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Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) Sessions After a Successful 3 Week-treatment in Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rTMS
sham rTMS
Sponsored by
Centre Hospitalier Esquirol
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring rTMS, fibromyalgia, sham, maintenance session, pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • presence of the criteria from the American College of Rheumatology (2010)for fibromyalgia diagnosis,
  • painful state for more than six months,
  • visual analogic scale evaluation > or = 5,
  • age between 18 and 70,
  • no modification in therapeutic treatment one month before and during the protocol
  • presence of actual or prior antalgic chronic treatment : pregabalin, duloxetine, milnacipran, gabapentin, venlafaxine, laroxyl, grade 1 or 2 antalgic
  • residence in Limoges or the periphery, or the ability to come to the hospital for the treatment

Exclusion Criteria:

  • presence of non stabilized psychiatric comorbidity (personality trouble, addiction, suicide attempt, non controlled affective trouble),
  • active epilepsy,
  • previous cerebral traumatism, or cerebral surgery, intra-cranial hyper tension,
  • pacemaker, metallic pieces in the brain, cochlear ocular implant, or any metallic material contra indicating magnetic resonance imaging.
  • clozapine, bupropion, methadon, theophyllin, or other non chemical antalgic technic established during the previous month(kinesitherapy, relaxation, hypnosis...),
  • pregnancy, or administrative and judiciary protection, absence of health insurance.

Sites / Locations

  • Centre Hospitalier Esquirol
  • Centre Hospitalier Universitaire

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Sham Comparator

Sham Comparator

Experimental

Sham Comparator

Arm Label

rTMS-rTMS

sham - sham

rTMS-sham

rTMS

sham

Arm Description

subjects receiving real rTMS treatment and real rTMS maintenance sessions

subjects receiving sham treatment and presenting a clinical improvement : they will be submitted to sham maintenance sessions

subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment

real rTMS for 3 weeks but without clinical improvement

sham treatment for 3 weeks without clinical improvement

Outcomes

Primary Outcome Measures

number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months
= number of fibromyalgia subjects maintaining a clinical improvement after a prior rTMS treatment (15 sessions in 3 weeks)and maintenance rTMS sessions administered at 42, 63, 84, 105, 126, 147, 168, 189, 210 days after inclusion in comparison with sham maintenance sessions. clinical improvement is described as a 30% decrease from baseline in pain feeling (visual analogue scale) and a response ≥ 6 for the Patient's global impression of Change. effect will be considered as maintained if criteria of clinical improvement present after 3 week rTMS treatment are conserved at 6 months rTMS or sham maintenance sessions.

Secondary Outcome Measures

number of rTMS responders at 3week-rTMS treatment

Full Information

First Posted
September 11, 2013
Last Updated
February 11, 2019
Sponsor
Centre Hospitalier Esquirol
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1. Study Identification

Unique Protocol Identification Number
NCT01942538
Brief Title
Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) Sessions After a Successful 3 Week-treatment in Fibromyalgia
Official Title
Study of the Effectiveness of Maintenance rTMS Sessions for 6 Months Versus Placebo in Subjects With Fibromyalgia Responders to 3 Week-rTMS Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
July 28, 2017 (Actual)
Study Completion Date
July 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Esquirol

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement.
Detailed Description
In a previous pilot study, a 3 week treatment with rTMS in fibromyalgia subjects induced a 40% improvement of pain feeling. Three months later, the pain level was still significantly reduced in comparison with the beginning of the treatment, but the clinical improvement was less than at the end of the treatment. We thus propose to realize real or sham rTMS sessions at 3 weeks interval during 6 months with subjects presenting a significant clinical improvement after a 3 week-rTMS or sham treatment to evaluate the response maintenance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
rTMS, fibromyalgia, sham, maintenance session, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS-rTMS
Arm Type
Experimental
Arm Description
subjects receiving real rTMS treatment and real rTMS maintenance sessions
Arm Title
sham - sham
Arm Type
Sham Comparator
Arm Description
subjects receiving sham treatment and presenting a clinical improvement : they will be submitted to sham maintenance sessions
Arm Title
rTMS-sham
Arm Type
Sham Comparator
Arm Description
subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment
Arm Title
rTMS
Arm Type
Experimental
Arm Description
real rTMS for 3 weeks but without clinical improvement
Arm Title
sham
Arm Type
Sham Comparator
Arm Description
sham treatment for 3 weeks without clinical improvement
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
one session : 20 runs of 10 seconds high frequency stimulation(10Hz) and 50 seconds pause - power equivalent to 90% of the motor threshold
Intervention Type
Device
Intervention Name(s)
sham rTMS
Intervention Description
same session as defined with the real rTMS, but with a coil not delivering magnetic field.
Primary Outcome Measure Information:
Title
number of fibromyalgia subjects maintaining a clinical improvement with rTMS maintenance sessions during 6 months
Description
= number of fibromyalgia subjects maintaining a clinical improvement after a prior rTMS treatment (15 sessions in 3 weeks)and maintenance rTMS sessions administered at 42, 63, 84, 105, 126, 147, 168, 189, 210 days after inclusion in comparison with sham maintenance sessions. clinical improvement is described as a 30% decrease from baseline in pain feeling (visual analogue scale) and a response ≥ 6 for the Patient's global impression of Change. effect will be considered as maintained if criteria of clinical improvement present after 3 week rTMS treatment are conserved at 6 months rTMS or sham maintenance sessions.
Time Frame
210 days
Secondary Outcome Measure Information:
Title
number of rTMS responders at 3week-rTMS treatment
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: presence of the criteria from the American College of Rheumatology (2010)for fibromyalgia diagnosis, painful state for more than six months, visual analogic scale evaluation > or = 5, age between 18 and 70, no modification in therapeutic treatment one month before and during the protocol presence of actual or prior antalgic chronic treatment : pregabalin, duloxetine, milnacipran, gabapentin, venlafaxine, laroxyl, grade 1 or 2 antalgic residence in Limoges or the periphery, or the ability to come to the hospital for the treatment Exclusion Criteria: presence of non stabilized psychiatric comorbidity (personality trouble, addiction, suicide attempt, non controlled affective trouble), active epilepsy, previous cerebral traumatism, or cerebral surgery, intra-cranial hyper tension, pacemaker, metallic pieces in the brain, cochlear ocular implant, or any metallic material contra indicating magnetic resonance imaging. clozapine, bupropion, methadon, theophyllin, or other non chemical antalgic technic established during the previous month(kinesitherapy, relaxation, hypnosis...), pregnancy, or administrative and judiciary protection, absence of health insurance.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Dumont, MD
Organizational Affiliation
CHU Dupuytren CH Esquirol
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Esquirol
City
Limoges
ZIP/Postal Code
87000
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Limoges
ZIP/Postal Code
87000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
23673085
Citation
Ciobanu C, Girard M, Marin B, Labrunie A, Malauzat D. rTMS for pharmacoresistant major depression in the clinical setting of a psychiatric hospital: effectiveness and effects of age. J Affect Disord. 2013 Sep 5;150(2):677-81. doi: 10.1016/j.jad.2013.03.024. Epub 2013 May 11.
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Efficiency of Repetitive Transcranial Magnetic Stimulation (rTMS) Sessions After a Successful 3 Week-treatment in Fibromyalgia

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