Theta Burst Stimulation for motor impairment after stroke

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN03884521
• Date of registration: 29/04/2010
• Prospective Registration: No
• Primary sponsor: University College London Hospitals NHS Foundation Trust (UK)
• Public title: Theta Burst Stimulation for motor impairment after stroke
• Scientific title: Enhancing the effect of physical therapy for motor impairment after stroke with Theta Burst Stimulation
• Date of first enrolment: 01/11/2005
• Target sample size: 45
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN03884521
• Study type: Interventional
• Study design: Randomised interventional treatment trial (Treatment)

Countries of recruitment

Italy, United Kingdom

Contacts

• Name: Ulrike Hammerbeck

Key inclusion & exclusion criteria

Inclusion criteria: 1. 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
Exclusion criteria: 1. 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)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Therapy type
Circulatory System
Stroke

Intervention(s)

Physical 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

Primary Outcome(s)

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

Secondary Outcome(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

Secondary ID(s)

3279; G0401353

Source(s) of Monetary Support

Medical Research Council (MRC) (UK) (ref: G0401353)