The Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) Targeting the Right Globus Pallidus Internus (GPi) for Motor Symptoms in Patients With PD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial temporal interference stimulation (tTIS), Sham transcranial temporal interference stimulation (tTIS).
- Who it may be relevant to
- Registry conditions: Temporal Interference Stimulation, Parkinson's Disease, the Right Globus Pallidus Internus, Motor Symptoms. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
Interventions
- Device 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. - 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.
Primary outcome measures
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [Time frame: On intervention Day 1, Day 10 and 1-month follow-up.]
Secondary outcome measures (2)
- emotional symptoms assessed by the HAMA [Time frame: on intervention Day 1, Day 10 and 1-month follow-up]
- emotional symptoms assessed by the HAMD [Time frame: On intervention Day 1, Day 10 and 1-month follow-up.]
Eligibility criteria
Inclusion criteria
- Meeting the diagnostic criteria for Parkinson's disease in China (2016 version), diagnosed as PD by two neurologists;
- Hoehn-Yahr stage 1.5-4;
- Age > 50 years old;
- No signs of moderate to severe depression: Beck Depression Inventory-II (BDI-II) score < 20;
- No signs of dementia: Mini-Mental State Examination (MMSE) score > 21;
- No change in medication regimen in the four weeks prior to enrollment;
- Right-handed.
Exclusion criteria
- History of other neuropsychiatric disorders;
- History of alcohol or drug abuse;
- Previous history of TMS or traditional TES treatment;
- Presence of non-MRI compatible metal implants in the body, such as deep brain stimulation devices, pacemakers or stents.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Anhui Medical University — Hefei
Identifiers
NCT: NCT06931483 · AHMU-tTIS-PD