Non-invasive Brain Stimulation for People With Stroke

This study has been completed.
Sponsor:
Collaborator:
University College, London
Information provided by (Responsible Party):
Jane Burridge, PhD, University of Southampton
ClinicalTrials.gov Identifier:
NCT01405378
First received: July 21, 2011
Last updated: December 3, 2015
Last verified: May 2011
  Purpose
Every five minutes someone in the UK has a stroke. It is the main cause of long-term disability among adults in the UK despite a fall in age-specific stroke incidence, with a growing number of survivors remaining dependent for activities of daily living. While most people with stroke regain walking ability, upper limb problems with no voluntary arm and hand activity, affecting a third of people after stroke, has a poor prognosis. Transcranial direct current stimulation (tDCS) is a non-invasive procedure used to polarise brain regions through the application of weak direct currents and has the potential to develop into a useful aid to treatment strategies in neurorehabilitation. Recent literature into the application of tDCS in people with arm and hand impairments after stroke has shown promising results on upper limb function measures like the Jebsen-Taylor hand function test. Furthermore, a recent pilot study evaluated a six-week training programme combining tDCS with robot-assisted hand training and reported significant improvements in upper limb function. However, the robot in the latter study focused on single-plane distal movements only and long-term effects of the tDCS were not assessed. Recent robotic developments included robots with three rotational degrees-of-freedom for the upper limb, but the effectiveness of this type of robot combined with tDCS in early stroke settings is unknown.

Condition Intervention Phase
Sub-Acute Stroke
Device: Robot therapy and transcranial direct current stimulation
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combining Transcranial Direct Current Stimulation (tDCS) With Robot Therapy for the Impaired Upper Limb in Stroke Rehabilitation.

Further study details as provided by University of Southampton:

Primary Outcome Measures:
  • Report change in upper limb function from baseline to 8 weeks and 3 months after treatment [ Time Frame: Will be used, exactly before commencing training programme (day 1), at the end of the 8 week training programme and at 3 months follow-up ] [ Designated as safety issue: No ]
    Measures sensorimotor function of the upper limb (Sanford et al. 1993; Fugl-Meyer et al. 1975)


Secondary Outcome Measures:
  • Report change in cortical excitability from baseline to 8 weeks and 3 months after treatment [ Time Frame: Will be used, exactly before commencing training programme (day 1), at the end of the 8 week training programme and at 3 months follow-up ] [ Designated as safety issue: No ]
    Corticospinal excitability will be measured by the administration of focal TMS using a figure-of-eight coil to the M1 area of the affected hemisphere. The 'hot spot' will be established by using neuronavigation equipment called Brain Sight (Rogue Research Inc.). The amplitude of the MEPs and recruitment curve of the anterior deltoid (proximal muscle) and extensor digitorum communis (distal muscle) will be subsequently recorded using electromyography.


Enrollment: 23
Study Start Date: October 2011
Study Completion Date: February 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robot Therapy and Real Transcranial Direct Current Stimulation
This group will involve carrying out robot therapy and real transcranial Direct Current Stimulation (tDCS).
Device: Robot therapy and transcranial direct current stimulation

Administration of Robot Therapy:

Therapy will be administered by making use of the Armeo Robot. Sessions will involve high-intensity, repetitive, task-oriented movements directed by video screens. Administration of tDCS:

Anodal tDCS will be administered using a CE marked transcranial Direct Current Stimulator (Newronika Italy). Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35 cm2).

Placebo Comparator: Robot Therapy and sham tDCS
Participants will be randomised to group 2 whereby they will carry out the same robot therapy programme however, receiving sham stimulation.
Device: Robot therapy and transcranial direct current stimulation

Administration of Robot Therapy:

Therapy will be administered by making use of the Armeo Robot. Sessions will involve high-intensity, repetitive, task-oriented movements directed by video screens. Administration of tDCS:

Anodal tDCS will be administered using a CE marked transcranial Direct Current Stimulator (Newronika Italy). Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35 cm2).


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have a confirmed clinical diagnosis of a haemorrhagic or an ischaemic stroke confirmed clinically or by CT, PET or MRI Scan
  2. Experienced a single (first) stroke or multiple strokes
  3. In the acute, sub-acute or chronic phase of their recovery (the first three to seven days are referred to as the acute phase. The first two weeks to six months are defined as the sub-acute phase, and the chronic phase begins after three or six months (Teismann et al. 2011, Duncan et al. 2003a)
  4. Have had a subcortical or cortical stroke
  5. Be over the age of 18 years
  6. Have any level of upper limb impairment

Exclusion Criteria:

  1. A history of epilepsy (TMS studies) due to the fact that TMS could cause an epileptic fit
  2. Impaired gross cognitive function; score of less than 24 of the Mini-Mental State Examination (Folstein et al. 1975)
  3. Any metal implants in the head including cochlear implants
  4. Any another neurological condition apart from stroke
  5. Are currently participants in another intervention study using TMS/tDCS
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405378

Locations
United Kingdom
Faculty of Health Sciences, University of Southampton
Southampton, United Kingdom, SO17 1BJ
Sponsors and Collaborators
University of Southampton
University College, London
  More Information

No publications provided

Responsible Party: Jane Burridge, PhD, Professor, University of Southampton
ClinicalTrials.gov Identifier: NCT01405378     History of Changes
Other Study ID Numbers: Wessex Innovative Grant P09 
Study First Received: July 21, 2011
Last Updated: December 3, 2015
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on February 09, 2016