To assess whether 10 sessions of cTBS of the contralesional primary motor cortex combined with regular care upper limb training, started within three weeks after stroke onset, are effective and cost effective in promoting upper limb recovery after…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The upper extremity section of the Fugl-Meyer assessment (FM-UE) at 90 days
post-stroke.
Secondary outcome
The FM-UE at 12 months post-stroke.
The Action Research Arm Test (ARAT) at 90 days and 12 months post-stroke.
Activities of daily living (ADL), memory, handfunction and participation
sections of the Stroke Impact Scale (SIS) at 90 days and 12 months post-stroke.
Nine Hole Peg Test at 90 days and 12 months post-stroke.
modified Rankin Scale at 90 days and 12 months post-stroke.
EuroQol-5D at 90 days and 6 and 12 months post-stroke.
iMTA medical consumption and productivity cost questionnaire
Length of stay
Ipsilesional excitability after the 10th cTBS session (optional)
Contralesional excitability before the 1st, 6th and 10th cTBS session
TMS disruption at baseline
Background summary
Every year, about 40,000 people in the Netherlands have a stroke. After the
initial admission to the hospital, about 15% of stroke survivors is admitted to
a rehabilitation center. These patients are younger (average age of about 60
years) than those discharged to a chronic nursing facility and have more severe
motor impairments than those discharged home. About 75% of these patients has
upper limb dysfunction, which significantly hampers activities of daily living.
Upper limb function plays a critical role in the performance of all daily life
activities (like eating, taking a shower, using a computer, riding a bike,
etc.). Most everyday activities require the use of both hands. Improved arm and
hand function positively contributes to societal participation and quality of
life. Incomplete upper limb recovery has been found to be the strongest
predictor of lower health-related quality of life, across almost all
quality-of-life domains (except mobility), even after correcting for stroke
characteristics. Moreover, stroke survivors with a high score on a life
satisfaction scale reported better manual ability.
Data from our phase-2 trial (B-STARS) indicate that continuous theta burst
stimulation (cTBS) treatment, a form of repetitive transcranial magnetic
stimulation (rTMS) results in 17% additional recovery of upper limb function,
as measured with the ARAT score three months after stroke. This improvement
exceeds the minimal clinically important difference of 10%. This additional
recovery led to a significant improvement in the activity and participation
domain (of similar magnitude) and a reduction in the length of stay at the
rehabilitation center by 18 days on average.
Study objective
To assess whether 10 sessions of cTBS of the contralesional primary motor
cortex combined with regular care upper limb training, started within three
weeks after stroke onset, are effective and cost effective in promoting upper
limb recovery after stroke, compared to sham stimulation.
Study design
A multi-center double-blind randomized sham(placebo)-controlled clinical trial.
Intervention
10 daily sessions of cTBS delivered over the contralesional primary motor
cortex during a period of 2 weeks, delivered before regular care physical
therapy of the affected upper limb.
Study burden and risks
Data from our phase-2 trial (B-STARS) indicate that cTBS treatment results in
17% additional recovery of upper limb function, as measured with the
ARAT score three months after stroke. This improvement exceeds the minimal
clinically important difference of 10%. This additional recovery led to a
significant improvement in the activity and participation domain (of similar
magnitude) and a reduction in the length of stay at the rehabilitation center
by 18 days on average.
Risks associated with participation were limited. Side effects in the active
group were limited to headache (<4%) and muscle pain (<1%). The risk of
inducing an epileptic seizure is very small (0.02%) and consequences of an
epileptic seizure can be mitigated by adequate training of personnel.
Participating in the optional TMS measurement at De Hoogstraat Rehabilitation
has a negligible increase in the risk of TMS-related side effects.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
Age, 18 years or older;
First-ever unilateral ischemic stroke or intracerebral hemorrhage in a cerebral
hemisphere or the brainstem;
Unilateral upper limb paresis with a motricity index between 9 and 99;
Possibility to start cTBS treatment within 21 days after stroke onset;
Signed informed consent.
Exclusion criteria
Upper limb paresis prior to stroke onset;
Magnetically sensitive objects implanted in or guided through the head or neck
area (e.g. cochlear implants, implanted neurostimulator, pacemaker or
defibrillator leads, metal splinters, metal fragments or metal clips) with the
exception of dental work (e.g. fillings, braces or implants), history of
epilepsy, pregnancy or other contra-indications that may potentially be harmful
as determined by the treating rehabilitation physician;
Incapacity or severe impairments (i.e. extreme fatigue, major communication
deficits) that can impede study participation as determined by the treating
rehabilitation physician;
Life expectancy shorter than one year.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85511.041.24 |