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Investigation of changes in the structure and function of the brain in musicians using magentic resonance tomography

Phase 1
Conditions
Focal dystonia in musicians
Therapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]
Registration Number
EUCTR2020-000160-28-AT
Lead Sponsor
Medical University of Vienna
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
80
Inclusion Criteria

-Diagnosis of primary focal upper extremity dystonia
-General health based on medical history, physical examination and structured clinical interview for DSM-IV (SCID)
-Age 18 to 60 years
-Willingness and competence to sign the informed consent form.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-History of any neurological or psychiatric disease (other than focal dystonia)
-Any unstable medical condition
-Injection of botulinum toxin A within the past 3 months
-Current of former substance abuse
-Psychopharmacological treatment within 3 months prior to inclusion
-Pregnancy
-Any implant or stainless steel graft or any other contraindications for MRI.
-Body mass index <17 or >30 (Erritzoe, Frokjaer et al. 2010)
-Failure to comply with the study protocol or to follow the instruction of the investigating team.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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