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

Cervel Neurotech

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: DSF-rTMS

Study type: Interventional

Funder types: Industry

Identifiers

NCT01229852

NS-CFS-FM-1

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Active DSF-rTMS

Experimental group

Description:

Active rTMS treatment.

Treatment:

Device: DSF-rTMS