The Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) Targeting the Right Globus Pallidus Internus (GPi) for Motor Symptoms in Patients With PD

NCT ID: NCT06931483

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-12-31

Brief Summary

To demonstrate that intervention targeting the right globus pallidus internus (GPi) using transcranial temporal interference stimulation can improve motor symptoms in patients with Parkinson's disease.

Detailed Description

Each of patients received either 30-minute or sham tTIS of the right GPi. Before and immediately after the stimulation, participants completed the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III) in the "medication-on" state to assess the motor symptoms. MDS-UPDRS, HAMA and HAMD were assessed on intervention Day 1, Day 10 and 1-month follow-up and clinical efficacy was evaluated by comparing the scale scores before and after the intervention.

Conditions

Temporal Interference Stimulation; Parkinson's Disease; the Right Globus Pallidus Internus; Motor Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

real stimulation

Participants will receive active tTIS for 10 days.

Group Type: ACTIVE_COMPARATOR

Transcranial temporal interference stimulation (tTIS)

Intervention Type: DEVICE

The total stimulation duration was 30 minutes, including a 30-second current ramp-up at the beginning and a 30-second ramp-down at the end.

sham stimulation

Participants will receive sham tTIS for 10 days.

Group Type: SHAM_COMPARATOR

Sham transcranial temporal interference stimulation (tTIS)

Intervention Type: DEVICE

Sham stimulation had only 30 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation, respectively, to simulate the sensation of actual stimulation.

Interventions

Transcranial temporal interference stimulation (tTIS)

The total stimulation duration was 30 minutes, including a 30-second current ramp-up at the beginning and a 30-second ramp-down at the end.

Intervention Type: DEVICE

Sham transcranial temporal interference stimulation (tTIS)

Sham stimulation had only 30 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation, respectively, to simulate the sensation of actual stimulation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Meeting the diagnostic criteria for Parkinson's disease in China (2016 version), diagnosed as PD by two neurologists;

2. Hoehn-Yahr stage 1.5-4;

3. Age > 50 years old;

4. No signs of moderate to severe depression: Beck Depression Inventory-II (BDI-II) score < 20;

5. No signs of dementia: Mini-Mental State Examination (MMSE) score > 21;

6. No change in medication regimen in the four weeks prior to enrollment;

7. Right-handed.

Exclusion Criteria

1. History of other neuropsychiatric disorders;

2. History of alcohol or drug abuse;

3. Previous history of TMS or traditional TES treatment;

4. Presence of non-MRI compatible metal implants in the body, such as deep brain stimulation devices, pacemakers or stents.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yanghua Tian

OTHER

Sponsor Role: lead

Responsible Party

Yanghua Tian

Vice President of Anhui Medical University

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Anhui Medical University

Hefei, Anhui, China

Countries

China

Other Identifiers

AHMU-tTIS-PD

Identifier Type: -

Identifier Source: org_study_id