Transcranial Stimulation in Motor Stroke Rehabilitation

August 13, 2015 updated by: Federico Dagata, University of Turin, Italy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Turin, Italy, 10126
        • AOU Città della Salute e della Scienza

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS+rTMS
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.
Device: tDCS
Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.
Other Names:
  • HDC Stim device Newronica
Device: rTMS
Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.
Other Names:
  • PowerMAG 100 MAG&More
Experimental: rTMS+tDCS
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.
Device: tDCS
Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.
Other Names:
  • HDC Stim device Newronica
Device: rTMS
Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.
Other Names:
  • PowerMAG 100 MAG&More
Sham Comparator: Sham stimulation
Stroke patients were treated with two weeks of sham transcranial direct current stimulation.
Device: Sham
Stroke sham stimulation performed with the aid of a transcranial electrical stimulation device.
Other Names:
  • HDC Stim device Newronica

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from the baseline ARAT (measures Grasp, Grip, Pinch, Gross Movement)
Time Frame: Baseline; 1 month; 3 months; 6 months; 6 months and 1 week; 7 months; 9 months; 12 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P300 (latency)
Time Frame: Baseline; 1 month; 6 months and 1 week; 7 months

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
Cognition (standardized neuropsychological assessment)
Time Frame: Baseline; 1 month; 6 months; 6 months and 1 week; 7 months; 12 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turin, Italy

Investigators

  • Principal Investigator: Federico D'Agata, PhD, University of Turin, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 11, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 17, 2015

Study Record Updates

Last Update Posted (Estimate)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI 339

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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