Treatment of Fibromyalgia Using Deep Shaped-Field Transcr... | NCT01229852

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

NCT01229852

Sponsor

Cervel Neurotech, Inc.

Status

Completed

Last Update Posted

May 19, 2014Estimated

Enrollment

35Actual

Phase

Not Applicable

Conditions

Fibromyalgia

Interventions

DSF-rTMS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Oct 25, 2010

First Submission Date that Met QC Criteria

Oct 27, 2010

First Posted Date

Oct 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2014

Last Update Posted Date

May 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active DSF-rTMS	Experimental	Active rTMS treatment.	Device: DSF-rTMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DSF-rTMS	Device	Effective Transcranial Magnetic Stimulation	Active DSF-rTMS

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
M. Bret Schneider, M.D.	Cervel Neurotech, Inc.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Premier Research Group		Phoenix	Arizona	85381	United States

Label	URL
Cervel Neurotech, Inc. Homepage	View source

Condition Browse Module

MeSH Terms

ID	Term
D005356	Fibromyalgia
D010146	Pain

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided