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

N/AEnrolling By InvitationNCT06931483

Yanghua Tian40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

Transcranial temporal interference stimulation (tTIS)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 transcranial temporal interference stimulation (tTIS)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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Anhui Medical University

Hefei, Anhui, China

Outcomes

Primary Outcomes

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

To assess the motor symptoms, participants completed the official Chinese version of MDS-UPDRS.The MDS-UPDRS-III includes 33 items, with scores ranging from 0 to 132. The subscores of MDS-UPDRS-III, including (1) rigidity (item 3.3), (2) bradykinesia (items 3.2, 3.4, 3.8, and 3.14), (3) tremor (items 3.15-3.18), and (4) axial signs (items 3.9-3.13), were also used as the secondary outcomes in the following analyses.

Time frame: On intervention Day 1, Day 10 and 1-month follow-up.

Secondary Outcomes

emotional symptoms assessed by the HAMA

The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.

Time frame: on intervention Day 1, Day 10 and 1-month follow-up

emotional symptoms assessed by the HAMD

The HAMD is a clinic ian-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.

Time frame: On intervention Day 1, Day 10 and 1-month follow-up.

Data from ClinicalTrials.gov

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