Transcranial Stimulation in Motor Stroke Rehabilitation

University of Turin

Status: Completed

Conditions: Stroke

Treatments: Device: Sham; Device: tDCS; Device: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT02525393

CEI 339

Details and patient eligibility

About

Patients were randomized in 3 groups: two intervent groups and a control group. The first group received two weeks of daily session of repetitive Transcranial Magnetic Stimulation (rTMS, 10 sessions) and, at least 6 months after, two weeks of daily transcranial Direct Current Stimulation (tDCS, 10 sessions); the second group received 10 daily session of tDCS and, after at least 6 months, 10 sessions of rTMS; the control group received 10 daily session of sham tDCS.

Physiatric evaluations (ARAT scale), neuropsychological assessment and ERP (P300) were performed before (1 week) and after (1 week) the end of each treatment. Furthermore, all patients underwent follow-up neuropsychological assessment 6 months after the end of each stimulation period and follow-up physiatric evaluation at 3 and 6 months after the end of each stimulation period.

Enrollment: 34 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ischemic or hemorrhagic stroke (> 6 months from the accident)

Exclusion criteria

• general cognitive impairment (Mini Mental State Examination < 25), severe functional disability (Barthel Index < 45),
• psychiatric disorders,
• degenerative neurological disorders,
• epilepsy,
• severe medical conditions,
• having been implanted a drug infusion system, spinal/brain-stimulator, or endovascular coil

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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34 participants in 3 patient groups

tDCS+rTMS

Experimental group

Description:

Stroke patients were treated with an initial two weeks of transcranial direct current stimulation and after six months with two weeks of repetitive transcranial magnetic stimulation.

Treatment:

Device: rTMS

Device: tDCS

rTMS+tDCS

Experimental group

Description:

Stroke patients were treated with an initial two weeks of repetitive transcranial magnetic stimulation and after six months with two weeks of transcranial direct current stimulation.

Treatment:

Device: rTMS

Device: tDCS

Sham stimulation

Sham Comparator group

Description:

Stroke patients were treated with two weeks of sham transcranial direct current stimulation.

Treatment:

Device: Sham