Transcranial Stimulation and Motor Training in Stroke Rehabilitation

Stroke Clinical Trial

— tDCS  

Official title:

Transcranial Direct Current Stimulation (tDCS) as a Potential Adjunct Intervention in Stroke Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01414582
• Other study ID #: 10/H0604/98
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: August 4, 2011
• Last updated: June 19, 2012
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: June 2012
• Source: University of Oxford
• Contact: Heidi Johansen-Berg, Prof.
• Phone: 01865 222799
• Email: heidi[@]fmrib.ox.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study aims to test whether repeated sessions of tDCS result in long-lasting improvements in motor function in patients with chronic stroke.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Cerebral Infarction
• Cerebrovascular Disorders
• Stroke

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Centre for Functional MRI of the Brain (FMRIB)	Oxford

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	National Institute for Health Research, United Kingdom, The Dunhill Medical Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Secondary	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.	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.	No
Secondary	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.	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.	No