NCT06356805

rTMS Effect on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia

Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia: A Double Blinded, Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

the aim of this work was to evaluate the effect of low frequency rTMS over the right dorsolateral prefrontal area (DLPFC) on Fibromyalgia patients. Fibromyalgia Impact Questionnaire (FIQ), Hamilton depression and Anxiety scale and different cognitive rating scales were evaluated pre-1 month post sessions and pre -post 3 months later. all eligible patients with fibromyalgia (FM) were randomized to have 20 sessions of active or sham rTMS over right DLPFC. The improvement changes in groups were compared in each rating scale.

Detailed description

The present study was aimed to evaluate the effect of low frequency rTMS over the right dorsolateral prefrontal area (DLPFC) on Fibromyalgia patients. recruitment of the patients were consecutively. Impact Questionnaire (FIQ), psychiatric and cognitive scales were evaluated before rTMS. 42 eligible patients with fibromyalgia (FM) were randomly assigned to one of two groups with equal ratio. each patient received 20 sessions of active or sham rTMS (1 Hz, 120% of resting motor threshold with total 1200 pules /session) over right DLPFC. follow up of each patient was done blindly at , one and 3 months later with the same rating scales (FIQ, Hamilton depression and anxiety Rating Scales (HDRS and HARS), Montreal Cognitive Assessment (MoCA), Rey Auditory Verbal Learning Test (RAVLT), Tower of London test (TOL), the Trail Making and Digit Span Tests). comparison between the changes in different rating scales were done at 1- and 3-months follow-up.

Conditions

• Treatment Resistant Disorders

Interventions

Type	Name	Description
DEVICE	repetitive transcranial magnetic stimulation	Parallel study: Participants are assigned to one of two groups in parallel for 3 months follow up

Timeline

• Start date: 2023-01-10
• Primary completion: 2024-01-30
• Completion: 2024-02-20
• First posted: 2024-04-10
• Last updated: 2024-04-10

Locations

1 site across 1 country: Egypt