CClinicalTrials.gg
Status unknownNCT01560039Updated Mar 21, 2012

Electroencephalography Based Neurofeedback in Chronic Neuropathic Pain

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

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Neuropathic Pain

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Keywords

  • Neuropathic pain
  • neurostimulation
03

In context

Neuralgia

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.

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Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 18-65 years old, treated medically for neuropathic pain of an upper arm with unsatisfactory results (average daily VAS score over 4)

Exclusion criteria

Exclusion Criteria:

  • Cognitive decline,
  • malignant disease,
  • focal neurological deficit,
  • illegal substance abuse
  • noncompliance with medical therapy or follow up.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Real EEG-NF

    10 EEG based neurofeedback sessions modulating the activity of the primary motor cortex

    Other: Neurofeedback

  • Sham comparator
    Sham EEG-NF

    10 sessions of Sham EEG_NF of the motor cortex area

    Other: Sham neurofeedback

  • Active comparator
    Transcrainal Magnetic Stimulation

    10 dailt TMS stimulation sessions of M1

    Device: TMS

Interventions

  • DeviceTMS

    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

  • OtherNeurofeedback

    EEG neurofeedback based on the primary motor cortex

  • OtherSham neurofeedback

    Sham EEG neurofeedback

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Functional Brain Center, Sourasky Medical Center
    Tel Aviv, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01560039
Lead sponsor
Tel-Aviv Sourasky Medical Center
Responsible party
Sponsor
First posted
Mar 21, 2012
Start date
Apr 2012
Primary completion
Apr 2013 (estimated)
Completion
Apr 2014 (estimated)
Last update
Mar 21, 2012

Study contacts

Haggai Sharon, MD
Contact
haggais@tasmc.health.gov.il
972-3-6973953
Talma Hendler, MD, PhD
study director · Sourasky Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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