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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04692285
Other study ID # 0120-232/2016
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 30, 2017
Est. completion date April 30, 2021

Study information

Verified date November 2023
Source University Medical Centre Ljubljana
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Serbia University Clinical Centre of Serbia Belgrade
Slovenia Departmet of Neurology, University Medical Centre Ljubljana Ljubljana

Sponsors (3)

Lead Sponsor Collaborator
University Medical Centre Ljubljana Clinical Centre of Serbia, Slovenian Research Agency

Countries where clinical trial is conducted

Serbia,  Slovenia, 

References & Publications (4)

Kapogiannis D, Wassermann EM. Transcranial magnetic stimulation in Clinical Pharmacology. Cent Nerv Syst Agents Med Chem. 2008 Dec;8(4):234-240. doi: 10.2174/187152408786848076. — View Citation

Lehericy S, Tijssen MA, Vidailhet M, Kaji R, Meunier S. The anatomical basis of dystonia: current view using neuroimaging. Mov Disord. 2013 Jun 15;28(7):944-57. doi: 10.1002/mds.25527. — View Citation

Quartarone A, Hallett M. Emerging concepts in the physiological basis of dystonia. Mov Disord. 2013 Jun 15;28(7):958-67. doi: 10.1002/mds.25532. — View Citation

Thenganatt MA, Jankovic J. Treatment of dystonia. Neurotherapeutics. 2014 Jan;11(1):139-52. doi: 10.1007/s13311-013-0231-4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change in The Writer's Cramp Rating Scale (WCRS) between zolpidem 5 mg and placebo The writer's cramp dystonia can be objectively assessed using WCRS. The minimum score on WCRS is 0 and the maximum score is 30. The WCRS consists of two subscores, the writing movement score with the minimum score 0 and the maximum score 28 and the writing speed score with the minimum score 0 and the maximum score 2. The higher the score, the more is a patient affected with the writer's cramp dystonia. 30 minutes after the intervention
Other Change in the Visual Analog Score between zolpidem 5 mg and placebo To subjectively assess dystonia, the Visual Analog Scale will be used. The minimum score on the scale will be 0 and the maximum score will be 10. A higher score will mean a greater impairment due to the presence of dystonia. 30 minutes after the intervention
Primary Change in the transcranial magnetic stimulation measures between zolpidem 5 mg and placebo Transcranial magnetic stimulation measures (resting and active cortical motor threshold, resting and active input-output curve, short intracortical inhibition, long intracortical inhibition, intracortical facilitation) after zolpidem 5 mg and placebo will be compared. 30 minutes after the intervention
Primary Change in brain metabolism detected on FDG-PET CT brain imaging between zolpidem 5 mg and placebo FDG-PET CT brain imaging 30 minutes after the intervention
Secondary Change in The Burke-Fahn-Marsden Dystonia Rating Scale (BFMS) between zolpidem 5 mg and placebo Dystonia can be objectively assessed using the BFMS. The BFMS is subdivided into a movement scale and a disability scale. Only the movement scale will be used. The minimum total score is 0, the maximal total score is 120. Patients who are more affected with dystonia get higher scores. 30 minutes after the intervention
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