Motor Symptoms, Parkinson's Disease, Temporal Interference Stimulation, the Right Globus Pallidus Internus
Conditions
Keywords
temporal interference stimulation, Parkinson's Disease, motor symptoms, the right globus pallidus internus
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.
Interventions
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.
DEVICESham 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.
Sponsors
Yanghua Tian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | On intervention Day 1, Day 10 and 1-month follow-up. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| emotional symptoms assessed by the HAMA | on intervention Day 1, Day 10 and 1-month follow-up | 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. |
| emotional symptoms assessed by the HAMD | On intervention Day 1, Day 10 and 1-month follow-up. | 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. |
Countries
China
Outcome results
None listed