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Transcranial Stimulation and Motor Training in Stroke Rehabilitation (tDCS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by University of Oxford.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01414582
First Posted: August 11, 2011
Last Update Posted: June 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute for Health Research, United Kingdom
The Dunhill Medical Trust
Information provided by:
University of Oxford
  Purpose
This study aims to test whether repeated sessions of tDCS result in long-lasting improvements in motor function in patients with chronic stroke.

Condition Intervention Phase
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Device: Anodal tDCS Other: Motor Training Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) as a Potential Adjunct Intervention in Stroke Rehabilitation

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Fugl Meyer Assessment of Motor Recovery following Stroke [ 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. ]
    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 [ 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. ]
    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 [ 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. ]
    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 [ 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. ]
    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 [ 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. ]
    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 [ 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. ]
    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.


Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anodal tDCS and Motor Training
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).
Device: Anodal tDCS
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).
Other: Motor Training
All participants will receive a standardised motor training intervention for the upper paretic limb
Sham Comparator: Sham tDCS and Motor Training
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).
Other: Motor Training
All participants will receive a standardised motor training intervention for the upper paretic limb

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414582


Contacts
Contact: Heidi Johansen-Berg, Prof. 01865 222799 heidi@fmrib.ox.ac.uk

Locations
United Kingdom
Centre for Functional MRI of the Brain (FMRIB) Recruiting
Oxford, United Kingdom
Sponsors and Collaborators
University of Oxford
National Institute for Health Research, United Kingdom
The Dunhill Medical Trust
  More Information

Responsible Party: Heather House, University of Oxford Research Services
ClinicalTrials.gov Identifier: NCT01414582     History of Changes
Other Study ID Numbers: 10/H0604/98
First Submitted: August 4, 2011
First Posted: August 11, 2011
Last Update Posted: June 20, 2012
Last Verified: June 2012

Keywords provided by University of Oxford:
tDCS
Stroke
Functional MRI
Motor Learning

Additional relevant MeSH terms:
Stroke
Infarction
Cerebral Infarction
Brain Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia