Non-invasive brain stimulation and rehabilitation training

JRCT ID: jRCTs042230011

Registered date:20/04/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Neurological diseases
• Date of first enrollment: 12/05/2023
• Target sample size: 240
• Study type: Interventional

Intervention(s)

Gait practice is performed while applying electrical stimulation such as tDCS (transcranial direct current stimulation) and tACS (transcranial alternating current stimulation).
Stimulating electrodes are placed in the cerebellar
brainstem, primary motor cortex lower extremity region (M1), and supplemental motor cortex, based on the constraint that the brain region involved in locomotion control is reachable by non-invasive electrical stimulation. The stimulation site varies depending on the disease.
The stimulus is -1-+1mA or -2- in accordance with the patient's individual gait cycle by the trigger from the pressure sensor at the timing of initial placement of the heel on the affected side during the period when the affected side touches the ground (stance phase) in the gait cycle. A weak current of +2mA is induced in one cycle of the sine wave.
For the optimal frequency of tACS, the numerical value determined as the gait frequency in the best gait state during the pre-evaluation is used. Depending on the disease, functional electrical stimulation is also performed at the same time.
Perform 4 sets of 4-5 minutes of natural gait or treadmill gait while stimulating.

Outcome(s)

• Primary Outcome: Comparison of gait function (gait speed and gait variability) between brain stimulation and sham stimulation interventions

Secondary Outcome

1.MDS-Unified Parkinson's Disease Rating Scale
2.Quantitative values of motor cortex excitability using TMS and surface electromyography
3.Correlation of functional connectivity between regions of the movement-related network using resting-state fMRI
4.Body movement measurement value
5.Electrophysiological assessment

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

1.Patients with established diagnosis of Parkinson's disease and Parkinson's syndrome (progressive supranuclear palsy, basal ganglia cortical degeneration, dementia with Lewy bodies, multiple system atrophy, cerebrovascular parkinsonism, normal pressure hydrocephalus, etc.), corticospinal tract disorder (stroke, encephalitis, etc.) and cerebellar ataxia (spinocerebellar degeneration, etc.) by the Department of Neurology
2.Age: 40-90 years old
3. Persons who can walk on the floor or treadmill using free hands or handrails
4.Patients who have obtained written consent for
participation in this study from the patients themselves or their surrogates

Exclude criteria

1.History or complication of other neuropsychiatric disorders
2. If you have metal such as a clip in your skull
3. Have a cardiac pacemaker
4. Has a history of epilepsy
5.History of limb joint or spine surgery
6. Cardiovascular and respiratory diseases such as myocardial infarction, angina pectoris, hypertension, deep vein thrombosis, chronic respiratory failure, etc. and at risk for exercise
7. Having metals in the body that cannot be confirmed as non-magnetic, such as nerve stimulators, aneurysm clips, insulin pumps, stents, intraocular metals, etc.
8. If you have severe hearing impairment and are unable to communicate
9. Pregnant women, those who may be pregnant
10.In addition, if the researcher or co-investigator judges it to be inappropriate

Related Information

• Primary Sponsor: Ueki Yoshino