Clinical Trials Logo
  1. Home
  2. Fibromyalgia
  3. NCT01229852
  4. Details
NCT01229852 Clinical Trial

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

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01229852
Other study ID # NS-CFS-FM-1
Secondary ID
Status Completed
Phase N/A
First received October 25, 2010
Last updated May 15, 2014
Start date August 2010
Est. completion date October 2011

Study information
Verified date May 2014
Source Cervel Neurotech, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical 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 magnetic stimulation (rTMS) in men and women diagnosed with fibromyalgia.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date October 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• DSF-rTMS
Effective Transcranial Magnetic Stimulation

Locations
Country Name City State
United States Premier Research Group Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Cervel Neurotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline on the Brief Pain Inventory (BPI) Daily during 20 day treatment No
Secondary 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 No
Secondary Change from Baseline for the Fibromyalgia Impact Questionnaire (FIQ) 1, 10 day of treatment; 1 day and 4 weeks post treatment No
Secondary Durability, safety and tolerability Measured weekly up to 1 month after treatment Yes
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05659862 - Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia N/A
Recruiting NCT03207828 - Testing Interventions for Patients With Fibromyalgia and Depression N/A
Completed NCT03042728 - Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program N/A
Recruiting NCT06097091 - Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia N/A
Recruiting NCT04554784 - Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia N/A
Completed NCT03300635 - Metabolism, Muscle Function and Psychological Factors in Fibromyalgia N/A
Recruiting NCT06166563 - Exercise, Irritable Bowel Syndrome and Fibromyalgia N/A
Completed NCT03166995 - Postural Exercises in Women With Fibromyalgia N/A
Completed NCT03227952 - Sensory Stimulation in Fibromyalgia N/A
Recruiting NCT06237595 - Vagus Nerve Stimulation in Fibromyalgia N/A
Completed NCT01888640 - Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST) N/A
Completed NCT03641495 - Pain Education and Therapeutic Exercise for Fibromyalgia N/A
Recruiting NCT05581628 - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Active, not recruiting NCT05128162 - Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia Phase 2
Completed NCT04674878 - Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia N/A
Active, not recruiting NCT04084795 - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia N/A
Completed NCT03129906 - Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients N/A
Completed NCT05058911 - Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia N/A
Recruiting NCT04571528 - Effectiveness of VIRTUAL FIBROWALK STUDY N/A
Recruiting NCT04571853 - New Educational Tool for FM N/A

External Links