Transcranial Stimulation and Motor Training in Stroke Rehabilitation | Recruiting
Transcranial Stimulation and Motor ... | Recruiting
Transcranial Stimulation and Motor Training in Stroke Rehabilitation
tDCS

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Medical Conditions
  • Stroke
  • Cerebral Infarction
  • Cerebrovascular Disorders
  • Brain Diseases
Primary Contact Details
Heidi Johansen-Berg, Prof.
01865 222799
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT01414582

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This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
This study aims to test whether repeated sessions of tDCS result in long-lasting improvements in motor function in patients with chronic stroke.
Research Details
  • 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.
Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Device : Anodal tDCS, Other : Motor Training

Study Arm Groups : Anodal tDCS and Motor Training, Anodal tDCS and Motor Training, Sham tDCS and Motor Training

Intervention Type
See Interventions above
Primary Outcome Measures
    Fugl Meyer Assessment of Motor Recovery following Stroke; 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.; Wolf Motor Function Test; 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.; Action Research Arm Test; 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.; 9 Hole Peg Test; 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 Measures
    Reaction Time Test; 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.; Stroke Impact Scale; 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.
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Both
Age Range
18 Years - 80 Years
Who Can Participate
Patients
Number of Participants
80
Participant Inclusion 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.
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Local Institution
Oxford
Oxfordshire
Trial Contact(s)
Primary Trial Contact
Heidi Johansen-Berg, Prof.
01865 222799
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
Transcranial Direct Current Stimulation (tDCS) as a Potential Adjunct Intervention in Stroke Rehabilitation
EudraCT Number
Not available for this trial
Funder(s)
  • National Institute for Health Research, United Kingdom
  • The Dunhill Medical Trust
Other Study ID Numbers
10/H0604/98
Sponsor(s)
University of Oxford
Key Dates

Recruitment Start Date

Jan 2011

Recruitment End Date

Dec 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

04 Aug 2011

Date updated in source

19 Jun 2012