Accelerated Temporal Interference Stimulation on Bilateral Subthalamic Nucleus for Parkinson's Disease and Secondary Parkinson's Syndrome

Ke Dong, MD

Status: Enrolling

Conditions: Parkinson Disease, Secondary; Parkinson Disease

Treatments: Device: Temporal Interference Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07568067

Nos.82372556

Details and patient eligibility

About

This clinical trial will evaluate the efficacy of accelerated Temporal Interference Stimulation (TIS) as a therapeutic intervention for individuals diagnosed with Parkinson's disease or secondary Parkinson's syndrome. Accelerated TIS will be delivered targeting the bilateral subthalamic nuclei of the brain. The primary objective is to assess whether accelerated TIS yields measurable improvements in motor performance and verbal speech function among enrolled subjects. Functional magnetic resonance imaging (fMRI) will be adopted as an auxiliary imaging modality to objectively characterize underlying cerebral functional alterations induced by accelerated TIS intervention. The core scientific research questions to be addressed in this trial are listed as follows:

• Will accelerated TIS administered to the bilateral subthalamic nuclei produce significant improvements in motor function and speech performance among enrolled subjects with Parkinson-related disorders?
• What quantitative and qualitative modifications in cerebral functional activity will be detected via fMRI after standardized accelerated TIS intervention administration?

Investigators will implement a four-arm parallel controlled comparative design for all enrolled eligible subjects. All confirmed Parkinson's disease patients will undergo standardized random grouping and be allocated into two independent research arms. Subjects in the experimental arm will receive continuous, standardized accelerated TIS intervention targeting bilateral subthalamic nuclei. Subjects in the control arm will receive matched sham stimulation intervention. Sham stimulation adopts identical operation procedures, equipment wearing mode and on-site operating environment as formal accelerated TIS, with no valid neuromodulation therapeutic effect generated. Identical random grouping, intervention arrangement and controlled research design will be fully implemented in eligible subjects diagnosed with secondary Parkinson's syndrome. Rigorous controlled grouping design will ensure objective, verifiable data support for verifying the actual intervention efficacy of accelerated TIS on motor dysfunction and speech impairment in Parkinson-related patients.

All enrolled subjects will complete the following standardized trial procedures in full compliance with the trial protocol:

• Receive continuous targeted intervention of either formal accelerated TIS or matched sham stimulation on bilateral subthalamic nuclei, with consecutive 5-day fixed-course administration in strict accordance with trial operating specifications
• Complete unified fMRI brain scanning examinations and standardized motor function as well as speech function quantitative evaluation assessments at two fixed time nodes, including the baseline time point before intervention initiation and the follow-up time point after all intervention courses are completed
• Truthfully record all adverse reactions and abnormal physical discomfort symptoms that occur throughout the whole intervention and follow-up observation cycle in standardized adverse event registration forms

Enrollment: 60 estimated patients

Sex: All

Ages: Under 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Confirmed diagnosis of idiopathic Parkinson's disease or secondary parkinson's syndrome ; Hoehn-Yahr stage 1.5-3.
2. Ability to walk independently.
3. Ability to follow instructions, with no cognitive impairment.
4. Patient and their family agree to cooperate with treatment and provide written informed consent.

Exclusion criteria

1. Claustrophobia or presence of metallic implants precluding MRI examination and evaluation.
2. Severe dysfunction of vital organs including heart, lung, liver, kidney, etc.
3. Complicated with other neurological diseases such as cerebral infarction.
4. Presence of mental illness, severe depression, anxiety, etc., which may affect the accuracy of study results.
5. History of deep brain stimulation (DBS) surgery.
6. Patients unable or unwilling to cooperate with scale assessments.
7. Aged over 80 years old.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 4 patient groups

Active Stimulation Group-Parkinson's disease

Experimental group

Description:

Participants diagnosed with Parkinson's disease in the active stimulation group will receive sequential bilateral subthalamic nucleus (STN) temporal interference electrical stimulation therapy twice daily, with each session lasting 40 minutes and a rest interval of at least 1 hour between treatments. The stimulation target is the bilateral subthalamic nucleus, with individualized electrode placement and current intensity determined via personalized modeling based on each patient's magnetic resonance imaging (MRI) data. The active stimulation uses two distinct high frequencies (2000 Hz and 2130 Hz) to generate a therapeutic interference field.

Treatment:

Device: Temporal Interference Stimulation

Device: Temporal Interference Stimulation

Sham Stimulation Group-Parkinson's disease

Sham Comparator group

Description:

Participants diagnosed with Parkinson's disease in the sham stimulation group will follow an identical stimulation protocol to the active stimulation group (twice daily, 40 minutes per session, bilateral STN targeting via personalized MRI modeling), except that two identical high frequencies (2000 Hz and 2000 Hz) are applied to eliminate the therapeutic interference effect, serving as a sham control condition.

Treatment:

Device: Temporal Interference Stimulation

Device: Temporal Interference Stimulation

Active Stimulation Group- secondary Parkinson's syndrome

Experimental group

Description:

Participants diagnosed with secondary Parkinson's syndrome in the active stimulation group will receive sequential bilateral subthalamic nucleus (STN) temporal interference electrical stimulation therapy twice daily, with each session lasting 40 minutes and a rest interval of at least 1 hour between treatments. The stimulation target is the bilateral subthalamic nucleus, with individualized electrode placement and current intensity determined via personalized modeling based on each patient's magnetic resonance imaging (MRI) data. The active stimulation uses two distinct high frequencies (2000 Hz and 2130 Hz) to generate a therapeutic interference field.

Treatment:

Device: Temporal Interference Stimulation

Device: Temporal Interference Stimulation

Sham Stimulation Group- secondary Parkinson's syndrome

Sham Comparator group

Description:

Participants diagnosed with secondary Parkinson's syndrome in the sham stimulation group will follow an identical stimulation protocol to the active stimulation group (twice daily, 40 minutes per session, bilateral STN targeting via personalized MRI modeling), except that two identical high frequencies (2000 Hz and 2000 Hz) are applied to eliminate the therapeutic interference effect, serving as a sham control condition.

Treatment:

Device: Temporal Interference Stimulation

Device: Temporal Interference Stimulation