dTMS as a Treatment for Patients With Fibromyalgia

Randomized Sham-controlled Study of Deep Transcranial Magnetic Stimulation (dTMS) as a Treatment for Patients With Fibromyalgia

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-

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).

Study Overview

• Status: Unknown
• Conditions: Studying Efficacy of dTMS in FM
• Intervention / Treatment: Device: prefrontal deep rTMS of H1 Coil

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FM group; patients diagnosed with Fibromyalgia receiving dTMS treatment.	Device: prefrontal deep rTMS of H1 Coil; prefrontal deep rTMS of H1 Coil
Sham Comparator: placebo group; patients diagnosed with Fibromyalgia receiving sham- treatment.	Device: prefrontal deep rTMS of H1 Coil; prefrontal deep rTMS of H1 Coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at the beginning of each session, before stimulation (Subjects will undergo 5 courses per week for 4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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")	at baseline, once a week during trial period (4 weeks), and at follow-up visit (2 weeks after the end of the treatments)
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")	at baseline, once a week during trial period (4 weeks), and at follow-up visit (2 weeks after the end of the treatments)
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).	baseline and end point (after 4 weeks)

Collaborators and Investigators

• Sponsor: Shalvata Mental Health Center

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: February 4, 2018
• First Submitted That Met QC Criteria: March 4, 2018
• First Posted (Actual): March 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 9, 2018
• Last Update Submitted That Met QC Criteria: March 4, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Fibromyalgia; dTMS
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: SHA-17-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: no IPD planned to be shared at this moment

Drug and device information, study documents

• 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