Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Electroencephalography Based Neurofeedback in Chronic Neuropathic Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01560039
First received: March 12, 2012
Last updated: March 19, 2012
Last verified: March 2012

March 12, 2012
March 19, 2012
April 2012
April 2013   (final data collection date for primary outcome measure)
daily pain levels [ Time Frame: during three weeks of treatments ] [ Designated as safety issue: No ]
daily pain levels will be assessed using a visual assessment score (VAS) during the treament phase (lasting aproximately 3 weeks)
Same as current
Complete list of historical versions of study NCT01560039 on ClinicalTrials.gov Archive Site
Daily pain measures for one month following the last session [ Time Frame: one month following the last treatment session ] [ Designated as safety issue: No ]
Daily pain scores based on the VAS (visual-analogue scale) system will be assessed for a further one month following the last treatment session.
Same as current
Not Provided
Not Provided
 
Electroencephalography Based Neurofeedback in Chronic Neuropathic Pain
Voluntary Modulation of M1 Motor Cortex Activity Using EEG Neurofeedback for the Treatment of Resistant Chronic Neuropathic Pain - a Clinical and fMRI Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Neuropathic Pain
  • 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
  • Other: Neurofeedback
    EEG neurofeedback based on the primary motor cortex
  • Other: Sham neurofeedback
    Sham EEG neurofeedback
  • Active Comparator: Real EEG-NF
    10 EEG based neurofeedback sessions modulating the activity of the primary motor cortex
    Intervention: Other: Neurofeedback
  • Sham Comparator: Sham EEG-NF
    10 sessions of Sham EEG_NF of the motor cortex area
    Intervention: Other: Sham neurofeedback
  • Active Comparator: Transcrainal Magnetic Stimulation
    10 dailt TMS stimulation sessions of M1
    Intervention: Device: TMS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
April 2014
April 2013   (final data collection date for primary outcome measure)

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:

  • Cognitive decline,
  • malignant disease,
  • focal neurological deficit,
  • illegal substance abuse
  • noncompliance with medical therapy or follow up.
Both
18 Years to 65 Years
No
Contact: Haggai Sharon, MD 972-3-6973953 haggais@tasmc.health.gov.il
Israel
 
NCT01560039
TASMS-12-HS-0577-11-TLV-CTIL
Not Provided
Tel-Aviv Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
Not Provided
Study Director: Talma Hendler, MD, PhD Sourasky Medical Center
Tel-Aviv Sourasky Medical Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP