Ignite Creation Date:
2024-05-06 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 12:41 PM
Study NCT ID:
NCT03460340
Status:
UNKNOWN
Last Update Posted:
2018-03-09
First Post:
2018-02-04
Brief Title:
dTMS as a Treatment for Patients With Fibromyalgia
Sponsor:
Shalvata Mental Health Center
Organization:
Shalvata Mental Health Center
Study Overview
Official Title:
Randomized Sham-controlled Study of Deep Transcranial Magnetic Stimulation dTMS as a Treatment for Patients With Fibromyalgia
Status:
UNKNOWN
Status Verified Date:
2018-03
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:
Purpose The purpose of the study is to explore the efficacy of H1 deep TMS for the treatment of FMS
Design Prospective randomized sham controlled trial Study Population sample sizeforty 40 FMS subjects between 18-80 years of age
No of Centers Four centers-
1 Shalvata Mental Health Center Tel -Aviv University Israel
2 Soraski medical center Tel-Aviv University Israel
3 Sheba Medical Center Tel-Aviv University Israel
4 Beer-Yakov Mental Health Center Tel-Aviv University Israel Duration and intensity of Treatment All subjects will receive prefrontal deep rTMS of H1 Coil 75 trains of 2 seconds 20 Hz with 20 seconds inter-train intervals up to 120 of motor threshold a total of 3000 pulses per session for 4 weeks 5 days a week overall 20 sessions
Name of device The Brainsway Ltd H1-Coil
Study Endpoints Clinical outcome
primary outcome Change in self-reported average pain intensity over the last 24 hours will be measured at the end point with the numerical scale 0 no pain 10 maximal pain imaginable of the VAS-FIQ
secondary outcome
1 Change of sensory and affective pain dimensions will be measured at the end point using the McGill Pain Questionnaire
2 Change of the impact of pain and FMS on quality of life will be measured at the end point using the BPI items for pain interference
3 change of sensitivity to painful stimuli will be evaluated by physical measurements
WPI
SSS
4 Changes in cognitive functions in domains of attention working memory spatial memory executive functions and social cognition will be measured at the beginning and end point of the study using the Penn Web-Based Computerized Neurocognitive Battery WebCNP
Design Prospective randomized sham controlled trial Study Population sample sizeforty 40 FMS subjects between 18-80 years of age
No of Centers Four centers-
1 Shalvata Mental Health Center Tel -Aviv University Israel
2 Soraski medical center Tel-Aviv University Israel
3 Sheba Medical Center Tel-Aviv University Israel
4 Beer-Yakov Mental Health Center Tel-Aviv University Israel Duration and intensity of Treatment All subjects will receive prefrontal deep rTMS of H1 Coil 75 trains of 2 seconds 20 Hz with 20 seconds inter-train intervals up to 120 of motor threshold a total of 3000 pulses per session for 4 weeks 5 days a week overall 20 sessions
Name of device The Brainsway Ltd H1-Coil
Study Endpoints Clinical outcome
primary outcome Change in self-reported average pain intensity over the last 24 hours will be measured at the end point with the numerical scale 0 no pain 10 maximal pain imaginable of the VAS-FIQ
secondary outcome
1 Change of sensory and affective pain dimensions will be measured at the end point using the McGill Pain Questionnaire
2 Change of the impact of pain and FMS on quality of life will be measured at the end point using the BPI items for pain interference
3 change of sensitivity to painful stimuli will be evaluated by physical measurements
WPI
SSS
4 Changes in cognitive functions in domains of attention working memory spatial memory executive functions and social cognition will be measured at the beginning and end point of the study using the Penn Web-Based Computerized Neurocognitive Battery WebCNP
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None