rTMS Effect on Cognitive and Psychiatric Dysfunction in Patients With Fibromyalgia

NCT06356805 | Completed DMC

• 1 other identifier: rTMS in Fibromyalgia
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment Resistant Disorders

Keywords

rTMS; FIBROMYALGIA; Hamilton depression and Anxiety scale; MoCa; DLPFC

Outcome Measures

Primary Outcomes (1)

• 1- Assessment of Fibromyalgia Impact Questionnaire (FIQ)

  Assessment of the changes (pre-post one month and pre- post three months later) in Fibromyalgia Impact Questionnaire FIQ. It is a brief 10-item self-administered instrument that takes approximately 5 minutes to complete. It has been designed to measure physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and wellbeing. The average FM patient scores about 50, severely afflicted patients are usually 70 plus.

  3 months

Secondary Outcomes (2)

• 1-Assessment of Hamilton depression (HDRS) and Hamilton Anxiety scales (HARS) (pre- post sessions and pre post three months)

  3 months follow up

• Assessment of different cognitive rating scales (Montreal cognitive Assessment scale (MoCa), and Rey Auditory Verbal Learning Test [RAVLT],

  3 months follow up

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

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

Device: repetitive transcranial magnetic stimulation

Sham rTMS

SHAM COMPARATOR

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.

Device: repetitive transcranial magnetic stimulation

Interventions

repetitive transcranial magnetic stimulation DEVICE

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

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead
• Tanta University: collaborator

Study Sites (1)

Eman Khedr

Asyut, 11517, Egypt

Location

MeSH Terms

Conditions

Fibromyalgia; Anxiety Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Eman Khedr, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of neurology/Faculty of medicine, Assiut University

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 10, 2024
• Study Start: January 10, 2023
• Primary Completion: January 30, 2024
• Study Completion: February 20, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

EG (1)