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Transcranial Stimulation in Motor Stroke Rehabilitation

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
tDCS
rTMS
Sham
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Non Invasive Brain Stimulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • AOU Città della Salute e della Scienza

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

tDCS+rTMS

rTMS+tDCS

Sham stimulation

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 11, 2015
Last Updated
August 13, 2015
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT02525393
Brief Title
Transcranial Stimulation in Motor Stroke Rehabilitation
Official Title
Safety and Efficacy of Non Invasive Transcranial Brain Stimulation in Motor Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rehabilitation, Non Invasive Brain Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS+rTMS
Arm Type
Experimental
Arm 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.
Arm Title
rTMS+tDCS
Arm Type
Experimental
Arm 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.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Stroke patients were treated with two weeks of sham transcranial direct current stimulation.
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
HDC Stim device Newronica
Intervention Description
Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.
Intervention Type
Device
Intervention Name(s)
rTMS
Other Intervention Name(s)
PowerMAG 100 MAG&More
Intervention Description
Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.
Intervention Type
Device
Intervention Name(s)
Sham
Other Intervention Name(s)
HDC Stim device Newronica
Intervention Description
Stroke sham stimulation performed with the aid of a transcranial electrical stimulation device.
Primary Outcome Measure Information:
Title
Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement)
Description
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.
Time Frame
Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months
Secondary Outcome Measure Information:
Title
P300 (latency)
Description
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.
Time Frame
Baseline; 1 month; 6 months and 1 week; 7 months
Title
Cognition (standardized neuropsychological assessment)
Description
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.
Time Frame
Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Federico D'Agata, PhD
Organizational Affiliation
University of Turin, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
AOU Città della Salute e della Scienza
City
Turin
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

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Transcranial Stimulation in Motor Stroke Rehabilitation

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