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Interventional Neuromodulation in Fibromyalgia

NCT06373445 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-04-18

No results posted yet for this study

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.

Conditions

  • Neuromodulation and Sleep Disorders

Interventions

DEVICE

repetitive transcranial magnetic stimulation active stimulation

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.

DEVICE

repetitive transcranial magnetic stimulation sham stimulation

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.

Sponsors & Collaborators

  • Tanta University

    lead OTHER

Principal Investigators

  • Eman Khedr, MD neurology · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-09-01
Completion
2024-04-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06373445 on ClinicalTrials.gov