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ANTARES
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
Sponsor study identifier
interventional
54
1 country
1
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2013
Actual (reported)Study Completion
October 2014
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 5, 2013
Actual (reported)June 7, 2013
Actual (reported)September 2013
Actual (reported)October 2014
Actual (reported)Percentage reduction in the intensity of neuropathic pain.
four weeks after beginning the treatment
Presence of adverse events related to the administration of rTMS.
four weeks after beginning the treatment
rTMS with "sham" coil. Sessions will be administered 5 days a week (Monday to Friday) during two consecutive weeks.
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.
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.
A coil with similar appearance to the active coil in shape and weight, producing a similar sound artifact but without emission of a magnetic pulse is used for the control group.
Fundacion Cardiovascular de Colombia
Floridablanca, Santander Department, 0, Colombia
Landmine monitor. International Campaign to Ban Landmines. (http://www.lm.icbl.org/index.php/LM/The-Issues/FAQs). Fecha de Consulta: 22 de Julio de 2010
Walsh NE, Walsh WS. Rehabilitation of landmine victims--the ultimate challenge. Bull World Health Organ. 2003;81(9):665-70. Epub 2003 Nov 14.
Andersson N, da Sousa CP, Paredes S. Social cost of land mines in four countries: Afghanistan, Bosnia, Cambodia, and Mozambique. BMJ. 1995 Sep 16;311(7007):718-21. doi: 10.1136/bmj.311.7007.718.
Federico A Silva, Neurologist
Fundacion Cardiovascular de Colombia
54 participants (actual enrollment reported by the registry).
First Submitted
June 5, 2013
First Posted
June 7, 2013
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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Primary Completion
September 2013
Actual (reported)Study Completion
October 2014
Actual (reported)Last Updated
February 8, 2016
Record last verified: 2013-06
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