Primary objective: to assess cortical activity post stroke in a repetitive way to determine cortical involvement in dedicated motor tasks and to relate cortical activity to clinical outcome prospectively after stroke. Secondary objective: to assess…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
primary: cortico- muscular coherence, i.e. the concordance between brain and
muscle activity at different brain areas, expressed as a fraction
Secondary outcome
Secondary: clinical outcome as measured by the Action Research Arm Test (ARAT),
Motricity Index (MI) of arm and leg, Fugl-Meyer for the arm (FM-arm), Erasmus
modification of the Nottingham Sensory Assessment (EmNSA), Letter Cancellation
Task (LCT), Nine Hole Peg test (NHPT), a structured participant interview of
real arm use using the Motor Activity Log (MAL), Stroke Impact Scale (SIS
version 3.0) and Nottingham Extended ADL (NEADL).
Background summary
Current post stroke upper limb rehabilitation is unable to work beyond fixed
functional recovery patterns. Yet, functional MRI scanning reveals that the
post-stroke brain is plastic, i.e. alternative brain areas are recruited. To
make uses of the potential that brain plasticity has to offer, changes of brain
activity need to be measured repetitively during motor tasks in the stroke
recovery phase. State-of-the-art signal recording equipment and processing
techniques bring this goal within reach.
Study objective
Primary objective: to assess cortical activity post stroke in a repetitive way
to determine cortical involvement in dedicated motor tasks and to relate
cortical activity to clinical outcome prospectively after stroke. Secondary
objective: to assess reliability (test-retest) and validity (differences
between patients and healthy subjects) a of a concise measurement protocol
extracted out of existing protocols, that can easily be used in a clinical
setting.
Study design
Prospective study: repeated measures (assessments at fixed time intervals in
the post stroke recovery phase) and a within subjects factor, i.e. stroke
patients with a good respectively poor prognosis for arm function recovery;
cross sectional study with repeated measures for the second objective
Study burden and risks
Meaurements bear minimal risks. Patients and control subjects are asked to do
concentrated work for some time during which forces have to be exerted on a
haptic wrist manipulator. Patients within the prospective study are asked to
undergo a measurement session for in total five times. Wishes and possibilities
of patients, family and therapists are taken into account as much as possible
when sceduling the appointments. Patiens and control subjects within the
cross-sectional study are asked to undergo the measurements one more time after
the initial visit.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
regarding the primary objective: 1) an upper limb deficit, i.e. a NIHSS score of 1-4 in the second week post stroke; 2) a first-ever ischemic lesion in the territory of the MCA, verified by CT and/or MRI scan; 3) age between 40 and 75 years; 3) written or oral informed consent; 4) be able to sit for 30 seconds without support. Regarding the secondary objective: patients > 1 year post stroke with a motor deficit of the upper extremity NHSS *1; healthy volunteers within expected age range of stroke survivors, i.e. 40-75 years.
Exclusion criteria
1) a pacemaker or other metallic implants; 2) upper extremity orthopaedic limitations; 3) not being able to communicate i.e. < 4 points on the
Utrecht Communication Observation; 4) a Mini Mental State Examination, MMSE score of 22 points or less and 5) successful recombinant tissue plasminogen activator (rTPA, or alteplase) treatment.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39323.058.12 |