NCT00697398

Brief Summary

Fibromyalgia (FM) syndrome is a chronic pain condition.Repetitive trans-cranial magnetic stimulation (rTMS) was thus suggested in this indication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 9, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

August 28, 2014

Status Verified

January 1, 2010

Enrollment Period

2.8 years

First QC Date

June 9, 2008

Last Update Submit

August 27, 2014

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Analgesic efficiency

    36 months

Secondary Outcomes (3)

  • Additional evaluation of the pain

    36 months

  • Evaluation of the quality of life

    36 months

  • Evaluation of the tolerance of the treatment

    36 months

Study Arms (2)

1

PLACEBO COMPARATOR

Sound placebo

Other: Transcranial stimulation

2

EXPERIMENTAL

Sound

Other: Transcranial stimulation

Interventions

Transcranial stimulationOTHER

Stimulation to white

1

Eligibility Criteria

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

You may qualify if:

  • Female or male patient, aged from 18 to 65 years
  • Patient presenting a primary fibromyalgia answering the criteria of the ACR
  • At present painful patient with a digital echelle of the briefing inventory bread superior or equal to 4/10
  • Patient presenting a stable treatment since at least 1 less

You may not qualify if:

  • Patient minor
  • pregnant woman
  • women in age to procreate without contraception
  • patient deprived of freedom further to a court or administrative order
  • patient presenting a secondary fibromyalgia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Timone- Service dCentral de Biophysique et de Médecine Nucléaire

Marseille, 13385, France

Location

Related Publications (1)

  • Boyer L, Dousset A, Roussel P, Dossetto N, Cammilleri S, Piano V, Khalfa S, Mundler O, Donnet A, Guedj E. rTMS in fibromyalgia: a randomized trial evaluating QoL and its brain metabolic substrate. Neurology. 2014 Apr 8;82(14):1231-8. doi: 10.1212/WNL.0000000000000280. Epub 2014 Mar 26.

    PMID: 24670891DERIVED

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Eric Guedj, MD

    Assistance Publique des hopitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 13, 2008

Study Start

October 1, 2008

Primary Completion

August 1, 2011

Study Completion

October 1, 2011

Last Updated

August 28, 2014

Record last verified: 2010-01

Locations

FR(1)