NCT01942538

Brief Summary

Maintenance rTMS sessions after a successful 3week-rTMS treatment for subjects with fibromyalgia may maintain the clinical improvement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 16, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2017

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

3.9 years

First QC Date

September 11, 2013

Last Update Submit

February 11, 2019

Conditions

Fibromyalgia

Keywords

rTMSfibromyalgiashammaintenance sessionpain

Outcome Measures

Primary Outcomes (1)

  • 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.

    210 days

Secondary Outcomes (1)

  • number of rTMS responders at 3week-rTMS treatment

    21 days

Study Arms (5)

rTMS-rTMS

EXPERIMENTAL

subjects receiving real rTMS treatment and real rTMS maintenance sessions

Device: rTMS

sham - sham

SHAM COMPARATOR

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

Device: sham rTMS

rTMS-sham

SHAM COMPARATOR

subjects receiving sham rTMS maintenance sessions after successful real rTMS treatment

Device: rTMSDevice: sham rTMS

rTMS

EXPERIMENTAL

real rTMS for 3 weeks but without clinical improvement

Device: rTMS

sham

SHAM COMPARATOR

sham treatment for 3 weeks without clinical improvement

Device: sham rTMS

Interventions

rTMSDEVICE

one session : 20 runs of 10 seconds high frequency stimulation(10Hz) and 50 seconds pause - power equivalent to 90% of the motor threshold

rTMSrTMS-rTMSrTMS-sham
sham rTMSDEVICE

same session as defined with the real rTMS, but with a coil not delivering magnetic field.

rTMS-shamshamsham - sham

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier Esquirol

Limoges, 87000, France

Location

Centre Hospitalier Universitaire

Limoges, 87000, France

Location

Related Publications (1)

  • 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.

    PMID: 23673085BACKGROUND

MeSH Terms

Conditions

FibromyalgiaPain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jean-Christophe Dumont, MD

    CHU Dupuytren CH Esquirol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Assistant in Rheumatologia Service CHU Limoges

Study Record Dates

First Submitted

September 11, 2013

First Posted

September 16, 2013

Study Start

September 1, 2013

Primary Completion

July 28, 2017

Study Completion

July 28, 2017

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations

FR(2)