Interventional Neuromodulation in Fibromyalgia
Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation on Sleep Disorders in Fibromyalgia Patients : A Double Blinded, Randomized Clinical Trial
Tanta University
60 participants
Nov 1, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- Age between 20 to 50 years.
- Regular appropriate trial of medical treatment for at least 3 months.
- Educated participants at least 12 years.
Exclusion Criteria7
- Inflammatory rheumatic disease, auto immune disease or other painful disorders.
- Any uncontrolled clinical disease (such as thyroid, cardiovascular, pulmonary, hematological or renal disease) that affect the cognition.
- pregnancy, lactation.
- Contra indications for transcranial magnetic stimulation-a history of seizures, brain trauma, brain surgery or intracranial hypertension, a pace maker or other metallic implants.
- Past history of major sleep disorders(narcolepsy, parasomnia or sleep apnea).
- Illicit drug or alcohol abuse.
- Inability to cooperate with the questionnaire survey.
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Interventions
This study was conducted on 20 eligible fibromyalgia patients with sleep disorders. They were randomized to have 20 sessions of active 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.
This study was conducted on 20 eligible fibromyalgia patients with sleep disorders. They were randomized to have 20 sessions of 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06373445