Ignite Creation Date:
2024-05-06 @ 2:36 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02083588
Status:
UNKNOWN
Last Update Posted:
2014-03-11
First Post:
2014-02-26
Brief Title:
A Prospective Trial to Explore the Efficacy of dTMS in Subjects With Fibromyalgia
Sponsor:
Shalvata Mental Health Center
Organization:
Shalvata Mental Health Center
Study Overview
Official Title:
A Prospective Trial to Explore the Efficacy of the H1-Coil Deep Transcranial Magnetic Stimulation TMS in Subjects With Fibromyalgia
Status:
UNKNOWN
Status Verified Date:
2014-03
Last Known Status:
NOT_YET_RECRUITING
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:
Fibromyalgia Syndrome FMS is a highly prevalent condition often affecting individuals in the prime of life causing severe reduction in quality of life and productivity as well as social isolation anxiety and depression The purpose of this study is to explore the efficacy of H1 deep TMS for the treatment of FMS patients In addition the investigators attempt to assess the effect of dTMS on the perception and modulation of pain in patients suffering from FMS
Detailed Description:
Fibromyalgia Syndrome FMS is a highly prevalent condition often affecting individuals in the prime of life causing severe reduction in quality of life and productivity as well as social isolation anxiety and depression FMS has recently been estimated to affect approximately 26 of the Israeli population Over the last decade it has repeatedly been shown that Transcranial Magnetic Stimulation TMS of the primary motor cortex M1 induces an analgesic effect both in experimental pain as well as in various chronic pain conditions possibly by activating intrinsic pain-modulation systems
Thus the purpose of this study is to explore the efficacy of H1 deep TMS for the treatment of FMS patients In addition the investigators attempt to assess the effect of dTMS on the perception and modulation of pain in patients suffering from FMS
The study will take place in Shalvata Mental Health Center After receiving the hospitals BRI approval Forty FMS patients between 18-65 years of age will sign an informed consent form and be randomized to an active arm dTMS and a placebo arm sham-dTMS Twenty treatments will be delivered to each subject over a period of 4 weeks At base-line subjects will complete a series of epidemiological and clinical questionnaires assessing symptoms of FMS depression pain anxiety as well as pain sensation and modulation tests At the termination of the study and two weeks after the final treatment all questionnaires and physical measurements will be re-administered for a final assessment of post-treatment status comparison with initial status The importance of the study lies in its potential to 1 provide evidence for the efficacy of dTMS in treating patients suffering from FMS 2enhance the investigators understanding of the pathophysiology of FMS and its underlying pain perception and modulation mechanisms 3 explore the role of the Dorso-Lateral-Prefrontal-Cortex DLPC in modulating pain and as a possible target to further therapeutic interventions in FMS
Thus the purpose of this study is to explore the efficacy of H1 deep TMS for the treatment of FMS patients In addition the investigators attempt to assess the effect of dTMS on the perception and modulation of pain in patients suffering from FMS
The study will take place in Shalvata Mental Health Center After receiving the hospitals BRI approval Forty FMS patients between 18-65 years of age will sign an informed consent form and be randomized to an active arm dTMS and a placebo arm sham-dTMS Twenty treatments will be delivered to each subject over a period of 4 weeks At base-line subjects will complete a series of epidemiological and clinical questionnaires assessing symptoms of FMS depression pain anxiety as well as pain sensation and modulation tests At the termination of the study and two weeks after the final treatment all questionnaires and physical measurements will be re-administered for a final assessment of post-treatment status comparison with initial status The importance of the study lies in its potential to 1 provide evidence for the efficacy of dTMS in treating patients suffering from FMS 2enhance the investigators understanding of the pathophysiology of FMS and its underlying pain perception and modulation mechanisms 3 explore the role of the Dorso-Lateral-Prefrontal-Cortex DLPC in modulating pain and as a possible target to further therapeutic interventions in FMS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None