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

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Efficacy of Transcranial Magnetic Stimulation (TMS) in Chronic Idiopathic Pain Disorders
Verified by Hôpital Ambroise Paré, August 2009
First Received: September 8, 2006 Last Updated: August 3, 2009

Purpose

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 on the patient's self diaries. 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 rTMS will be performed on the right cortical area corresponding to the contralateral arm, 5 consecutive days , then once a week during 3 weeks then twice a month during 2 months, then once a month during 1 year. 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.

Condition: Fibromyalgia, Irritable Bowel Syndrome, Burning Mouth Syndrome
Intervention: Device: Repetitive transcranial magnetic stimulation
Phase: Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:
Efficacy of Repetitive Transcranial Magnetic Stimulation in the Treatment of Chronic Idiopathic Pain Syndromes : a Double Blind Sham Controlled Study

Further study details as provided by Hôpital Ambroise Paré:

Primary Outcome Measures:

* Weekly average of 7 daily pain scores (mean pain, maximal pain) as assessed by patient" self diary throughout the study [ Time Frame: every week ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

* Maximal, minimal and average pain scores at each assessment visit as measured with the Brief Pain Inventory [ Time Frame: at 1, 3, 6 months and one year ] [ Designated as safety issue: No ]
* Sensory and affective pain scores (McGill pain questionnaire) [ Time Frame: at 1, 3, 6 months and 1 year ] [ Designated as safety issue: No ]
* Quality of life (SF 36 scale and brief pain inventory) [ Time Frame: at 1, 3, 6 months and 1 year ] [ Designated as safety issue: No ]
* Sleep (MOS sleep) [ Time Frame: at 1, 3, 6 months and 1 year ] [ Designated as safety issue: No ]
* Disability (Dallas pain questionnaire, FIQ) [ Time Frame: at 1, 3, 6 months and 1 year ] [ Designated as safety issue: No ]
* Comorbidities (HAD) [ Time Frame: at 1, 3, 6 months and 1 year ] [ Designated as safety issue: No ]
* Catastrophizing (PCS) [ Time Frame: at 1, 3, 6 months and 1 year ] [ Designated as safety issue: No ]
* Predictors of the response based on psychological factors [ Time Frame: at inclusion ] [ Designated as safety issue: No ]
* Safety including cognitive evaluation [ Time Frame: at 6 months and 1 year (cognitive evaluation) ; safety assessed every month for up to 12 months ] [ Designated as safety issue: Yes ]
* Comparison of the efficacy of TMS between 3 different pain disorders [ Time Frame: at 6 months and 1 year ] [ Designated as safety issue: No ]


Estimated Enrollment: 90
Study Start Date: October 2006
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Repetitive transcranial magnetic stimulation: Experimental
Repetitive noninvasive transcranial magnetic stimulation of the motor cortex
Device: Repetitive transcranial magnetic stimulation
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 then every month for one year
sham: Sham Comparator
non magnetic stimulator (sham stimulator)
Device: Repetitive transcranial magnetic stimulation
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 then every month for one year

Detailed Description:

Several lines of evidence suggest that fibromyalgia syndrome, Irritable Bowel syndrome (IBS) and burning mouth syndrome are chronic pain disorders affecting pain modulation. Repetitive transcranial magnetic stimulation (rTMS) is a recent, safe and non-invasive technique for stimulating the cerebral cortex, which has recently been reported to induce short term analgesic effects in patients with chronic focal pain. We have also recently shown in a double blind randomized trial, that rTMS could have short term analgesic effects in patients with fibromyalgia. Objectives : Our aim is to investigate the long term 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 on the patient's self diaries. Methods : This study will be randomized and performed in parallel groups and double blind versus sham stimulation. It will include 30 patients per pain disorder, ie 90 patients. Stimulation will be applied to the right motor area corresponding to the contralateral hand. The treatment will consist in a first period of 5 consecutive days of stimulation, followed by a stimulation once a week during 3 weeks then a stimulation twice a month during 2 months then stimulation once a month during 6 to 12 months for the patients willing to continue the study. Clinical assessment will be performed at baseline, then at 12 ± 2 days, one month, 2 months, 3 months, 6 months and one year. It will include an assessment of pain intensity and characteristics, quality of life, sleep, depression and anxiety, catastrophizing, and a brief neuropsychological evaluation (focusing on memory, attention and vigilance). In patients with fibromyalgia, the evaluation will also include specifically the number of tender points. In patients with IBS, evaluation of bowel dysfunction will also be performed.

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.

Eligibility

Ages Eligible for Study: 18 Years to 80 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

* 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
* Mean average pain score at inclusion and randomization ≥ 4/10 (numerical scale)
* Patients aged 18 years and less than 80 years
* Informed consent
* Stable antalgic treatment

Exclusion Criteria:

* 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


This study is currently recruiting participants.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374673

Contacts
Contact: Nadine ATTAL, MD, PHD 33 1 49 09 59 31 nadine.attal@apr.aphp.fr
Contact: Didier BOUHASSIRA, MD, PhD 33 1 49 09 44 34 didier.bouhassira@apr.aphp.fr

Locations
France
Hôpital Ambroise Paré Recruiting
Boulogne, France, 92100
Principal Investigator: Nadine ATTAL, MD, PhD