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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01229852

Enrollment

Registered

2010-10-28

Start date

2010-08-31

Completion date

2011-10-31

Last updated

2014-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia, Transcranial Magnetic Stimulation, Pain

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.

Interventions

DEVICEDSF-rTMS

Effective Transcranial Magnetic Stimulation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026