Effects of cerebellar transcranial direct current stimulation on upper limb after stroke

JRCT ID: jRCTs042200078

Registered date:17/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cerebrovascular disease
• Date of first enrollment: 17/12/2020
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Cerebellar tDCS combined with intensive training of upper limb

Outcome(s)

• Primary Outcome: Action research arm test

Secondary Outcome

1. Fugl-Meyer Assessment upper extremity
2. Motor activity log-14
3. Cerebellar brain inhibition
4. Motor evoked potential
5. MRI

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1. Written informed consent
2. First-ever unilateral supratentorial ischemic or hemorrhagic stroke
3. More than 6 months after the onset
4. Upper-limb hemiplegia (ARAT: Action Research Arm Test >=10, <=51)
5. Independent walking ability (FIM: Functional Independence Measure - Locomotion >=6)

Exclude criteria

1. Unconsciousness or severe aphasia
2. Unable to perform tasks due to severe higher brain dysfunction or psychiatric disorders
3. Cognitive impairment (MMSE: Mini-mental State Examination < 24)
4. Diagnosis of neurological disorders excluding stroke
5. Contraindications to tDCS, TMS, or MRI (i.e., having any metalic implants such as cardiac pacemaker, cardiac pacing leads or surgical clips, history of seizure or epilepsy, severe medical conditions, with pregnancy or during lactation)

Related Information

• Primary Sponsor: Otaka Yohei