Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation a Clinical Feasibility Study
This study has been completed.
Sponsor:
Cervel Neurotech, Inc.
Information provided by (Responsible Party):
Cervel Neurotech, Inc.
ClinicalTrials.gov Identifier:
NCT01229852
First received: October 25, 2010
Last updated: October 4, 2011
Last verified: October 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fibromyalgia |
Device: DSF-rTMS |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Fibromyalgia Using Deep Shaped-Field (DSF) Transcranial Magnetic Stimulation (TMS): A Clinical Feasibility Study |
Resource links provided by NLM:
Further study details as provided by Cervel Neurotech, Inc.:
Primary Outcome Measures:
- Change from Baseline on the Brief Pain Inventory (BPI) [ Time Frame: Daily during 20 day treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: 1, 10 day of treatment; 1 day and 4 weeks post treatment ] [ Designated as safety issue: No ]
- Durability, safety and tolerability [ Time Frame: Measured weekly up to 1 month after treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 42 |
| Study Start Date: | August 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Active DSF-rTMS |
Device: DSF-rTMS
Effective Transcranial Magnetic Stimulation
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Cervel Neurotech, Inc. |
| ClinicalTrials.gov Identifier: | NCT01229852 History of Changes |
| Other Study ID Numbers: | NS-CFS-FM-1 |
| Study First Received: | October 25, 2010 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cervel Neurotech, Inc.:
|
Fibromyalgia Transcranial Magnetic Stimulation Pain |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013