Skip to main content
OpenTrials
Completed

NCT Number: NCT01229852

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Premier Research Group

Phoenix, Arizona, 85381, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DSF-rTMS

Device

Effective Transcranial Magnetic Stimulation

Primary outcomes

  1. Change from Baseline on the Brief Pain Inventory (BPI)

    Time frame: Daily during 20 day treatment

Secondary outcomes

  1. 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

  2. Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: 1, 10 day of treatment; 1 day and 4 weeks post treatment

  3. Durability, safety and tolerability

    Time frame: Measured weekly up to 1 month after treatment

Sponsors and collaborators

Lead sponsor

Cervel Neurotech, Inc.

Industry

Registry information

Official study title

Treatment of Fibromyalgia Using Deep Shaped-Field (DSF) Transcranial Magnetic Stimulation (TMS): A Clinical Feasibility Study

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 28, 2010
Registry last updated
May 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.