial temporal interference subthalamic stimulation for treating motor symptoms in Parkinson's disease: A pilot study. Brain Stimul. 2024 Nov-Dec;17(6):1250-1252. doi: 10.1016/j.brs.2024.10.012. Epub 2024 Oct 30. No abstract available.

  PMID: 39486623 RESULT

• Violante IR, Alania K, Cassara AM, Neufeld E, Acerbo E, Carron R, Williamson A, Kurtin DL, Rhodes E, Hampshire A, Kuster N, Boyden ES, Pascual-Leone A, Grossman N. Non-invasive temporal interference electrical stimulation of the human hippocampus. Nat Neurosci. 2023 Nov;26(11):1994-2004. doi: 10.1038/s41593-023-01456-8. Epub 2023 Oct 19.

  PMID: 37857775 RESULT

• Grossman N, Bono D, Dedic N, Kodandaramaiah SB, Rudenko A, Suk HJ, Cassara AM, Neufeld E, Kuster N, Tsai LH, Pascual-Leone A, Boyden ES. Noninvasive Deep Brain Stimulation via Temporally Interfering Electric Fields. Cell. 2017 Jun 1;169(6):1029-1041.e16. doi: 10.1016/j.cell.2017.05.024.

  PMID: 28575667 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Zhouping Tang, PhD MD

  Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 450001

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhouping Tang

CONTACT

+86 13971616328; ddjtzp@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind trial where participants, investigators administering the intervention, and outcome assessors are blinded. Due to the operation of the Temporal Interference Stimulation device, only the instrument operator administering the experimental stimulation in this experiment is non-blinded. Identical stimulation procedures are used for both groups, with the sham group receiving a non-effective frequency pair.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: January 22, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 20, 2027
• Last Updated: January 22, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share