HF-rTMS Primed Balance Training on Corticomotor Excitability, Balance, and Gait in Parkinson's
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorChung Shan Medical University
About this trial
This study aims to investigate the effects of repeated transcranial magnetic stimulation combined with modified otago exercise program balance training intervention on motor cortex excitability, balance, and gait performance in patients with Parkinson's disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with idiopathic PD
Aged between 40-80 years
Stable on antiparkinsonian medication ( > 3 months)
H&Y I-III
Disqualifiers
Neurological diseases other than PD
Severe musculoskeletal, cardiopulmonary disorders
MMSE < 24
Contraindications for TMS
Trial design
Design model
Parallel
Treatments tested in this trial
high-frequency repetitive transcranial magnetic stimulation
DeviceA painless, non-invasive, and well-tolerated non-pharmacological treatment method-Repetitive Transcranial Magnetic Stimulation (rTMS)-delivers repeated and systematic magnetic field stimulation to specific brain regions through a stimulation coil placed on the scalp. These repeated magnetic pulses not only alter the excitability of the targeted area but also affect anatomically connected brain regions. The parameters are as follows: Frequency: 10 Hz; Intensity: 90% RMT; Duration: 4 seconds; Rest: 26 seconds; Trains: 25 times; Pulses: 1000\*2; Total time: 25 minutes.
Sham rTMS
DeviceIn this study, the sham stimulation group was designed based on previous related research and expert recommendations. Participants in this group will receive 20% of the stimulation intensity used in the treatment group, which is significantly lower than the treatment group's 90%, ensuring a safe and humane experimental design. The parameters are as follows: Frequency: 10 Hz; Intensity: 20% RMT; Duration: 4 seconds; Rest: 26 seconds; Trains: 25 times; Pulses: 1000\*2; Total time: 25 minutes.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: High-frequency rTMS + balance trainingExperimental treatment 1 intervention
Group B: Sham rTMS + balance trainingSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Corticospinal inhibition : Cortical silent period (CSP) (ms)
Cortical silent period (CSP) measured by Transcranial Magnetic Stimulation (TMS), with higher ms indicating stronger corticospinal inhibitory effect
Time frame
Baseline, week 5 and follow-up 1 month2
Intracortical inhibition : Short-interval intracortical inhibition (SICI) (%)
Short-interval intracortical inhibition (SICI) measured by Transcranial Magnetic Stimulation (TMS), with higher percentage indicating stronger intracortical inhibitory effect
Time frame
Baseline, week 5 and follow-up 1 month3
Mini-Balance Evaluation Systems Test (Mini-BESTest)
Mini-Balance Evaluation Systems Test (Mini-BESTest) is used to assess balance performance. Total scores range from 0 to 28, with higher scores indicating better balance and functional mobility.
Time frame
Baseline, week 5 and follow-up 1 month4
Falls Efficacy Scale-International (FES-I)
Falls Efficacy Scale-International (FES-I) is used to assess confidence in balance. Total scores range from 16 to 64, with higher scores indicating more balanced confidence
Time frame
Baseline, week 5 and follow-up 1 monthSecondary outcomes
1
Gait speed (m/s) measured by GAITRite
Time frame
Baseline, week 5 and follow-up 1 month2
Step length (m) measured by GAITRite
Time frame
Baseline, week 5 and follow-up 1 month3
Movement Disorder Society-Unified Parkinson's Disease Rating Scale, Part III: Motor Examination (MDS-UPDRS-III)
MDS-UPDRS-III is used to assess motor symptoms in patients with Parkinson's disease. Total scores range from 0 to 132, with higher scores indicating more severe motor symptoms.
Time frame
Baseline, week 5 and follow-up 1 monthLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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