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Repetitive Transcranial Magnetic Stimulation in Fibromyalgia (STIMALGI)

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ClinicalTrials.gov Identifier: NCT01308801
Recruitment Status : Completed
First Posted : March 4, 2011
Last Update Posted : January 18, 2016
Sponsor:
Collaborator:
Fondation Apicil
Information provided by (Responsible Party):
University Hospital, Grenoble

Tracking Information
First Submitted Date  ICMJE December 17, 2010
First Posted Date  ICMJE March 4, 2011
Last Update Posted Date January 18, 2016
Study Start Date  ICMJE April 2011
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2011)
Change from baseline in pain Visual Analog Scale (VAS) at 14 weeks of treatment [ Time Frame: Daily average VAS at baseline, week 2, week 4, week 8, week 14 ]
Patient will note down each day the VAS for the last 24 hours.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2012)
  • Change from base line in quality of life at 14 weeks and 26 weeks [ Time Frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program ]
    Fibromyalgia Impact Questionnaire (FIQ)
  • Change from base line in depression assessment at 14 weeks and 26 weeks [ Time Frame: at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program ]
    Beck Depression Inventory (BDI)
  • Change from baseline in Covi's anxiety scale [ Time Frame: at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program ]
    Covi's anxiety scale
  • Change from baseline in sleep quality at 14 weeks abd 26 weeks [ Time Frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program ]
    Number of times awaking at night
  • Change from baseline in neuromuscular fatigability at 14 weeks and 26 weeks [ Time Frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program ]
    Maximal voluntary activation level
  • Change from baseline in cardiac variability at 14 weeks and 26 weeks [ Time Frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program ]
    RMSSD values, power of spectral density HF, KF, LF/HF, alpha index (baroreflex sensitivity)
  • Evolution of the analgesic effect after the end of the program [ Time Frame: Daily average VAS at the end (14 weeks) and 26 weeks after the end of the program ]
    Patient will note down each day the VAS for the last 24 hours.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2011)
  • Change from base line in quality of life at 14 weeks and 26 weeks [ Time Frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program ]
    Fibromyalgia Impact Questionnaire (FIQ)
  • Change from base line in depression assessment at 14 weeks and 26 weeks [ Time Frame: at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program ]
    Beck Depression Inventory (BDI)
  • Change from baseline in Covi's anxiety scale [ Time Frame: at the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program ]
    Covi's anxiety scale
  • Change from baseline in sleep quality at 14 weeks abd 26 weeks [ Time Frame: At the beginning of the program, at the end (14 weeks), and 26 weeks after the end of the program ]
    Number of times awaiking at night
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repetitive Transcranial Magnetic Stimulation in Fibromyalgia
Official Title  ICMJE Benefice Assessment of Repetitive Transcranial Magnetic Stimulation Used as an Additional Procedure to Rehabilitation Exercises in Patients Suffering From Fibromyalgia
Brief Summary

The purpose of this study is to determine the analgesic effectiveness of Repetitive Transcranial Magnetic Stimulation (rTMS) used as an additional procedure to rehabilitation exercises in patient suffering from fibromyalgia.

A double blind clinical trial with two randomized parallel groups:

  • Placebo rTMS and rehabilitation exercise
  • Active rTMS and rehabilitation exercise
Detailed Description

Fibromyalgia is the most frequent chronic diffuse painful disease (3 to 4% of the general population).

Analgesic drugs are widely used in fibromyalgia, pain being the main symptom. However the effectiveness of analgesic drugs is often insufficient.

Among non-drug therapies, rehabilitation exercise plays an important role with a special interest in terms of the quality of life, strain and pain.

More recently the Transcranial Magnetic Stimulation effects have been evaluated in patients suffering from fibromyalgia with a statistically significative analgesic effect.

Both rehabilitation exercise and Transcranial Magnetic Stimulation (rTMS) have shown their respective analgesic effectiveness in fibromyalgia. It now seems important to evaluate the combination of these two therapies.

Main objective: To evaluate the analgesic effect of rTMS in fibromyalgia patients doing rehabilitation exercise.

Primary endpoint:

The evaluation methode used is a visual analog scale (VAS) of pain. Patients will note down every day VAS of over the last 24 hours.

The evolution of the VAS during the treatment period with respect to baseline, will be compared in both groups, active rTMS and placebo rTMS.

The investigators will analyze the average daily VAS for different weeks (W2, W4, W8, W14) compared to the average daily VAS at the baseline.

After a baseline period of 15 days, patients will begin sessions of rTMS and rehabilitation exercise for a period of 14 weeks.

The study is composed of three assessment visits : a baseline visit, a visit corresponding to the end of the therapy with exercise period and a last assessment visit at 26 weeks after the end of the treatment.

These visits will include clinical examination, blood test, an effort test, an orthostatic test, a resistance to fatigue test and polysomnography.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Fibromyalgia
Intervention  ICMJE
  • Device: active rTMS + rehabilitation exercise
    14 weeks program of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise
  • Device: placebo rTMS+ rehabilitation exercise
    14 week program of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise
Study Arms  ICMJE
  • Experimental: active rTMS + rehabilitation exercise
    14 weeks of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise
    Intervention: Device: active rTMS + rehabilitation exercise
  • Placebo Comparator: placebo rTMS + rehabilitation exercise
    14 weeks of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise
    Intervention: Device: placebo rTMS+ rehabilitation exercise
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2012)
42
Original Estimated Enrollment  ICMJE
 (submitted: March 3, 2011)
60
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • primary fibromyalgia according to the American College of Rheumatology
  • no contraindication to rehabilitation exercise
  • pain with VAS > 4 during at least six months
  • FIQ score > 50
  • no change in drug therapy over the last month
  • affiliation to French Health Service

Exclusion Criteria:

  • BMI > 35kg/m²
  • patient who has already benefited from rTMS
  • rTMS contraindication
  • restless legs symptom
  • patient suffering from major depression
  • patient suffering from inflammatory rheumatism, autoimmune disease, other chronic pain pathology
  • sleep apnea syndrome
  • no contraindication to rTMS or MRI
  • pregnant women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01308801
Other Study ID Numbers  ICMJE 2010-A00865-34
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Grenoble
Study Sponsor  ICMJE University Hospital, Grenoble
Collaborators  ICMJE Fondation Apicil
Investigators  ICMJE
Principal Investigator: Caroline Maindet-Dominici, MD Centre de la Douleur CHU de Grenoble
PRS Account University Hospital, Grenoble
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP