rTMS Effect on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia

Assiut University

Status: Completed

Conditions: Treatment Resistant Disorders

Treatments: Device: repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06356805

rTMS in Fibromyalgia

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

42 participants in 2 patient groups

Active rTMS

Active Comparator group

Description:

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

Treatment:

Device: repetitive transcranial magnetic stimulation

Sham rTMS

Sham Comparator group

Description:

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.

Treatment:

Device: repetitive transcranial magnetic stimulation