Contact information
Type
Scientific
Primary contact
Ms Ulrike Hammerbeck
ORCID ID
Contact details
Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom
u.hammerbeck@ion.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4528
Study information
Scientific title
A multicentre randomised interventional treatment trial of theta burst stimulation to accelerate re-learning of impaired wrist and hand movements early after stroke
Acronym
TBS3 study
Study hypothesis
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.
Ethics approval
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)
Study design
Multicentre randomised interventional treatment trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Device used, Therapy type
Intervention
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
Intervention type
Other
Phase
Phase II
Drug names
Primary outcome measure
Motor performance, collected during each practice
Secondary outcome measures
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
Overall trial start date
01/01/2008
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 30; UK sample size: 26
Participant exclusion criteria
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)
Recruitment start date
01/01/2008
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Neurology
London
WC1N 3BG
United Kingdom
Sponsor information
Organisation
University College London Hospitals NHS Foundation Trust (UK)
Sponsor details
250 Euston Road
London
NW1 2PG
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
The Stroke Association (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22412171
Publication citations
-
Results
Talelli P, Wallace A, Dileone M, Hoad D, Cheeran B, Oliver R, VandenBos M, Hammerbeck U, Barratt K, Gillini C, Musumeci G, Boudrias MH, Cloud GC, Ball J, Marsden JF, Ward NS, Di Lazzaro V, Greenwood RG, Rothwell JC, Theta burst stimulation in the rehabilitation of the upper limb: a semirandomized, placebo-controlled trial in chronic stroke patients., Neurorehabil Neural Repair, 2012, 26, 8, 976-987, doi: 10.1177/1545968312437940.