To determine the therapeutic effect of contralesional cTBS on recovery of function of the paretic arm, at 3 months after ischemic stroke
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Performance on an upper limb function test of the paretic arm.
Secondary outcome
Performance on additional upper limb function tests, tests on disability and
quality of life and neural network reorganisation. Optional are the MRI scans
and a single interview.
Background summary
Many surviving stroke patients are left with moderate to severe functional
deficits and long-term dependency on rehabilitation services. The most common
functional deficits after stroke are sensorimotor impairments, especially no or
limited ability to execute muscle movements with the affected arm or hand.1-2
Hemiparetic stroke recovery is often associated with an imbalanced interaction
between the damaged and undamaged hemispheres, with reduced excitability of the
ipsilesional primary motor cortex (M1) while excitability in the contralesional
M1 is increased.19-25 Theta Burst Stimulation (TBS), one of many forms of rTMS,
can elicit significant behavioral improvement in recovering stroke
patients.26-28 Despite these promising findings, a randomized controlled trial
(RCT) on the long term effects of TBS treatment in subacute, hemiparetic stroke
patients is lacking.35-37 We hypothesize that in stroke patients who receive
TBS the upper limb motor recovery is more pronounced (faster with higher motor
scores) in contrast to patients receiving sham TBS.
Study objective
To determine the therapeutic effect of contralesional cTBS on recovery of
function of the paretic arm, at 3 months after ischemic stroke
Study design
A double-blind randomized placebo-controlled intervention study. Patients will
be randomly assigned to one of two groups: one group of patients will receive
cTBS stimulation and the other group will receive sham stimulation. Both groups
will receive stimulation (followed by standard care upper limb training) for 10
days, during 2 weeks, and will be tested 7 times (in total). Optional are the
MRI scans and a single interview.
Intervention
Contralesional cTBS over the hand area of the primary motor cortex on a daily
basis for 2 weeks (except the weekends). Sham stimulation will be done with a
reverse coil orientation.
Study burden and risks
TBS is relatively well-tolerated in the adult and child population according to
several systematic reviews. Generally, it is a safe technique, especially when
safety guidelines are followed.58-61 The burden will consist of daily
stimulation sessions, lasting 40 seconds, (during two weeks) and multiple
outcome measurements (at baseline and at 6 follow-up time-points). This is
extensive, but the research can only be performed with these patient groups.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
1) Adult patient age * 18;
2) first-ever unilateral ischemic and hemorrhagic stroke (i.e., within the
cerebral hemispheres, brainstem);
3) paresis of one arm, with a SA score shoulder abduction *9 (Motricity Index);
4) within the first 3 weeks after stroke onset;
5) signed informed consent.
Exclusion criteria
1) Disabling medical history (severe or recent heart disease, severe head
trauma, coercively treated at a psychiatric ward);
2) history of epilepsy;
3) Normal to almost normal use of hand; maximum Motricity Index hand score
(score of 33)
4) severe deficits in communication, memory, or understanding that impede
proper study participation, as determined by the treating physician;
5) contraindications for TMS (e.g. metal (implants) in skull/scalp/head or
fragments from welding or metalwork, implanted device, pregnancy). N.B. metal
fillings (i.e. conductive) or non-ferromagnetic dental implants are an
exception to the rule.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58423.041.16 |
| OMON | NL-OMON19906 |