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

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. 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. Do once-weekly, twice-weekly, and five-times-weekly STN-tTIS produce different changes in motor symptoms?
3. Does the STN-tTIS intervention intervals influence how long its effects persist after treatment?
4. Do the different intervention intervals have different effects on non-motor symptoms, quality of life, cognitive function, and safety?

Participants will be randomly assigned to receive STN-tTIS once weekly, twice weekly, or five times weekly for 2 weeks, or to continue standard antiparkinsonian medication without additional stimulation. All participants will maintain a stable medication regimen during the study. Their motor and non-motor symptoms will be assessed during the treatment period and during a subsequent 2-week follow-up period.

Conditions

• Parkinson's Disease (PD)

Interventions

DEVICE

STN-tTIS Once Weekly

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.

DEVICE

STN-tTIS Twice Weekly

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.

DEVICE

STN-tTIS Five Times Weekly

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.

DRUG

Standard Antiparkinsonian Medication

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

Sponsors & Collaborators

• Ruijin Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-27

Primary Completion

2027-03-15

Completion

2027-04-15

Countries

• China

Study Locations