Treatment Resistant Disorders
Conditions
Keywords
rTMS, FIBROMYALGIA, Hamilton depression and Anxiety scale, MoCa, DLPFC
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.
Interventions
DEVICErepetitive transcranial magnetic stimulation
Parallel study: Participants are assigned to one of two groups in parallel for 3 months follow up
Sponsors
Tanta University
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1- Assessment of Fibromyalgia Impact Questionnaire (FIQ) | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 the changes (pre-post one month and pre- post three months later) of HDRS and HARS in Fibromyalgia patients. It contains 17 items (HDRS) pertaining to symptoms of depression experienced over the past week. The HARS consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety and somatic anxiety (physical complaints related to anxiety). |
| Assessment of different cognitive rating scales (Montreal cognitive Assessment scale (MoCa), and Rey Auditory Verbal Learning Test [RAVLT], | 3 months follow up | Assessment the changes of different cognitive rating scales (pre-post sessions and pre- post three months later) in fibromyalgia patients. MoCa takes 10 to 12 minutes to complete. It based on 11 questions that evaluate seven domains of cognitive function. The MoCa has a maximum score of 30, and anything below 24 is a sign of cognitive impairment. RAVLT: it consists of five presentations of a 15-word list are given, each followed by attempted recall. This is followed by a second 15-word interference list (list B), followed by recall of list A. The number of correct words summed for the Total Recall score (range = 0-75). The Delayed Recall score is the number of correct words recalled after a 30-min delay (range = 0-15). |
Countries
Egypt
Outcome results
None listed