Can Theta Burst stimulation accelerate re-learning of impaired wrist and hand movements early after stroke?

ISRCTN	ISRCTN99874413
DOI	https://doi.org/10.1186/ISRCTN99874413
Secondary identifying numbers	4528

Submission date: 18/06/2010
Registration date: 18/06/2010
Last edited: 06/12/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Ulrike Hammerbeck
Scientific

Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom

Email	u.hammerbeck@ion.ucl.ac.uk

Study information

Study design	Multicentre randomised interventional treatment trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study acronym	TBS3 study
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2008
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned sample size: 30; UK sample size: 26
Key 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
Key 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)
Date of first enrolment	01/01/2008
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Institute of Neurology

London
WC1N 3BG
United Kingdom

Sponsor information

University College London Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

250 Euston Road
London
NW1 2PG
England
United Kingdom

Website	http://www.uclh.nhs.uk/
"ROR"	https://ror.org/042fqyp44

Funders

Funder type

Research organisation

The Stroke Association (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2012		Yes	No