Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Ms Ulrike Hammerbeck


Contact details

Institute of Neurology
Queen Square
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


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


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


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Device used, Therapy type


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Institute of Neurology
United Kingdom

Sponsor information


University College London Hospitals NHS Foundation Trust (UK)

Sponsor details

250 Euston Road
United Kingdom

Sponsor type




Funder type

Research organisation

Funder name

The Stroke Association (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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:

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