Transcranial Stimulation and Motor Training in Stroke Rehabilitation

NCT01414582 | Unknown Phase 2

• 1 other identifier: 10/H0604/98
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebral Infarction; Cerebrovascular Disorders; Brain Diseases

Keywords

tDCS; Stroke; Functional MRI; Motor Learning

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  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

  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.

  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

  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.

  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 Outcomes (2)

• 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.

Study Arms (2)

Anodal tDCS and Motor Training

EXPERIMENTAL

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; Other: Motor Training

Sham tDCS and Motor Training

SHAM COMPARATOR

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

Interventions

Anodal tDCS DEVICE

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).

Anodal tDCS and Motor Training

Motor Training OTHER

All participants will receive a standardised motor training intervention for the upper paretic limb

Anodal tDCS and Motor Training; Sham tDCS and Motor Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oxford: lead
• National Institute for Health Research, United Kingdom: collaborator
• The Dunhill Medical Trust: collaborator

Study Sites (1)

Centre for Functional MRI of the Brain (FMRIB)

Oxford, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke; Cerebral Infarction; Cerebrovascular Disorders; Brain Diseases

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Brain Ischemia; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Heidi Johansen-Berg, Prof.

CONTACT

01865 222799; heidi@fmrib.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2011
• First Posted: August 11, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 20, 2012

Record last verified: 2012-06

Locations

GB (1)