FibromyalgiaNCT01229852
Treatment of Fibromyalgia Using Deep Shaped-Field Transcranial Magnetic Stimulation a Clinical Feasibility Study
A study testing DSF-rTMS in people with Fibromyalgia, run by Cervel Neurotech, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- DSF-rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Fibromyalgia Using Deep Shaped-Field (DSF) Transcranial Magnetic Stimulation (TMS): 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.
- Conditions
- Fibromyalgia
- Being tested
- DSF-rTMS
- Keywords
- Fibromyalgia, Transcranial Magnetic Stimulation, Pain
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSF-rTMSDevice
Effective Transcranial Magnetic Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active DSF-rTMS | Experimental | Active rTMS treatment. Receives: Device: DSF-rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on the Brief Pain Inventory (BPI)
Measured: Daily during 20 day treatment
Secondary outcomes (3)
Change from Baseline on the Beck Depression Inventory Second Edition (BDI-II)
Measured: 1, 6, 10, 15 day of treatment; 1 day, 4 weeks post treatment
Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ)
Measured: 1, 10 day of treatment; 1 day and 4 weeks post treatment
Durability, safety and tolerability
Measured: Measured weekly up to 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cervel Neurotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- M. Bret Schneider, M.D., Study chair, Cervel Neurotech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229852
- Sponsor's protocol ID
- NS-CFS-FM-1
- Status last verified
- May 2014
- First submitted
- 25 Oct 2010
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Fibromyalgia Using Deep Shaped-Field (DSF) Transcranial Magnetic Stimulation (TMS): A Clinical Feasibility Study
- ClinicalTrials.gov ID
- NCT01229852
- Acronym / sponsor ID
- NS-CFS-FM-1
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia, Transcranial Magnetic Stimulation, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Cervel Neurotech, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 28 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active DSF-rTMS | Experimental | Device: DSF-rTMSActive rTMS treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DSF-rTMSEffective Transcranial Magnetic Stimulation | Device | Active DSF-rTMS |
Primary outcome
Change from Baseline on the Brief Pain Inventory (BPI)
Time frame: Daily during 20 day treatment
3 secondary outcomes
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
Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 1, 10 day of treatment; 1 day and 4 weeks post treatment
Durability, safety and tolerability
Time frame: Measured weekly up to 1 month after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
- Cervel Neurotech, Inc. HomepageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Bret Schneider, M.D. study chair
Cervel Neurotech, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSF-rTMS in people with Fibromyalgia, run by Cervel Neurotech, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on the Brief Pain Inventory (BPI) (time frame: Daily during 20 day treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014.