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

NCT01229852 | Completed

• 1 other identifier: NS-CFS-FM-1
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Transcranial Magnetic Stimulation; Pain

Outcome Measures

Primary Outcomes (1)

• Change from Baseline on the Brief Pain Inventory (BPI)

  Daily during 20 day treatment

Secondary Outcomes (3)

• 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

Study Arms (1)

Active DSF-rTMS

EXPERIMENTAL

Active rTMS treatment.

Device: DSF-rTMS

Interventions

DSF-rTMS DEVICE

Effective Transcranial Magnetic Stimulation

Active DSF-rTMS

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cervel Neurotech, Inc.: lead

Study Sites (1)

Premier Research Group

Phoenix, Arizona, 85381, United States

Location

Related Links

• Cervel Neurotech, Inc. Homepage

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 Officials

• M. Bret Schneider, M.D.

  Cervel Neurotech, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 28, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 19, 2014

Record last verified: 2014-05

Locations

US (1)