Repetitive Transcranial Magnetic Stimulation in Fibromyalgia (STIMALGI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University Hospital, Grenoble
Sponsor:
Collaborator:
Fondation Apicil
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01308801
First received: December 17, 2010
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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

Condition Intervention
Fibromyalgia
Device: active rTMS + rehabilitation exercise
Device: placebo rTMS+ rehabilitation exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Benefice Assessment of Repetitive Transcranial Magnetic Stimulation Used as an Additional Procedure to Rehabilitation Exercises in Patients Suffering From Fibromyalgia

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Patient will note down each day the VAS for the last 24 hours.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patient will note down each day the VAS for the last 24 hours.


Estimated Enrollment: 42
Study Start Date: April 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: active rTMS + rehabilitation exercise
14 weeks of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise
Device: active rTMS + rehabilitation exercise
14 weeks program of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise
Placebo Comparator: placebo rTMS + rehabilitation exercise
14 weeks of placebo 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308801

Contacts
Contact: Caroline Maindet-Dominici, MD 00376765213 CMaindet-Dominici@chu-greoble.fr

Locations
France
CHU de Grenoble Recruiting
Grenoble, Isère, France, 38043
Contact: Caroline Maindet dominici, MD    00376765213    Cmaindet-dominici@chu-grenobe.fr   
Sub-Investigator: Jean-Pierre Alibeu, MD         
Sub-Investigator: Hasan Hodaj, MD         
Sub-Investigator: Anne Dumolard, MD         
Sub-Investigator: Robert Juvin, MD, PHD         
Sub-Investigator: Michel Guinot, MD         
Sub-Investigator: Bernard Wuyam, MD         
Sub-Investigator: Anne Favre-Juvin, MD         
Sub-Investigator: Patrick Levy, MD, PHD         
Sponsors and Collaborators
University Hospital, Grenoble
Fondation Apicil
Investigators
Principal Investigator: Caroline Maindet-Dominici, MD Centre de la Douleur CHU de Grenoble
  More Information

Publications:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01308801     History of Changes
Other Study ID Numbers: 2010-A00865-34
Study First Received: December 17, 2010
Last Updated: July 1, 2014
Health Authority: France : agence française de sécurité sanitaire des produits de santé (afssaps) - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:
fibromyalgia
pain
repetitive transcranial magnetic stimulation
rehabilitation exercise
quality of life

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 01, 2014