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Non-invasive Brain Stimulation for People With Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Early Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Robot therapy and transcranial direct current stimulation
Sponsored by
University of Southampton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Health Sciences, University of Southampton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Robot Therapy and Real Transcranial Direct Current Stimulation

Robot Therapy and sham tDCS

Arm Description

This group will involve carrying out robot therapy and real transcranial Direct Current Stimulation (tDCS).

Participants will be randomised to group 2 whereby they will carry out the same robot therapy programme however, receiving sham stimulation.

Outcomes

Primary Outcome Measures

Report change in upper limb function from baseline to 8 weeks and 3 months after treatment
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
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.

Full Information

First Posted
July 21, 2011
Last Updated
June 22, 2016
Sponsor
University of Southampton
Collaborators
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT01405378
Brief Title
Non-invasive Brain Stimulation for People With Stroke
Official Title
Combining Transcranial Direct Current Stimulation (tDCS) With Robot Therapy for the Impaired Upper Limb in Stroke Rehabilitation.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southampton
Collaborators
University College, London

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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. Ethical Approval was sought from NHS NRES Committee South Central- Southampton B (Ref: 11/SC/0345) to conduct this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot Therapy and Real Transcranial Direct Current Stimulation
Arm Type
Experimental
Arm Description
This group will involve carrying out robot therapy and real transcranial Direct Current Stimulation (tDCS).
Arm Title
Robot Therapy and sham tDCS
Arm Type
Placebo Comparator
Arm Description
Participants will be randomised to group 2 whereby they will carry out the same robot therapy programme however, receiving sham stimulation.
Intervention Type
Device
Intervention Name(s)
Robot therapy and transcranial direct current stimulation
Intervention Description
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).
Primary Outcome Measure Information:
Title
Report change in upper limb function from baseline to 8 weeks and 3 months after treatment
Description
Measures sensorimotor function of the upper limb (Sanford et al. 1993; Fugl-Meyer et al. 1975)
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
Secondary Outcome Measure Information:
Title
Report change in cortical excitability from baseline to 8 weeks and 3 months after treatment
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a confirmed clinical diagnosis of a haemorrhagic or an ischaemic stroke confirmed clinically or by CT, PET or MRI Scan Experienced a single (first) stroke or multiple strokes 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) Have had a subcortical or cortical stroke Be over the age of 18 years Have any level of upper limb impairment Exclusion Criteria: A history of epilepsy (TMS studies) due to the fact that TMS could cause an epileptic fit Impaired gross cognitive function; score of less than 24 of the Mini-Mental State Examination (Folstein et al. 1975) Any metal implants in the head including cochlear implants Any another neurological condition apart from stroke Are currently participants in another intervention study using TMS/tDCS
Facility Information:
Facility Name
Faculty of Health Sciences, University of Southampton
City
Southampton
ZIP/Postal Code
SO17 1BJ
Country
United Kingdom

12. IPD Sharing Statement

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Non-invasive Brain Stimulation for People With Stroke

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