search
Back to results

Transcranial Stimulation and Motor Training in Stroke Rehabilitation (tDCS)

Primary Purpose

Stroke, Cerebral Infarction, Cerebrovascular Disorders

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Anodal tDCS
Motor Training
Sponsored by
University of Oxford
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring tDCS, Stroke, Functional MRI, Motor Learning

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 - 80 years.
  • Patients should be at least six months post first symptomatic stroke affecting motor function of the hand.

Exclusion Criteria:

  • Anyone who does not have adequate understanding of verbal and written information in English, sufficient to complete any of the safety screening forms.
  • Anyone who has a previous history of epilepsy, febrile convulsions as a child or recurrent fainting fits. Likewise, anyone who has a significant family history of epilepsy would be excluded as all these conditions carry a theoretical risk of increasing susceptibility to seizures.
  • Any person who has a history of drug abuse or a previous history of a neurological or psychiatric illness, or has a history of neurosurgical procedure is excluded as they may be at increased risk of epilepsy and data collected may be influenced by their condition.
  • Patients on some prescription medications such as anti-depressants may be excluded as they may be at an increased risk of seizures.
  • Anyone who is currently taking or who has taken anti-malarial treatment in the last 72 hours.
  • Pregnant women are excluded as a precaution as there is no data on the effect on maternal cranial stimulation on the fetus.
  • Any metallic implant in the neck, head, or eye and anyone with any implanted electrical devices would be excluded as there is a risk of heating with both TMS and TDCS stimulation.
  • Anyone with any metal implants or implantable device would be excluded as indicated by the MRI safety screening form. People who suffer with claustrophobia as they are unable to tolerate the scanner.
  • Patients who have had more than one stroke. Patients who have had a stroke will also be excluded if they have limited communication in the form of aphasia or a history of dementia.

Sites / Locations

  • Centre for Functional MRI of the Brain (FMRIB)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Anodal tDCS and Motor Training

Sham tDCS and Motor Training

Arm Description

Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere. The following parameters will be used: stimulation intensity of 1mA for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).

Participants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).

Outcomes

Primary Outcome Measures

Fugl Meyer Assessment of Motor Recovery following Stroke
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Wolf Motor Function Test
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Action Research Arm Test
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
9 Hole Peg Test
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.

Secondary Outcome Measures

Reaction Time Test
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Stroke Impact Scale
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.

Full Information

First Posted
August 4, 2011
Last Updated
June 19, 2012
Sponsor
University of Oxford
Collaborators
National Institute for Health Research, United Kingdom, The Dunhill Medical Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT01414582
Brief Title
Transcranial Stimulation and Motor Training in Stroke Rehabilitation
Acronym
tDCS
Official Title
Transcranial Direct Current Stimulation (tDCS) as a Potential Adjunct Intervention in Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oxford
Collaborators
National Institute for Health Research, United Kingdom, The Dunhill Medical Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to test whether repeated sessions of tDCS result in long-lasting improvements in motor function in patients with chronic stroke.
Detailed Description
Previous research that utilises single sessions of tDCS have demonstrated functional improvements; however, these improvements are usually short-lived, lasting less than one hour before the patient's performance returns to baseline. It has been suggested that repeated stimulation sessions are required to elicit long-lasting improvements. We aim to consider these details over the duration of this research, during which patients with chronic stroke will attend for 16 sessions over the course of 3 months. This research has important implications; previous studies suggest that such an approach has the potential to facilitate physical rehabilitation post-stroke and establish tDCS as a clinically viable rehabilitative tool. Recovery of motor skills may take many months to acquire and therefore strategies that have the potential to enhance acquisition of skill are of practical and scientific interest.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebral Infarction, Cerebrovascular Disorders, Brain Diseases
Keywords
tDCS, Stroke, Functional MRI, Motor Learning

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anodal tDCS and Motor Training
Arm Type
Experimental
Arm Description
Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere. The following parameters will be used: stimulation intensity of 1mA for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).
Arm Title
Sham tDCS and Motor Training
Arm Type
Sham Comparator
Arm Description
Participants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).
Intervention Type
Device
Intervention Name(s)
Anodal tDCS
Intervention Description
Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere. The following parameters will be used: stimulation intensity of 1mA for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).
Intervention Type
Other
Intervention Name(s)
Motor Training
Intervention Description
All participants will receive a standardised motor training intervention for the upper paretic limb
Primary Outcome Measure Information:
Title
Fugl Meyer Assessment of Motor Recovery following Stroke
Description
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Time Frame
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
Title
Wolf Motor Function Test
Description
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Time Frame
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
Title
Action Research Arm Test
Description
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Time Frame
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
Title
9 Hole Peg Test
Description
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Time Frame
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
Secondary Outcome Measure Information:
Title
Reaction Time Test
Description
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Time Frame
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.
Title
Stroke Impact Scale
Description
We are looking for a change in scores between the average of the 2 baseline session scores, and those collected during each follow-up session.
Time Frame
Assessed at 2 separate baseline sessions (at least 1 week apart), and then again immediately following the 9 day intervention (day 10), 1 week, 1 month and 3 months later.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study. Male or Female, aged 18 - 80 years. Patients should be at least six months post first symptomatic stroke affecting motor function of the hand. Exclusion Criteria: Anyone who does not have adequate understanding of verbal and written information in English, sufficient to complete any of the safety screening forms. Anyone who has a previous history of epilepsy, febrile convulsions as a child or recurrent fainting fits. Likewise, anyone who has a significant family history of epilepsy would be excluded as all these conditions carry a theoretical risk of increasing susceptibility to seizures. Any person who has a history of drug abuse or a previous history of a neurological or psychiatric illness, or has a history of neurosurgical procedure is excluded as they may be at increased risk of epilepsy and data collected may be influenced by their condition. Patients on some prescription medications such as anti-depressants may be excluded as they may be at an increased risk of seizures. Anyone who is currently taking or who has taken anti-malarial treatment in the last 72 hours. Pregnant women are excluded as a precaution as there is no data on the effect on maternal cranial stimulation on the fetus. Any metallic implant in the neck, head, or eye and anyone with any implanted electrical devices would be excluded as there is a risk of heating with both TMS and TDCS stimulation. Anyone with any metal implants or implantable device would be excluded as indicated by the MRI safety screening form. People who suffer with claustrophobia as they are unable to tolerate the scanner. Patients who have had more than one stroke. Patients who have had a stroke will also be excluded if they have limited communication in the form of aphasia or a history of dementia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heidi Johansen-Berg, Prof.
Phone
01865 222799
Email
heidi@fmrib.ox.ac.uk
Facility Information:
Facility Name
Centre for Functional MRI of the Brain (FMRIB)
City
Oxford
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Transcranial Stimulation and Motor Training in Stroke Rehabilitation

We'll reach out to this number within 24 hrs