Effects of Repetitive Transcranial Magnetic Stimulation in the Treatment of Phantom Limb Pain in Landmine Victims: ANTARES

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Fundación Cardiovascular de Colombia
Sponsor:
Collaborators:
Universidad Industrial de Santander
Spaulding Rehabilitation Hospital
Information provided by (Responsible Party):
Fundación Cardiovascular de Colombia
ClinicalTrials.gov Identifier:
NCT01872481
First received: June 5, 2013
Last updated: NA
Last verified: June 2013
History: No changes posted
  Purpose

Phantom Limb Pain (PLP) is a neuropathic chronic syndrome, characterized by a painful sensation in a body part that has been amputated. The incidence of phantom limb pain is between 50-80% of all amputees, however, additional risk factors as psychological trauma, blood loss, and infection increases its incidence after a traumatic amputation in landmine victims. Satisfactory management is often difficult to achieve and different clinical trials with medical and surgical measures have yielded unsatisfactory results. The response rate with pharmacologic treatment is around 30% using conventional medication as opiates and N-methyl-D-aspartate (NMDA) receptor antagonists, which is not significantly different from response rates with placebo.

Recent case series have shown that repetitive Transcranial Magnetic Stimulation (rTMS) of the motor cortex can display an effectiveness that goes from 52% to 88% in the treatment of some refractory neurogenic pain cases which is quite superior to conventional management. However, the use of this type of treatment has not been studied in patients with phantom limb pain secondary to landmine injuries. The main objective of this trial is to evaluate the efficacy and safety of rTMS in the treatment of phantom limb pain in landmine victims.

A double blind randomized placebo-controlled clinical trial, including 54 landmine victims with PLP will be performed. At the time of enrollment, a complete medical evaluation will be performed and those patients who meet the inclusion criteria will be randomly assigned to one of two groups, to receive rTMS in series of 20 trains of 6 s in duration (54-s intertrain interval) at a stimulation rate of 10 Hz (1200 pulses) and an intensity of 90% rest motor threshold using an "active" coil or a "sham" coil. Sessions will be administered 5 days a week (Monday to Friday) during two consecutive weeks. The stimulation will be directed to the primary motor cortex contralateral to the amputated limb. Response will be evaluated by measuring the pain intensity at baseline and after each session using a visual analog scale. These measurements will be repeated 2 weeks after the end of the treatment scheme, in order to determine the duration of the analgesic effect of rTMS


Condition Intervention Phase
Phantom Limb Pain
Device: rTMS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Efficacy of Repetitive Transcranial Magnetic Stimulation in Patients Victims of Landmines With Phantom Limb Pain

Further study details as provided by Fundación Cardiovascular de Colombia:

Primary Outcome Measures:
  • Percentage reduction in the intensity of neuropathic pain. [ Time Frame: four weeks after beginning the treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Presence of adverse events related to the administration of rTMS. [ Time Frame: four weeks after beginning the treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 54
Study Start Date: June 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sham stimulation
rTMS with "sham" coil. Sessions will be administered 5 days a week (Monday to Friday) during two consecutive weeks.
Experimental: Active stimulation
rTMS in series of 20 trains of 6 s in duration (54-s intertrain interval) at a stimulation rate of 10 Hz (1200 pulses) at an intensity of 90% rest motor threshold. Sessions will be administered 5 days a week (Monday to Friday) during two consecutive weeks.
Device: rTMS
rTMS in series of 20 trains of 6 s in duration (54-s intertrain interval) at a stimulation rate of 10 Hz (1200 pulses) at an intensity of 90% rest motor threshold. Sessions will be administered 5 days a week (Monday to Friday) during two consecutive weeks.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 18 years or older
  • Amputation at any level of one lower limb by anti-personnel land mines
  • Symptoms compatible with PLP, defined as painful sensation, sensation of shooting, stabbing, boring, boring, sqeezing, throbbing and burning or paresthesia or any other pain sensation in a limb that doesn't exist anymore.
  • Willingness to participate in the study and to sign the informed consent form.

Exclusion Criteria:

  • Diagnosis of complex regional pain syndrome.
  • Any pathology that based on the judgment of the researcher that could alter the course of PLP (neoplasias, immunological disorders, etc.)
  • Previous diagnosis of cancer.
  • Renal insufficiency requiring dialysis treatment.
  • Pregnancy
  • History of epilepsy.
  • Cardiac arrhythmias.
  • Metallic prostheses in the skull.
  • History of severe head trauma.
  • Use of tricyclic antidepressants (amitriptyline, imipramine, clomipramine).
  • Use of antipsychotic medication (chlorpromazine, levomepromazine, haloperidol, clozapine, olanzapine, etc.).
  • Mentally or neurologically disabled patients that are considered not fit to approve their participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01872481

Contacts
Contact: Federico A Silva, Neurologist (57-7) 6399292 ext 255 federicosilva@fcv.org

Locations
Colombia
Fundacion Cardiovascular de Colombia Recruiting
Floridablanca, Santander, Colombia, 0
Contact: Federico A Silva, Neurologist    (57-7) 6399292 ext 255    federicosilva@fcv.org   
Sub-Investigator: Ronald G Garcia, MD, PhD         
Sub-Investigator: Martha I Dallos, MD         
Sub-Investigator: Alexander Pinzon, MD         
Sponsors and Collaborators
Fundación Cardiovascular de Colombia
Universidad Industrial de Santander
Spaulding Rehabilitation Hospital
Investigators
Study Director: Federico A Silva, Neurologist Fundacion Cardiovascular de Colombia
  More Information

Publications:

Responsible Party: Fundación Cardiovascular de Colombia
ClinicalTrials.gov Identifier: NCT01872481     History of Changes
Other Study ID Numbers: fcv195
Study First Received: June 5, 2013
Last Updated: June 5, 2013
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

Keywords provided by Fundación Cardiovascular de Colombia:
Phantom limb pain syndrome
Neuropathic pain
Antipersonnel landmines
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014