Non-invasive Brain Stimulation for People With Stroke

NCT ID: NCT01405378

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2014-02-28

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Robot Therapy and Real Transcranial Direct Current Stimulation

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

Group Type: EXPERIMENTAL

Robot therapy and transcranial direct current stimulation

Intervention Type: DEVICE

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).

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.

Group Type: PLACEBO_COMPARATOR

Robot therapy and transcranial direct current stimulation

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College, London

OTHER

Sponsor Role: collaborator

University of Southampton

OTHER

Sponsor Role: lead

Responsible Party

Jane Burridge, PhD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Health Sciences, University of Southampton

Southampton, , United Kingdom

Countries

United Kingdom

Other Identifiers

Wessex Innovative Grant P09

Identifier Type: -

Identifier Source: org_study_id