Theta Burst Stimulation for motor impairment after stroke

ISRCTN ISRCTN03884521
DOI https://doi.org/10.1186/ISRCTN03884521
Protocol serial number 3279; G0401353
Sponsor University College London Hospitals NHS Foundation Trust (UK)
Funder Medical Research Council (MRC) (UK) (ref: G0401353)
Submission date
29/04/2010
Registration date
29/04/2010
Last edited
26/07/2013
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
Queen Square
London
WC1N 3BG
United Kingdom

Study information

Primary study designInterventional
Study designRandomised interventional treatment trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleEnhancing the effect of physical therapy for motor impairment after stroke with Theta Burst Stimulation
Study acronymTBS Study
Study objectivesIn this study we plan to investigate whether brain stimulation can be used as an add-on treatment to consolidate the benefit from patterned upper limb physiotherapy and induce further hand motor improvement in chronic stroke patients.

To stimulate the brain we plan to use Theta Burst Stimulation (TBS), a novel paradigm of repetitive transcranial magnetic stimulation (TMS), aiming to increase cortical excitability of the affected (ipsilesional) hemisphere.

According to evidence so far, we believe that increased ipsilesional excitability can be achieved by:
1. Direct facilitation of the affected hemisphere (ipsilesional facilitation)
2. Inhibition of the unaffected hemisphere (contralesional inhibition)

Primary aim:
To investigate whether daily treatment with TBS followed by patterned physical therapy for a period of two weeks can lead to significant and sustained improvement of hand motor behavior in chronic stroke patients.

Secondary aims:
1. To study the physiological correlates of the potential behavioral gains
2. To identify physiological predictors of likelihood of response to the proposed intervention, so that appropriate patients may be targeted in future trials

Physiological correlates will be studied using TMS and functional magentic resonance imaging (fMRI) as detailed below.
Ethics approval(s)NHNN and ION Joint Research Ethics Committee approved on the 25/02/2005 (ref: 04/Q0512/108)
Health condition(s) or problem(s) studiedTopic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Therapy type
InterventionPhysical therapy (physiotherapy):
The protocol for physical therapy has been developed in collaboration with the therapy services department at the National Hospital for Neurology and Neurosurgery. It expands upon previous protocols by ensuring the equivalence of task intensity, repetition rate and verbal feedback across subjects. Treatment will be task oriented and individualised based on the findings of a questionnaire about current functional difficulties and an objective examination.

Theta Burst Stimulation:
TMS is a well tolerated method of stimulating the human cortex through the intact scalp. We will employ a new pattern of repetitive TMS called Theta Burst Stimulation (TBS). Each burst consists of 3 low intensity (80% aMT, see further on) stimuli, repeating at high frequency (50Hz). Bursts are repeating at 5Hz, i.e. the "theta" rhythm of the EEG. A total of 15 pulses are delivered per second. TBS effect on corticospinal excitability can be either inhibitory of facilitatory, depending on the pattern.

Follow up length: 3 months
Study entry: single randomisation only
Intervention typeOther
Primary outcome measure(s)

Action Research Arm Test, measured at initial assessment, 2 day post-intervention follow-up, 1 month follow-up and 3 month follow-up.

Key secondary outcome measure(s)

1. Electrophysiological measures of corticospinal excitability, intracortical interactions and interhemispheric balance, measured at initial assessment, 2 day post-intervention follow-up, 1 month follow-up and 3 month follow-up
2. Functional Magnetic Resonance Imaging: Measurement of motor and sensory related brain activation only performed at initial and two day post intervention follow-up

Completion date31/12/2010

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration45
Key inclusion criteria1. History of a single ischaemic stroke, initially affecting the hand
2. Minimum interval since stroke onset one year (no upper limit)
3. Residual impairments of hand function (strength and/or dexterity)
4. Some degree of hand movement defined as present wrist extension (>=20%) and ability to grasp
5. Capable of giving informed consent
6. Aged 18 - 80 years, either sex
Key exclusion criteria1. Intracerebral hemorrhage
2. Large ischaemic lesions involving almost the whole MCA territory
3. Significant tone problems in the hand (greater than 2 in the Ashworth Scale)
4. Severe cognitive impairment defined as mini-mental state examination (MMSE) less than 20
5. Residual aphasia or visual field defect (greater than or equal to 2 in the relative item of the National Institutes of Health Stroke Scale [NIHSS])
6. Past or current history of other neurological or psychiatric disease including epilepsy, previous or recurrent stroke and peripheral neuropathy
7. Major systemic illness
8. Use of anticonvulsant, psychotropic or sedative or medication
9. Excessive use of alcohol or other substances
10. Accepted contraindications for TMS (presence of metal in the head (excluding the mouth), intracardiac lines, cardiac pacemakers)
Date of first enrolment01/11/2005
Date of final enrolment31/12/2010

Locations

Countries of recruitment

  • United Kingdom
  • England
  • Italy

Study participating centre

Institute of Neurology
London
WC1N 3BG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
BMC - Part of Springer Nature Springer Nature