Transcranial Stimulation in Motor Stroke Rehabilitation

Stroke Clinical Trial

Official title:

Safety and Efficacy of Non Invasive Transcranial Brain Stimulation in Motor Stroke Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525393
• Other study ID #: CEI 339
• Status: Completed
• Phase: N/A
• First received: August 11, 2015
• Last updated: August 13, 2015
• Start date: March 2012
• Est. completion date: July 2014

Study information

• Verified date: August 2015
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• tDCS
Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.
• rTMS
Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.
• Sham
Stroke sham stimulation performed with the aid of a transcranial electrical stimulation device.

Locations

Country	Name	City	State
Italy	AOU Città della Salute e della Scienza	Turin

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement)	Action Research Arm Test (ARAT) measures Grasp, Grip, Pinch, Gross Movement. Baseline is 1 week before first treatment; other time frame: 1 week after first treatment; 3 months after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 3 months follow-up after second treatment; 6 months follow-up after second treatment.	Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months	No
Secondary	P300 (latency)	The P300 (P3) wave is an event related potential (ERP) component elicited in the process of decision making.; Investigators measured the latency of the component 1 week before first treatment; 1 week after first treatment; 1 week before second treatment; 1 week after second treatment.	Baseline; 1 month; 6 months and 1 week; 7 months	No
Secondary	Cognition (standardized neuropsychological assessment)	The patients were evaluated by means of a standardized neuropsychological assessment consisting of a battery of cognitive tests involving the following domains: verbal short-term memory, visuospatial learning, working memory, verbal learning, attention and frontal executive functions, and general cognitive impairment.; The assessment was repeated 1 week before first treatment; 1 week after first treatment; 6 months follow-up after first treatment; 1 week before second treatment; 1 week after second treatment; 6 months follow-up after second treatment.	Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months	No