STN-tTIS With Different Intervention Intervals Versus Standard Medical Treatment for Parkinson's Disease

NCT07774312 | Recruiting

• 1 other identifier: 2026380
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the efficacy and safety of different Intervention Intervals of subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) in patients with Parkinson disease. Previous studies suggest that STN-tTIS may improve motor symptoms in people with Parkinson disease. However, most previous studies evaluated only one stimulation session. It remains unclear how often STN-tTIS should be administered during a repeated treatment course and whether shorter intervention intervals stimulation produces greater or longer-lasting improvement without increasing adverse events. The main questions this study aims to answer are:

1. 1.Does STN-tTIS administered five times weekly improve motor symptoms more than standard medication treatment alone at the end of the 2-week treatment period?
2. 2.Do once-weekly, twice-weekly, and five-times-weekly STN-tTIS produce different changes in motor symptoms?
3. 3.Does the STN-tTIS intervention intervals influence how long its effects persist after treatment?
4. 4.Do the different intervention intervals have different effects on non-motor symptoms, quality of life, cognitive function, and safety?

Conditions

Parkinson's Disease (PD)

Keywords

Subthalamic nucleus; Transcranial Temporal Interference Stimulation; Intervention Intervals

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in MDS-UPDRS Part III Total Score at the End of the Intervention Period

  The Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS Part III) is used to assess the severity of motor symptoms in Parkinson disease. The total score ranges from 0 to 132, with higher scores indicating greater motor impairment. The primary outcome is the change in MDS-UPDRS Part III total score from baseline to Day 12, corresponding to the end of the 2-week intervention period. Assessments are performed during the ON medication state. A greater reduction from baseline indicates greater improvement in motor symptoms.

  Baseline to Day 12

Secondary Outcomes (6)

• Change From Baseline in MDS-UPDRS Part I Score

  Baseline to Day 12 and Day 27

• Change From Baseline in MDS-UPDRS Part II Score

  Baseline to Day 12 and Day 27

• Change From Baseline in MDS-UPDRS Part IV Score

  Baseline to Day 12 and Day 27

• Change From Baseline in Non-Motor Symptoms Scale (NMSS) Score

  Baseline to Day 12 and Day 27

• Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Score

  Baseline to Day 12 and Day 27

Other Outcomes (4)

• Change in Remotely Assessed MDS-UPDRS Part III Score

  Day 1 to Day 27

• Change in Smartwatch-Derived Tremor Duration

  Baseline to Day 27

• Change in Home-Based Active Motor Assessment Measures

  Baseline to Day 27

Study Arms (4)

STN-tTIS Once Weekly

EXPERIMENTAL

Participants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) once weekly for 2 weeks in addition to stable antiparkinsonian medication.

Device: STN-tTIS Once Weekly; Drug: Standard Antiparkinsonian Medication

STN-tTIS Twice Weekly

EXPERIMENTAL

Participants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) twice weekly for 2 weeks in addition to stable antiparkinsonian medication.

Device: STN-tTIS Twice Weekly; Drug: Standard Antiparkinsonian Medication

STN-tTIS Five Times Weekly

EXPERIMENTAL

Participants receive STN-targeted transcranial temporal interference stimulation (STN-tTIS) five times weekly for 2 weeks in addition to stable antiparkinsonian medication.

Device: STN-tTIS Five Times Weekly; Drug: Standard Antiparkinsonian Medication

Standard Medical Therapy Alone

ACTIVE COMPARATOR

Participants continue their stable antiparkinsonian medication regimen for 2 weeks without additional STN-tTIS.

Drug: Standard Antiparkinsonian Medication

Interventions

STN-tTIS Once Weekly DEVICE

Participants receive subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) once weekly for 2 weeks. Each stimulation session lasts 20 minutes. Two high-frequency alternating currents at 2000 Hz and 2130 Hz are delivered through two pairs of scalp electrodes, generating a 130-Hz temporal interference envelope targeting the subthalamic nucleus. Stable antiparkinsonian medication is maintained throughout the intervention period.

Also known as: Transcranial Temporal Interference Stimulation

STN-tTIS Once Weekly

STN-tTIS Twice Weekly DEVICE

Participants receive subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) twice weekly for 2 weeks. Each stimulation session lasts 20 minutes. Two high-frequency alternating currents at 2000 Hz and 2130 Hz are delivered through two pairs of scalp electrodes, generating a 130-Hz temporal interference envelope targeting the subthalamic nucleus. Stable antiparkinsonian medication is maintained throughout the intervention period.

Also known as: Transcranial Temporal Interference Stimulation

STN-tTIS Twice Weekly

STN-tTIS Five Times Weekly DEVICE

Participants receive subthalamic nucleus-targeted transcranial temporal interference stimulation (STN-tTIS) five times weekly for 2 weeks. Each stimulation session lasts 20 minutes. Two high-frequency alternating currents at 2000 Hz and 2130 Hz are delivered through two pairs of scalp electrodes, generating a 130-Hz temporal interference envelope targeting the subthalamic nucleus. Stable antiparkinsonian medication is maintained throughout the intervention period.

Also known as: Transcranial Temporal Interference Stimulation

STN-tTIS Five Times Weekly

Standard Antiparkinsonian Medication DRUG

Participants continue their stable antiparkinsonian medication regimen throughout the 2-week study intervention period. No additional STN-tTIS is administered.

STN-tTIS Five Times Weekly; STN-tTIS Once Weekly; STN-tTIS Twice Weekly; Standard Medical Therapy Alone

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50-85 years, male or female.
• Diagnosed with idiopathic Parkinson disease (PD) in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Parkinson's Disease (4th Edition), with a confirmed diagnosis for at least 6 months and a stable condition, defined as no significant deterioration or major medication adjustment within the past month.
• Receiving stable doses of antiparkinsonian medication (e.g., levodopa or dopamine agonists) and willing to maintain the medication regimen during the study.
• Hoehn and Yahr stage 1-3 in the medication ON state.
• Baseline MDS-UPDRS Part III total score ≥20 in the medication ON state.
• No history of non-invasive neuromodulation therapy, or discontinuation of such therapy for at least 3 months before enrollment if previously received.
• Normal cognitive function (MoCA score ≥24) and able to cooperate with tTIS intervention, clinical scale assessments, and basic smartphone- and smartwatch-assisted home-based motor self-assessments.
• Able and willing to provide written informed consent and complete all required study procedures and follow-up assessments.

You may not qualify if:

• Other neurological disorders that may affect motor or cognitive function.
• Contraindications to magnetic resonance imaging (MRI), such as claustrophobia.
• History of taking antipsychotics, antidepressants, or other medications affecting dopamine levels.
• Psychiatric disorders (e.g., depression or schizophrenia), substance abuse, or alcohol dependence.
• Implanted medical devices (e.g., pacemaker or defibrillator), metal implants in the cranium or spine, a personal or family history of epilepsy, or severe skull defects.
• Previous deep brain stimulation (DBS) or other intracranial implantation surgery, or participation in another Parkinson disease clinical trial within the past 3 months.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

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

Central Study Contacts

Chencheng Zhang, MD, PHD

CONTACT

13381827024; i@cchang.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1:1:1 ratio to one of three STN-tTIS groups with different intervention intervals or to a control group receiving standard medical therapy alone. Each participant will remain in the assigned group throughout the study.

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 19, 2026
• Study Start: July 27, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): April 15, 2027
• Last Updated: August 21, 2026

Record last verified: 2026-07

Locations

CN (1)