rTMS Effect on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia

NCT ID: NCT06356805

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2024-02-20

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active rTMS

Active rTMS of 1 Hz at an intensity of 120% RMT for 60 seconds(20 Trains), with a 45-second gap between trains giving a total of 1,200 pulses/day with the center of coil over rt DLPFC (5cm anterior to hand area). Five sessions/week for 4 consecutive weeks were applied

Group Type: ACTIVE_COMPARATOR

repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

Parallel study: Participants are assigned to one of two groups in parallel for 3 months follow up

Sham rTMS

Sham rTMS of 1 Hz at an intensity of 120% RMT for 60 seconds (20 Trains), with a 45-second gap between trains giving a total of 1,200 pulses/day with the coil held perpendicular to the rt DLPFC (5cm anterior to hand area). Five sessions/week for 4 consecutive weeks were applied.

Group Type: SHAM_COMPARATOR

repetitive transcranial magnetic stimulation

Intervention Type: DEVICE

Parallel study: Participants are assigned to one of two groups in parallel for 3 months follow up

Interventions

repetitive transcranial magnetic stimulation

Parallel study: Participants are assigned to one of two groups in parallel for 3 months follow up

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

The diagnosis of fibromyalgia was made according to American College of Rheumatology criteria with age at and older than 18 years

Exclusion Criteria

Inflammatory rheumatic disease, auto immune disease, or other painful disorders. Any uncontrolled clinical disease (such as thyroid, cardiovascular, pulmonary, hematological, or renal disease) that affects cognition. Pregnancy, lactation. patients have one of Contra-indications for rTMS (a history of seizures, brain trauma, brain surgery or intracranial hypertension, a pacemaker, or other metallic implants), Past history of other neurological disorders (neurodegenerative diseases, dementia), or primary psychiatric disorders (psychosis, or major depression (17-item Hamilton Depression Rating Scale > 23), or drug treatments that affect cognition. Inability to cooperate with the questionnaire survey or the patient refuses to participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: collaborator

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Eman M. Khedr

professor of neurology/Faculty of medicine, Assiut University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman Khedr, professor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Eman Khedr

Asyut, , Egypt

Countries

Egypt

Other Identifiers

rTMS in Fibromyalgia

Identifier Type: -

Identifier Source: org_study_id