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

December 17, 2010
July 1, 2014
April 2011
February 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01308801 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 awaiking at night
Not Provided
Not Provided
 
Repetitive Transcranial Magnetic Stimulation in Fibromyalgia
Benefice Assessment of Repetitive Transcranial Magnetic Stimulation Used as an Additional Procedure to Rehabilitation Exercises in Patients Suffering From Fibromyalgia

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • 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
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
February 2016
February 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Caroline Maindet-Dominici, MD 00376765213 CMaindet-Dominici@chu-greoble.fr
France
 
NCT01308801
2010-A00865-34
No
University Hospital, Grenoble
University Hospital, Grenoble
Fondation Apicil
Principal Investigator: Caroline Maindet-Dominici, MD Centre de la Douleur CHU de Grenoble
University Hospital, Grenoble
July 2014

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