Status:
UNKNOWN
dTMS as a Treatment for Patients With Fibromyalgia
Lead Sponsor:
Shalvata Mental Health Center
Conditions:
Studying Efficacy of dTMS in FM
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Purpose: The purpose of the study is to explore the efficacy of H1 deep TMS for the treatment of FMS. Design: Prospective randomized sham controlled trial Study Population \& sample size:forty (40) F...
Eligibility Criteria
Inclusion
- Age: 18-80 years.
- Patients who continue to take their administered medications or patients who stopped ineffective administered medications
- Concomitant medication for pain and sleep disorders will be allowed provided the dose administered had been stable for at least 2 weeks before enrollment and remains stable throughout the study.
- Gave informed consent for participation in the study.
Exclusion
- Subjects will be excluded if evidence is found of inflammatory rheumatic disease, autoimmune disease, or other painful disorders that might confound assessment of FMS pain.
- Subjects diagnosed with a current primary (Axis I) psychiatric condition according to Diagnostic and Statistical Manual of Mental Disorders-IV criteria, including anxiety disorders, not including major depression or major personality disorder. Subject with a history of substance abuse and pregnant women will be excluded as well.
- History of any metal in the head (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
- History of head injury.
- History of seizure or heat convulsion.
- History of epilepsy or seizure in first degree relatives.
- History of frequent or severe headaches.
- Use of hearing aids for hearing loss.
- Known history of cochlear implants.
- History of drug abuse or alcoholism during the last year.
- Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.
- Significant difficulties in language or communication.
- Subjects declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
- Participation in current clinical study or clinical study within 30 days prior to this study.
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03460340
Start Date
April 1 2018
End Date
April 1 2020
Last Update
March 9 2018
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