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
  Purpose

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.


Condition Intervention
Neuropathic Pain
Device: TMS
Other: Neurofeedback
Other: Sham neurofeedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Voluntary Modulation of M1 Motor Cortex Activity Using EEG Neurofeedback for the Treatment of Resistant Chronic Neuropathic Pain - a Clinical and fMRI Study

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Real EEG-NF
10 EEG based neurofeedback sessions modulating the activity of the primary motor cortex
Other: Neurofeedback
EEG neurofeedback based on the primary motor cortex
Sham Comparator: Sham EEG-NF
10 sessions of Sham EEG_NF of the motor cortex area
Other: Sham neurofeedback
Sham EEG neurofeedback
Active Comparator: Transcrainal Magnetic Stimulation
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01560039

Contacts
Contact: Haggai Sharon, MD 972-3-6973953 haggais@tasmc.health.gov.il

Locations
Israel
Functional Brain Center, Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Study Director: Talma Hendler, MD, PhD Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01560039     History of Changes
Other Study ID Numbers: TASMS-12-HS-0577-11-TLV-CTIL
Study First Received: March 12, 2012
Last Updated: March 19, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Neuropathic pain
neurostimulation

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014