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dTMS as a Treatment for Patients With Fibromyalgia

NCT03460340 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-03-09

No results posted yet for this study

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

DEVICE

prefrontal deep rTMS of H1 Coil

prefrontal deep rTMS of H1 Coil

Sponsors & Collaborators

  • Shalvata Mental Health Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2019-04-30
Completion
2020-04-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03460340 on ClinicalTrials.gov