Clinical trial NCT06356805: rTMS Effect on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia
Official title: Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia: A Double Blinded, Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Treatment Resistant Disorders
Keywords: rTMS
FIBROMYALGIA
Hamilton depression and Anxiety scale
MoCa
DLPFC
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2024-04-10
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 1- Assessment of Fibromyalgia Impact Questionnaire (FIQ)
timeFrame: 3 months
Secondary outcomes:
measure: 1-Assessment of Hamilton depression (HDRS) and Hamilton Anxiety scales (HARS) (pre- post sessions and pre post three months)
timeFrame: 3 months follow up
measure: Assessment of different cognitive rating scales (Montreal cognitive Assessment scale (MoCa), and Rey Auditory Verbal Learning Test [RAVLT],
timeFrame: 3 months follow up
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Eman Khedr
Study officials:
affiliation: Assiut University
name: Eman Khedr, professor
role: PRINCIPAL_INVESTIGATOR
References: