Electrophysiological and Neuroimaging Correlates of the Effect of Zolpidem in Patients With Focal Dystonia
Status:
Completed
Trial end date:
2021-04-30
Target enrollment:
Participant gender:
Summary
To study electrophysiological and imaging correlations of the clinical effectiveness of
zolpidem in task-specific dystonia and to elucidate mechanisms underlying its therapeutic
effects, patients with focal dystonia will be clinically evaluated and will undergo
transcranial magnetic stimulation and FDG-PET CT brain imaging after a single 5 mg dose of
zolpidem and placebo, in two separate sessions. Resting motor threshold (RMT), active motor
threshold (AMT), resting and active input/output (IO) curve, short-interval intracortical
inhibition (SICI) curve, long interval intracortical inhibition (LICI), intracortical
facilitation (ICF), and cortical silent period (CSP) will be measured. Objective clinical
improvement will be rated using Burke-Fahn-Marsden Dystonia Rating Scale-movement (BFM-M) and
writer's cramp rating scale (WCRS). Subjective improvement will be measured using the visual
analog scale (VAS). Only a subset of patients (10 patients) will undergo positron emission
tomography with 18F-2-fluoro-2-deoxy-D-glucose (18F-FDG PET) brain imaging after a single 5
mg dose of zolpidem and placebo.
Phase:
Phase 1
Details
Lead Sponsor:
University Medical Centre Ljubljana
Collaborators:
Clinical Centre of Serbia Slovenian Research Agency