Non-invasive Brain Stimulation for People With Stroke

NCT01405378 | Completed Early Phase 1 DMC

• 1 other identifier: Wessex Innovative Grant P09
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

  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 Outcomes (1)

• Report change in cortical excitability from baseline to 8 weeks and 3 months after treatment

  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

Study Arms (2)

Robot Therapy and Real Transcranial Direct Current Stimulation

EXPERIMENTAL

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

Device: Robot therapy and transcranial direct current stimulation

Robot Therapy and sham tDCS

PLACEBO COMPARATOR

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

Interventions

Robot therapy and transcranial direct current stimulation 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 Real Transcranial Direct Current Stimulation; Robot Therapy and sham tDCS

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southampton: lead
• University College, London: collaborator

Study Sites (1)

Faculty of Health Sciences, University of Southampton

Southampton, SO17 1BJ, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 29, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: February 1, 2014
• Last Updated: June 23, 2016

Record last verified: 2016-06

Locations

GB (1)