Condition category
Circulatory System
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
06/12/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.uclh.nhs.uk/

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

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22412171

Publication citations

  1. 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.

Additional files

Editorial Notes