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

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Device: DSF-rTMS

• Registration Number: NCT01229852
• Lead Sponsor: Cervel Neurotech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-10-25
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-28
• Primary Completion: 2011-09
• Study Completion: 2011-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-15
• Last Update Posted: 2014-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active DSF-rTMS	DSF-rTMS	Active rTMS treatment.

Primary Outcome Measures

Name	Time	Method
Change from Baseline on the Brief Pain Inventory (BPI)	Daily during 20 day treatment

Secondary Outcome Measures

Name	Time	Method
Change from Baseline on the Beck Depression Inventory Second Edition (BDI-II)	1, 6, 10, 15 day of treatment; 1 day, 4 weeks post treatment
Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ)	1, 10 day of treatment; 1 day and 4 weeks post treatment
Durability, safety and tolerability	Measured weekly up to 1 month after treatment

Trial Locations

Locations (1)

Premier Research Group; 🇺🇸 Phoenix, Arizona, United States