Efficacy of Transcranial Magnetic Stimulation (TMS) in Chronic Idiopathic Pain Disorders

NCT00374673 | Completed Phase 3

• 1 other identifier: TMS-chronic pain 1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives : To investigate the analgesic effects of repeated sessions of unilateral rTMS in patients with chronic pain syndrome due to fibromyalgia, IBS or burning mouth syndrome. Primary outcome will be numerical pain scores. Methods : The study will be randomized and performed in parallel groups and double blind versus sham stimulation, and will include 90 patients (45 patients per treatment arm). The randomization will be computerized and performed for each aetiological group separately. The rTMS will be performed on the left motor cortex, 5 consecutive days , then once a week during 3 weeks then twice a month during 2 months, then once a month during 6 months. Clinical assessment will include an assessment of pain, quality of life, sleep, depression and anxiety, catastrophizing, and a neuropsychological evaluation. Conclusion : this study should allow to determine for the first time the long term efficacy and safety of rTMS in the treatment of dysfunctional or idiopathic chronic pain syndromes which are often refractory to conventional treatments.

Conditions

Fibromyalgia; Irritable Bowel Syndrome; Burning Mouth Syndrome

Keywords

TMS; chronic pain; fibromyalgia; IBS; burning mouth syndrome; predictive factors

Outcome Measures

Primary Outcomes (1)

• Average pain over the last 24 hours at each visit -pain diary at baseline to see the stability of the measures

  Brief Pain inventory

  at each visit before the stimulation session

Secondary Outcomes (9)

• Sensory and affective pain scores (McGill pain questionnaire)

  at baseline, then day 1, 5, weeks 3, 9, and 25 after the induction phase

• Quality of life (brief pain inventory)

  at baseline, days 1, 5,weeks 3, 9, and 25 after the induction phase

• Disability ( FIQ)

  at days 1, 5, weeks 3, 9 and 25 after the induction phase

• Comorbidities (HAD)

  at week 3 7, 13, 25 after the induction phase

• Catastrophizing (PCS)

  at weeks 3, 7, 13 and 25 after the induction phase

Study Arms (2)

transcranial magnetic stimulation

EXPERIMENTAL

repetitive transcranial magnetic stimulation of the motor cortex

Device: Repetitive transcranial magnetic stimulation

placebo stimulation

SHAM COMPARATOR

repetitive placebo stimulation of the motor cortex

Device: Repetitive transcranial magnetic stimulation

Interventions

Repetitive transcranial magnetic stimulation DEVICE

Repetitive transcranial magnetic stimulation of the motor cortex (10 Hz) every day during 5 days then every week for 3 weeks then every two weeks for 2 months then every month for 3 additional months

Also known as: placebo stimulation, rTMS

placebo stimulation; transcranial magnetic stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pain related to Fibromyalgia (ACR criteria) or IBS (Rome II criteria) or burning mouth syndrome (IHS criteria 2004)
• Chronic pain for at least 6 months
• Pain for at least 4 days a week
• Patients aged 18 years and less than 80 years
• Informed consent
• Stable antalgic treatment

You may not qualify if:

• Contraindications to TMS (electroconvulsive therapy, epilepsy, head trauma, intracranial hypertension, metallic clip, pace maker, pregnancy)
• Major depression (DSM IV criteria) or psychosis
• Disorder preventing an accurate understanding of the testing and protocol
• Intermittent pain
• Pain for less than 6 months
• Other pain more severe than the pain evaluated for the trial
• Alcohol/psychoactive drugs abuse

Sponsors & Collaborators

• Hospital Ambroise Paré Paris: lead

Study Sites (1)

Hôpital Ambroise Paré

Boulogne, 92100, France

Location

MeSH Terms

Conditions

Fibromyalgia; Irritable Bowel Syndrome; Burning Mouth Syndrome; Chronic Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Nadine ATTAL, MD, PhD

  INSERM U 987 and AP-HP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical principal investigator

Study Record Dates

• First Submitted: September 8, 2006
• First Posted: September 11, 2006
• Study Start: October 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

FR (1)