An interventional study of TMS and Neurofeedback in Neuropathic Pain, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-03-21.
Sponsored by Tel-Aviv Sourasky Medical Center · Not applicable, Interventional, and Treatment
Chronic neuropathic pain is a global health concern, affecting millions of patients worldwide. It is often extremely debilitating and poses a diagnostic and therapeutic challenge. The current mainstay of treatment is pharmacotherapy consisting of powerful analgesics combined with different classes of drugs that change nerve cell membrane properties. However, response to pharmacotherapy is often poor and mandates interventional strategies. Among the latest and most promising interventional strategies is the use of neurostimulation to targeted brain areas, specifically the primary motor cortex . Motor cortex stimulation , both invasive and noninvasive (using megnetic or electical stimulation), has emerged as a highly beneficial treatment, and is currently included in different professional guidelines for the treatment of medically refractory neuropathic pain.
A possible alternative way to achieve stimulation of the motor cortex is by using EEG based neurofeedback. This design, which is actually a Brain Computer Interface (BCI) enables the patient to voluntarily modulate the activity of a circumscribed brain area after a few training sessions. While EEG based neurofeedfback is decades old, it has never been tested in neuropathic pain patients.
This experiment is intended to compare both the clinical effects and the brain correlates of a BCI based self modulation of M1 activity and of exogenous magnetic brain stimulation in a population of patients suffering from chronic neuropathic pain of an upper limb. 15 such patients will receive a course of 10 daily magnetic stimulation sessions with stimulation of M1 as described in the literature. A further 30 patients will be divided into two groups: 15 will perform a course of 10 real BCI neurofeedback sessions modulating motor cortex activity and 15 will perform a course of 10 sham neurofeedback sessions. The participants' baseline chronic pain levels and their response to acute painful stimuli will be clinically evaluated before and after the course, and for an additional 1 month. Furthermore, before and after the course patients will be scanned using functional MRI during rest (baseline pain levels) and during acute pain. These scans are performed both to describe the neural correlates of the analgesia induced by motor cortex magnetic stimulation , and to compare the observed networks to the network effect of a BCI neurofeedback modulation of motor cortex activity.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's planned enrollment of 50 is close to the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 EEG based neurofeedback sessions modulating the activity of the primary motor cortex
Other: Neurofeedback
10 sessions of Sham EEG_NF of the motor cortex area
Other: Sham neurofeedback
10 dailt TMS stimulation sessions of M1
Device: TMS
Transcranial magentic stimulation of the motor cortex. Device Details : Model is Magstim TMS Rapid. Manufacturer : MAGSTIM CO LTD. Spring Gardens, Whitland, Carmarthenshire, Wales, U.K., SA34 0HR
EEG neurofeedback based on the primary motor cortex
Sham EEG neurofeedback
daily pain levels
daily pain levels will be assessed using a visual assessment score (VAS) during the treament phase (lasting aproximately 3 weeks)
Time frame: during three weeks of treatments
Daily pain measures for one month following the last session
Daily pain scores based on the VAS (visual-analogue scale) system will be assessed for a further one month following the last treatment session.
Time frame: one month following the last treatment session
This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tel-Aviv Sourasky Medical Center