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Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation a Clinical Feasibility Study

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DSF-rTMS
Sponsored by
Cervel Neurotech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Transcranial Magnetic Stimulation, Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fibromyalgia as diagnosed by American College of Rheumatology (ACR) criteria.
  • Moderate or severe pain from fibromyalgia despite current treatment regimen.
  • Will not become pregnant during study.

Exclusion Criteria:

  • Seizure disorder.
  • Metal implants on or in brain, spinal cord, ear, eye or heart.
  • Current use of proconvulsant medications (e.g., bupropion).
  • Taking oral amitriptyline > 100 mg once daily at bedtime.
  • Nonscheduled analgesic, anticonvulsant or antidepressant medications.
  • Severe depression or suicidality.
  • Other significant psychiatric disorder.
  • Previous use of TMS.

Sites / Locations

  • Premier Research Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active DSF-rTMS

Arm Description

Active rTMS treatment.

Outcomes

Primary Outcome Measures

Change from Baseline on the Brief Pain Inventory (BPI)

Secondary Outcome Measures

Change from Baseline on the Beck Depression Inventory Second Edition (BDI-II)
Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ)
Durability, safety and tolerability

Full Information

First Posted
October 25, 2010
Last Updated
May 15, 2014
Sponsor
Cervel Neurotech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01229852
Brief Title
Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation a Clinical Feasibility Study
Official Title
Treatment of Fibromyalgia Using Deep Shaped-Field (DSF) Transcranial Magnetic Stimulation (TMS): A Clinical Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cervel Neurotech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Deep shaped-field transcranial magnetic stimulation is a new type of transcranial magnetic stimulation technology which may provide a drug-free method for treating fibromyalgia. The purpose of this study is to determine the effectiveness and the durability of effect of Deep shaped-field repetitive transcranial magnetic stimulation (rTMS) in men and women diagnosed with fibromyalgia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Transcranial Magnetic Stimulation, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active DSF-rTMS
Arm Type
Experimental
Arm Description
Active rTMS treatment.
Intervention Type
Device
Intervention Name(s)
DSF-rTMS
Intervention Description
Effective Transcranial Magnetic Stimulation
Primary Outcome Measure Information:
Title
Change from Baseline on the Brief Pain Inventory (BPI)
Time Frame
Daily during 20 day treatment
Secondary Outcome Measure Information:
Title
Change from Baseline on the Beck Depression Inventory Second Edition (BDI-II)
Time Frame
1, 6, 10, 15 day of treatment; 1 day, 4 weeks post treatment
Title
Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ)
Time Frame
1, 10 day of treatment; 1 day and 4 weeks post treatment
Title
Durability, safety and tolerability
Time Frame
Measured weekly up to 1 month after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fibromyalgia as diagnosed by American College of Rheumatology (ACR) criteria. Moderate or severe pain from fibromyalgia despite current treatment regimen. Will not become pregnant during study. Exclusion Criteria: Seizure disorder. Metal implants on or in brain, spinal cord, ear, eye or heart. Current use of proconvulsant medications (e.g., bupropion). Taking oral amitriptyline > 100 mg once daily at bedtime. Nonscheduled analgesic, anticonvulsant or antidepressant medications. Severe depression or suicidality. Other significant psychiatric disorder. Previous use of TMS.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M. Bret Schneider, M.D.
Organizational Affiliation
Cervel Neurotech, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Premier Research Group
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.cervel.com
Description
Cervel Neurotech, Inc. Homepage

Learn more about this trial

Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation a Clinical Feasibility Study

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