Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373445
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-04-09
Brief Title:
Interventional Neuromodulation in Fibromyalgia
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
Therapeutic Effect of Repetitive Transcranial Magnetic Stimulation on Sleep Disorders in Fibromyalgia Patients A Double Blinded Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was conducted on 40 eligible fibromyalgia patients with sleep disorders They were randomized to have 20 sessions of active or sham rTMS 1 Hz 120 of resting motor threshold with total 1200 pules session over the right dorsolateral prefrontal area DLPFC for 5 sessionsweek for 4 weeks All participants were subjected to baseline evaluation with Fibromyalgia Impact Questionnaire polysomnography sleep quality and sleep characteristics assessment using the Pittsburgh Sleep Quality Index and The Medical Outcomes Study Sleep Scale respectivelyFM patients were reevaluated at 1 3 months after the end of rTMS sessions
Detailed Description:
This is a prospective double randomized controlled trial that was conducted in Tanta and Assiut University hospitals during the period from 1st October 2022 to the end of March 2023 Sixty four 64 patients with fibromyalgia were recruited from outpatient clinics of Physical Medicine Rheumatology and Rehabilitation and Neuropsychiatry Departments Tanta and Assiut University Hospitals The diagnosis of fibromyalgia was done according to American College of Rheumatology criteria or other standard criteria
Twenty two cases didnt meet the inclusion and exclusion criteria were excluded 8 of them had systemic diseases 5 patients refuse to participate 4 had contraindication for magnetic stimulation and 5 cases had primary psychiatric disorders Forty two cases were eligible and allocated into one of the two groups 11 ratio active rTMS group and sham rTMS group One case from each group didnt complete the follow up study due to headache and the remaining 20 cases in each group completed the study
Each patient was subjected to history taking including age of symptoms onset and duration complete clinical and neurological examination neurological examinations Fibromyalgia Impact Questionnaire FIQ was assessed at base line Besides baseline Sleep quality and sleep characteristics assessment using the Pittsburgh Sleep Quality Index PSQI and The Medical Outcomes Study Sleep Scale MOS Sleep Scale respectively
Randomization All qualified members were haphazardly doled out to one of the two groups Assignment concealment was done utilizing serially numbered closed enigmatic envelopes Each patient was given a serial number from a computer-created randomization table and was put within the suitable group after opening the congruent closed envelope Counseling for participation was conducted before enrollment
Procedure of repetitive transcranial magnetic stimulation rTMS
Forty two fibromyalgia patients who had regular appropriate trial of medical treatment for at least 3 months underwent 20 sessions of 30 minutes duration for each session of low frequency real or active rTMS at a rate of 5 sessions per week over 4 consecutive weeks they were carried out by a qualified expert in this field The transcranial magnetic stimulation sessions were carried out using the MAGSTIM TMS equipment Company Limited Whitland wales UK The apparatus consists of a stimulator and a coil connected to the stimulator by a thick insulated cable The investigators used the figure of eight or butterfly coil Its constructed of two circular coils about 7 cm in diameter mounted next to each other
The experimental group received real rTMS as follow The intensity of the stimulus employed in treatment has used the motor threshold MT as the basic measure To determine the MT the coil is placed over the motor cortex and moved until the smallest possible impulse produces a visible movement of the thumb wrist or fingers The MT is used as a measurement index because the motor cortex is the only brain region which gives an easily detected signal muscle twitch when depolarized The main stimulation parameters were 24 trains at120 of motor threshold for 60 seconds at 1 Hz and a 45-second interval between trains The investigators subsequently provided a total of 1200 pulses at each of the 20 sessions The stimulation area was the right dorsolateral prefrontal area that was defined as the region 5 cm rostral in the same sagittal plane as the optimal site for MT production in the first dorsal interosseous
The sham rTMS group received the same protocol of active group however the coil held perpendicular to the scalp The investigator responsible for delivering rTMS had no contact with the patients ensuring a double-blind procedure
Polysomnography Evaluation
All patients at baseline on medical ttt alonebefore rTMS sessions were subjected to one night Polysomnography PSG was performed by a Nihon Kohden corporation 1-31-4 Nishiochiai Shinjuku-Ku Tokyo 161-8560Japan SN 04142 2018 The PSG involved EEG channels montages O1A2 C3A2 C4A1 and O2A1 electrooculography LOC-A1A2 and ROC-A1A2 surface tibial and submental EMGelectromyography and modified V2 lead ECG Thermal airflow sensors thermistors were utilized for nasal and oral signals and the amplifier was connected for tracheal sound appraisal Chest and abdominal endeavors were measured by double thoracoabdominal RIP respiratory inductance plethysmography belts PSG parameters Sleep latency Apnea hypopnea index Sleep efficiency Arousal index Total sleep timeTST Wake after sleep onset Wake TST N1 TST N2TST N3TST REMrapid eye movement TST PLMsperiodic limb movements index were scored by a PSG technician and interpreted by a trained expert sleep medicine physician according to The American Academy of Sleep Medicine guidelines Apneas and hypopneas were defined according to standard methods
Twenty two cases didnt meet the inclusion and exclusion criteria were excluded 8 of them had systemic diseases 5 patients refuse to participate 4 had contraindication for magnetic stimulation and 5 cases had primary psychiatric disorders Forty two cases were eligible and allocated into one of the two groups 11 ratio active rTMS group and sham rTMS group One case from each group didnt complete the follow up study due to headache and the remaining 20 cases in each group completed the study
Each patient was subjected to history taking including age of symptoms onset and duration complete clinical and neurological examination neurological examinations Fibromyalgia Impact Questionnaire FIQ was assessed at base line Besides baseline Sleep quality and sleep characteristics assessment using the Pittsburgh Sleep Quality Index PSQI and The Medical Outcomes Study Sleep Scale MOS Sleep Scale respectively
Randomization All qualified members were haphazardly doled out to one of the two groups Assignment concealment was done utilizing serially numbered closed enigmatic envelopes Each patient was given a serial number from a computer-created randomization table and was put within the suitable group after opening the congruent closed envelope Counseling for participation was conducted before enrollment
Procedure of repetitive transcranial magnetic stimulation rTMS
Forty two fibromyalgia patients who had regular appropriate trial of medical treatment for at least 3 months underwent 20 sessions of 30 minutes duration for each session of low frequency real or active rTMS at a rate of 5 sessions per week over 4 consecutive weeks they were carried out by a qualified expert in this field The transcranial magnetic stimulation sessions were carried out using the MAGSTIM TMS equipment Company Limited Whitland wales UK The apparatus consists of a stimulator and a coil connected to the stimulator by a thick insulated cable The investigators used the figure of eight or butterfly coil Its constructed of two circular coils about 7 cm in diameter mounted next to each other
The experimental group received real rTMS as follow The intensity of the stimulus employed in treatment has used the motor threshold MT as the basic measure To determine the MT the coil is placed over the motor cortex and moved until the smallest possible impulse produces a visible movement of the thumb wrist or fingers The MT is used as a measurement index because the motor cortex is the only brain region which gives an easily detected signal muscle twitch when depolarized The main stimulation parameters were 24 trains at120 of motor threshold for 60 seconds at 1 Hz and a 45-second interval between trains The investigators subsequently provided a total of 1200 pulses at each of the 20 sessions The stimulation area was the right dorsolateral prefrontal area that was defined as the region 5 cm rostral in the same sagittal plane as the optimal site for MT production in the first dorsal interosseous
The sham rTMS group received the same protocol of active group however the coil held perpendicular to the scalp The investigator responsible for delivering rTMS had no contact with the patients ensuring a double-blind procedure
Polysomnography Evaluation
All patients at baseline on medical ttt alonebefore rTMS sessions were subjected to one night Polysomnography PSG was performed by a Nihon Kohden corporation 1-31-4 Nishiochiai Shinjuku-Ku Tokyo 161-8560Japan SN 04142 2018 The PSG involved EEG channels montages O1A2 C3A2 C4A1 and O2A1 electrooculography LOC-A1A2 and ROC-A1A2 surface tibial and submental EMGelectromyography and modified V2 lead ECG Thermal airflow sensors thermistors were utilized for nasal and oral signals and the amplifier was connected for tracheal sound appraisal Chest and abdominal endeavors were measured by double thoracoabdominal RIP respiratory inductance plethysmography belts PSG parameters Sleep latency Apnea hypopnea index Sleep efficiency Arousal index Total sleep timeTST Wake after sleep onset Wake TST N1 TST N2TST N3TST REMrapid eye movement TST PLMsperiodic limb movements index were scored by a PSG technician and interpreted by a trained expert sleep medicine physician according to The American Academy of Sleep Medicine guidelines Apneas and hypopneas were defined according to standard methods
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None