A Prospective Trial to Explore the Efficacy of dTMS in Subjects With Fibromyalgia

NCT02083588 | Unknown Phase 2

• 1 other identifier: FMS_01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; dTMS; pain; PFC; Subjects with Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• pain intensity - past 24h

  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.

  at baseline, and after treatment number 5, 10, 15 and 20, in addition to a final examination on follow up (two weeks after determination).

Secondary Outcomes (1)

• pain dimensions

  baseline and follow up (two weeks after determination of treatment).

Study Arms (1)

open - single arm

EXPERIMENTAL

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.

Device: dTMS

Interventions

dTMS DEVICE

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.

Also known as: The Brainsway Ltd. H1-Coil

open - single arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Concomitant medication for pain and sleep disorders will be allowed provided the dose administered had been stable for at least 2 months before enrollment and remains stable throughout the study.
• Gave informed consent for participation in the study.

You may not qualify if:

• 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 psychiatric condition - including major depression or major personality disorders according to Diagnostic and Statistical Manual of Mental Disorders-IV criteria - or a history of substance abuse will be excluded, as well as pregnant subjects.
• 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.
• Inadequate communication with the patient.
• 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.

Sponsors & Collaborators

• Shalvata Mental Health Center: lead

Study Sites (1)

Shalvata MHC

Hod Ha-sharon, Israel

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2014
• First Posted: March 11, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 11, 2014

Record last verified: 2014-03

Locations

IL (1)