Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation on Sleep Disorders in Fibromyalgia Patients : A Double Blinded, Randomized Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study was conducted on 40 eligible fibromyalgia patients with sleep disorders. They were randomized to have 20 sessions of active or sham rTMS (1 Hz, 120% of resting motor threshold with total 1200 pules /session) over the right dorsolateral prefrontal area (DLPFC) for 5 sessions/week for 4 weeks. All participants were subjected to baseline evaluation with Fibromyalgia Impact Questionnaire, polysomnography, sleep quality and sleep characteristics assessment using the Pittsburgh Sleep Quality Index and The Medical Outcomes Study Sleep Scale respectively.FM patients were reevaluated at 1, 3 months after the end of rTMS sessions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 50
Healthy Volunteers: f
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• Age between 20 to 50 years.

• Regular appropriate trial of medical treatment for at least 3 months.

• Educated participants at least 12 years.

Locations
Other Locations
Egypt
Faculty of medicine
RECRUITING
Tanta
Contact Information
Primary
Marwa Y Badr, MD neurology
drmoroneuro@yahoo.com
01003639125
Backup
Marwa Y Badr
drmoroneuro@yahoo.com
01003639125
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2024-04-15
Participants
Target number of participants: 60
Treatments
Experimental: Active group
The transcranial magnetic stimulation sessions were carried out using the MAGSTIM TMS equipment (Company Limited, Whitland, wales, UK). The investigators used the figure of eight or butterfly coil. The experimental group received real rTMS as follow: The intensity of the stimulus employed in treatment has used the motor threshold (MT) as the basic measure. The MT is used as a measurement index because the motor cortex is the only brain region which gives an easily detected signal \[muscle twitch\] when depolarized.The main stimulation parameters were 24 trains at120% of motor threshold for 60 seconds at 1 Hz and a 45-second interval between trains. The investigators subsequently provided a total of 1,200 pulses at each of the 20 sessions. The stimulation area was the right dorsolateral prefrontal area that was defined as the region 5 cm rostral in the same sagittal plane as the optimal site for MT production in the first dorsal interosseous
Sham_comparator: control group
The control group received sham rTMS as in the experimental group; however, sham current was with the coil placed perpendicular to the with the coil placed perpendicular to the scalp. The investigator responsible for delivering rTMS had no contact with the patients, ensuring a double-blind procedure.
Related Therapeutic Areas
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov