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CompletedNCT01229852Updated May 19, 2014

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

An interventional study of DSF-rTMS in Fibromyalgia, sponsored by Cervel Neurotech, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-05-19.

Sponsored by Cervel Neurotech, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fibromyalgia

Keywords

  • Fibromyalgia
  • Transcranial Magnetic Stimulation
  • Pain
03

In context

Fibromyalgia

1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.

This study's enrollment of 35 is below the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.

Browse Fibromyalgia studies →

Lead sponsor

Cervel Neurotech, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    Active DSF-rTMS

    Active rTMS treatment.

    Device: DSF-rTMS

Interventions

  • DeviceDSF-rTMS

    Effective Transcranial Magnetic Stimulation

06

What researchers measure

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

07

Study locations

1 site
  • Premier Research Group
    Phoenix, Arizona 85381, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01229852
Lead sponsor
Cervel Neurotech, Inc.
Responsible party
Sponsor
First posted
Oct 28, 2010
Start date
Aug 2010
Primary completion
Sep 2011
Completion
Oct 2011
Last update
May 19, 2014

Study contacts

M. Bret Schneider, M.D.
study chair · Cervel Neurotech, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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Cervel Neurotech, Inc.

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