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ISRCTN
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ISRCTN99874413
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ClinicalTrials.gov identifier
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Public title
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Can Theta Burst stimulation accelerate re-learning of impaired wrist and hand movements early after stroke?
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Scientific title
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A multicentre randomised interventional treatment trial of theta burst stimulation to accelerate re-learning of impaired wrist and hand movements early after stroke
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Acronym
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TBS3 study
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Serial number at source
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4528
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Study hypothesis
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26 patients with a first-ever motor stroke initially affecting the hand will be recruited from 5 sites: the National Hospital for Neurology and Neurosurgery, the Homerton, the Whittington, St Georges and St Marys Hospitals.
We will invite patients who are still having mild to moderate problems with their hand function 1 - 3 months after the stroke. Potential participants will be approached and informed about the study by the member of the research team responsible for their care. All research procedures will take place at the Institute of Neurology.
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Lay summary
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Ethics approval
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The National Hospital of Neurology and Neurosurgery and Institute of Neurology Joint Research Ethics Committee approved on the 1st November 2007 (ref: 07/H0715/94)
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Study design
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Multicentre randomised interventional treatment trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Device used, Therapy type
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Participants - inclusion criteria
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1. First ever ischaemic stroke (previous transient ischaemic attack [TIA] is not a problem)
2. One to three months post stroke
3. Some movement in the wrist and fingers (wrist extension greater than or equal to 20° and thumb flexion greater than or equal to 10°)
4. English speaking
5. Aged over 18 years of age, either sex
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Participants - exclusion criteria
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1. Intracerebral or subarachnoid haemorrhage
2. Large strokes (greater than 50% of the middle cerebral artery [MCA] territory)
3. Increased muscular tone (greater than 2 in the Ashworth scale or not able to let go after grip without using the intact hand)
4. Cardiac pacemaker or intracardiac lines
5. Metallic objects in the head or in the eyes (e.g. clips from surgery, exposure to fast metallic flakes; metal in the mouth/teeth is not a problem)
6. Any history of epilepsy or fits including childhood
7. Inability to consent or comply with the study procedures (cognitive impairment, significant aphasia, visual field defect, or non-English speakers)
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Anticipated start date
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01/01/2008
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Anticipated end date
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31/12/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned sample size: 30; UK sample size: 26
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Interventions
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Motor training:
We will study how patients can learn to improve their performance in three different movements that are important for fine hand function: wrist extension (needed for grasping and releasing), precision grip and thumb opposition (both needed for grasping and manipulation). The training involves repetitions of the respective movement in 10 blocks of 15 trials, separated by 1 minute periods of rest. In this way, the total amount of training for each movement will be around 15 minutes.
Theta Burst Stimulation:
Theta Burst Stimulation (TBS)(Huang 2005) is a form of RTMS: very short bursts of stimuli (3 pulses at 50 Hz) are repeated five times every second using low intensity stimulation (80% of active motor threshold). In normal subjects, when TBS is applied in a specific excitatory pattern, termed iTBS, over the hand motor area excitability is enhanced for up to 1 hour. We have shown that iTBS can increase the excitability of the stroke side in chronic stroke patients in a similar way.
Control Group:
The control group performs the same exercise regime but receives sham transcranial magnetic stimulation (TMS).
Participation in each arm of the trial is one week.
Study entry: single randomisation only
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Primary outcome measure(s)
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Motor performance, collected during each practice
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Secondary outcome measure(s)
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Standardised tests of the arm and hand function that have been used repeatedly to assess recovery, performed on day 1 and 5:
1. Action Research Arm Test (ARAT)
2. Jebsen Taylor Hand Test
3. 9-Hole Peg Test
4. Electrophysiological measures of corticospinal excitability determined by TMS
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Sources of funding
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The Stroke Association (UK)
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Trial website
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Publications
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Contact name
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Ms
Ulrike
Hammerbeck
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Address
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Institute of Neurology
Queen Square
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City/town
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London
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Zip/Postcode
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WC1N 3BG
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Country
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United Kingdom
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Email
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u.hammerbeck@ion.ucl.ac.uk
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Sponsor
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University College London Hospitals NHS Foundation Trust (UK)
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Address
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250 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2PG
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Country
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United Kingdom
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Sponsor website:
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http://www.uclh.nhs.uk/
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Date applied
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18/06/2010
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Last edited
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23/11/2010
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Date ISRCTN assigned
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18/06/2010
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