NCT02506699

Brief Summary

For ten years, rTMS, repetitive transcranial magnetic stimulation of the motor cortex, has found its place in the treatment of drug-resistant neuropathic pain. Patients relieved by some sessions may thereafter receive a chronic invasive stimulation via electrodes implanted through a neurosurgical procedure. This is common practice at the University Hospital of Caen and in different CHU with the proper equipment rTMS. It seems permissible to provide in our center only a non-invasive technique for patients challenged with brain surgery, since according to the various meta-analyzes the analgesic efficacy of rTMS seems to be correlated to the repetition of sessions. Assessment centers and the treatment of pain allow a multidimensional assessment, bio-psycho-social of patients in order to optimize their management and experience efficiently analgesics first- and second-line. We propose a study evaluating the analgesic efficacy of rTMS, in relevant stimulation parameters reproduced according to a literature review, during 3 months after 5 active sessions separated by one week apart, in 15 patients with neuropathic pain chronic refractory to treatment of first and second line, followed by multidisciplinary center specializing in chronic pain Lower Normandy. The quality of life will also be assessed by validated scales, and the results will be compared to the literature data.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

2.3 years

First QC Date

July 22, 2015

Last Update Submit

July 22, 2015

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • NPSI (Neuropathic Pain Symptom Inventory)

    Analysis of analgesic efficacy: evolution of NPSI (Neuropathic Pain Symptom Inventory), validated scale in monitoring neuropathic pain, and VAS (visual analogue scale), to fill once a week over a period of 17 weeks, from one week before the first session of rTMS until three months after the last rTMS session.

    baseline and after 17 weeks

Study Arms (1)

analgesic effect of rTMS

Observe the analgesic effect of rTMS, reference method of noninvasive stimulation of the motor cortex validated by data from the literature and current practice, after 5 separate sessions a week apart, patients with neuropathic pain chronic, refractory to first and second-line treatments proposed in a multidisciplinary center specializing in chronic pain Lower Normandy.

Other: analgesic effect of rTMS

Interventions

analgesic effect of rTMSOTHER
analgesic effect of rTMS

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic Neuropathic Pain

You may qualify if:

  • Patient 18 to 70 years with:
  • Pain lasting for more than six months;
  • Monitoring in CETD in Normandy;
  • Having had a bio-psycho-social assessment and have been the subject of a multidisciplinary discussions recorded in the medical record;
  • Presenting unilateral neuropathic pain, central or peripheral origin:
  • may affect the face,
  • upper limb,
  • or hémicorps but including at least the upper limb;
  • With neuropathic pain screening test positive (≥ DN4 4/10);
  • etiology objectified by further examinations (MRI, scanner, or EMG, PES MEP);
  • Resistant to usual treatments: less than 50% improvement compared to the initial pain (EN or EVA) in patients who received an effective dose for treatment of first and a second intention.

You may not qualify if:

  • Contraindications of rTMS:
  • Brain implanted ferromagnetic material,
  • Implanted neurostimulator (cortical and deep brain, spinal cord)
  • Cochlear Implants
  • Active epilepsy (seizures despite existence of a current treatment)
  • Pacemakers
  • Hearing loss or current taking ototoxic drugs (aminoglycosides, cisplatin)
  • Pregnancy, breastfeeding, lack of effective contraception for patients of childbearing age
  • Psychiatric illness decompensated
  • Cancer pain and post-chemotherapy
  • severe cognitive disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'évaluation et de traitement de la douleur (CETD)

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2015

First Posted

July 23, 2015

Study Start

June 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

FR(1)