Use of functional MRI to guide decisions in a clinical stroke trial.
OBJECTIVE
An investigational trial examined safety and efficacy of targeted subthreshold cortical stimulation in patients with chronic stroke. The anatomical location for the target, hand motor area, varies across subjects, and so was localized with functional MRI (fMRI). This report describes the experience of incorporating standardized fMRI into a multisite stroke trial.


METHODS
At 3 enrollment centers, patients moved (0.25 Hz) the affected hand during fMRI. Hand motor function was localized at a fourth center guiding intervention for those randomized to stimulation.


RESULTS
The fMRI results were available within 24 hours. Across 12 patients, activation site variability was substantial (12, 23, and 11 mm in x, y, and z directions), exceeding stimulating electrode dimensions.


CONCLUSIONS
Use of fMRI to guide decision-making in a clinical stroke trial is feasible.
Cramer
Steven C
SC
University of California, Irvine, Calif , USA. scramer@uci.edu
Benson
Randall R
RR
Himes
David M
DM
Burra
Vijaya C
VC
Janowsky
Jeri S
JS
Weinand
Martin E
ME
Brown
Jeffrey A
JA
Lutsep
Helmi L
HL
D000328:Adult; D000368:Aged; D002908:Chronic Disease; D046690:Deep Brain Stimulation; D005260:Female; D006801:Humans; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D009044:Motor Cortex / Q000473:pathology / Q000503:physiopathology; D020521:Stroke / Q000175:diagnosis*