NCT03460340

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Shalvata Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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- 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).

Conditions

• Studying Efficacy of dTMS in FM

Interventions

Type	Name	Description
DEVICE	prefrontal deep rTMS of H1 Coil	prefrontal deep rTMS of H1 Coil

Timeline

• Start date: 2018-04-01
• Primary completion: 2019-04-01
• Completion: 2020-04-01
• First posted: 2018-03-09
• Last updated: 2018-03-09

Regulatory

• FDA-regulated device study