Back to resultsdTMS as a Treatment for Patients With Fibromyalgia
Primary Purpose
Studying Efficacy of dTMS in FM
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
prefrontal deep rTMS of H1 Coil
Sponsored by
About this trial
This is an interventional treatment trial for Studying Efficacy of dTMS in FM focused on measuring dTMS, Fibromyalgia
Eligibility Criteria
Inclusion Criteria:
- Age: 18-80 years.
- Patients who continue to take their administered medications or patients who stopped ineffective administered medications
- Concomitant medication for pain and sleep disorders will be allowed provided the dose administered had been stable for at least 2 weeks before enrollment and remains stable throughout the study.
- Gave informed consent for participation in the study.
Exclusion Criteria:
- Subjects will be excluded if evidence is found of inflammatory rheumatic disease, autoimmune disease, or other painful disorders that might confound assessment of FMS pain.
- Subjects diagnosed with a current primary (Axis I) psychiatric condition according to Diagnostic and Statistical Manual of Mental Disorders-IV criteria, including anxiety disorders, not including major depression or major personality disorder. Subject with a history of substance abuse and pregnant women will be excluded as well.
- History of any metal in the head (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
- History of head injury.
- History of seizure or heat convulsion.
- History of epilepsy or seizure in first degree relatives.
- History of frequent or severe headaches.
- Use of hearing aids for hearing loss.
- Known history of cochlear implants.
- History of drug abuse or alcoholism during the last year.
- Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.
- Significant difficulties in language or communication.
- Subjects declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
- Participation in current clinical study or clinical study within 30 days prior to this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
FM group
placebo group
Arm Description
patients diagnosed with Fibromyalgia receiving dTMS treatment.
patients diagnosed with Fibromyalgia receiving sham- treatment.
Outcomes
Primary Outcome Measures
change in self-reported average pain intensity over the last 24 hours
self-reported average pain intensity over the last 24 hours will be measured with numerical scale (0 = no pain, 10 = maximal pain imaginable) of the VAS-FIQ- self-reported average pain intensity scale
Secondary Outcome Measures
Change of sensory and affective pain dimensions
Change of sensory and affective pain dimensions -using the McGill Pain Questionnaire (16 items rated between 0 "not at all" - 3 "very strong")
Change of the impact of pain and FMS on quality of life
Change of the impact of pain and FMS on quality of life- using the BPI- items rated between 1 "functioning as usual" to 10 "very affected by the pain")
Changes in cognitive functions in domains of attention, working memory, spatial memory, executive functions and social cognition
Changes in cognitive functions in domains of attention, working memory, spatial memory, executive functions and social cognition - using the the Penn Web-Based Computerized Neurocognitive Battery (WebCNP).
Full Information
NCT ID
NCT03460340
First Posted
February 4, 2018
Last Updated
March 4, 2018
Sponsor
Shalvata Mental Health Center
1. Study Identification
Unique Protocol Identification Number
NCT03460340
Brief Title
dTMS as a Treatment for Patients With Fibromyalgia
Official Title
Randomized Sham-controlled Study of Deep Transcranial Magnetic Stimulation (dTMS) as a Treatment for Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shalvata Mental Health Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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 size:forty (40) FMS subjects between 18-80 years of age.
No. of Centers: Four centers-
Shalvata Mental Health Center, Tel -Aviv University, Israel.
Soraski medical center, Tel-Aviv University, Israel.
Sheba Medical Center, Tel-Aviv University, Israel
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
Change of sensory and affective pain dimensions will be measured at the end point using the McGill Pain Questionnaire.
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.
change of sensitivity to painful stimuli will be evaluated by physical measurements:
WPI
SSS
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Studying Efficacy of dTMS in FM
Keywords
dTMS, Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized control trial (RCT)
Masking
Participant
Masking Description
participants do not know if they are getting the DTMS treatment or sham.
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FM group
Arm Type
Experimental
Arm Description
patients diagnosed with Fibromyalgia receiving dTMS treatment.
Arm Title
placebo group
Arm Type
Sham Comparator
Arm Description
patients diagnosed with Fibromyalgia receiving sham- treatment.
Intervention Type
Device
Intervention Name(s)
prefrontal deep rTMS of H1 Coil
Intervention Description
prefrontal deep rTMS of H1 Coil
Primary Outcome Measure Information:
Title
change in self-reported average pain intensity over the last 24 hours
Description
self-reported average pain intensity over the last 24 hours will be measured with numerical scale (0 = no pain, 10 = maximal pain imaginable) of the VAS-FIQ- self-reported average pain intensity scale
Time Frame
at the beginning of each session, before stimulation (Subjects will undergo 5 courses per week for 4 weeks)
Secondary Outcome Measure Information:
Title
Change of sensory and affective pain dimensions
Description
Change of sensory and affective pain dimensions -using the McGill Pain Questionnaire (16 items rated between 0 "not at all" - 3 "very strong")
Time Frame
at baseline, once a week during trial period (4 weeks), and at follow-up visit (2 weeks after the end of the treatments)
Title
Change of the impact of pain and FMS on quality of life
Description
Change of the impact of pain and FMS on quality of life- using the BPI- items rated between 1 "functioning as usual" to 10 "very affected by the pain")
Time Frame
at baseline, once a week during trial period (4 weeks), and at follow-up visit (2 weeks after the end of the treatments)
Title
Changes in cognitive functions in domains of attention, working memory, spatial memory, executive functions and social cognition
Description
Changes in cognitive functions in domains of attention, working memory, spatial memory, executive functions and social cognition - using the the Penn Web-Based Computerized Neurocognitive Battery (WebCNP).
Time Frame
baseline and end point (after 4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 18-80 years.
Patients who continue to take their administered medications or patients who stopped ineffective administered medications
Concomitant medication for pain and sleep disorders will be allowed provided the dose administered had been stable for at least 2 weeks before enrollment and remains stable throughout the study.
Gave informed consent for participation in the study.
Exclusion Criteria:
Subjects will be excluded if evidence is found of inflammatory rheumatic disease, autoimmune disease, or other painful disorders that might confound assessment of FMS pain.
Subjects diagnosed with a current primary (Axis I) psychiatric condition according to Diagnostic and Statistical Manual of Mental Disorders-IV criteria, including anxiety disorders, not including major depression or major personality disorder. Subject with a history of substance abuse and pregnant women will be excluded as well.
History of any metal in the head (outside the mouth).
Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
History of head injury.
History of seizure or heat convulsion.
History of epilepsy or seizure in first degree relatives.
History of frequent or severe headaches.
Use of hearing aids for hearing loss.
Known history of cochlear implants.
History of drug abuse or alcoholism during the last year.
Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.
Significant difficulties in language or communication.
Subjects declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
Participation in current clinical study or clinical study within 30 days prior to this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uri Nitzan, MD
Phone
09-7478644
Email
urini@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yuval Bloch, MD
Phone
09-7478644
Email
yuvalbl@clalit.org.il
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
no IPD planned to be shared at this moment
Learn more about this trial
dTMS as a Treatment for Patients With Fibromyalgia
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