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

Yanghua Tian

Status: Invitation-only

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

Treatments: Device: Transcranial temporal interference stimulation (tTIS); Device: Sham transcranial temporal interference stimulation (tTIS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06931483

AHMU-tTIS-PD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

real stimulation

Active Comparator group

Description:

Participants will receive active tTIS for 10 days.

Treatment:

Device: Transcranial temporal interference stimulation (tTIS)

sham stimulation

Sham Comparator group

Description:

Participants will receive sham tTIS for 10 days.

Treatment:

Device: Sham transcranial temporal interference stimulation (tTIS)