Electrophysiological and Neuroimaging Correlates of the Effect of Zolpidem in Patients With Focal Dystonia

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.

Conditions

• Focal Dystonia

Interventions

DRUG

Zolpidem

Patients will undergo transcranial magnetic stimulation, 18F-FDG-PET brain imaging, and clinical testing after a single 5 mg dose of Zolpidem.

DRUG

Placebo

Patients will undergo transcranial magnetic stimulation, 18F-FDG-PET brain imaging, and clinical testing after a single dose of placebo.

Sponsors & Collaborators

• Slovenian Research Agency

  collaborator OTHER

• Clinical Centre of Serbia

  collaborator OTHER

• University Medical Centre Ljubljana

  lead OTHER

Principal Investigators

• Maja Kojović, PhD, MD · University Medical Centre Ljubljana

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-30

Primary Completion

2021-04-30

Completion

2021-04-30

Countries

• Serbia
• Slovenia

Study Locations