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Electroencephalography Based Neurofeedback in Chronic Neuropathic Pain

Primary Purpose

Neuropathic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
TMS
Neurofeedback
Sham neurofeedback
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Neuropathic pain, neurostimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Functional Brain Center, Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Arm Label

Real EEG-NF

Sham EEG-NF

Transcrainal Magnetic Stimulation

Arm Description

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

10 sessions of Sham EEG_NF of the motor cortex area

10 dailt TMS stimulation sessions of M1

Outcomes

Primary Outcome Measures

daily pain levels
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
Daily pain scores based on the VAS (visual-analogue scale) system will be assessed for a further one month following the last treatment session.

Full Information

First Posted
March 12, 2012
Last Updated
March 19, 2012
Sponsor
Tel-Aviv Sourasky Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01560039
Brief Title
Electroencephalography Based Neurofeedback in Chronic Neuropathic Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Neuropathic pain, neurostimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real EEG-NF
Arm Type
Active Comparator
Arm Description
10 EEG based neurofeedback sessions modulating the activity of the primary motor cortex
Arm Title
Sham EEG-NF
Arm Type
Sham Comparator
Arm Description
10 sessions of Sham EEG_NF of the motor cortex area
Arm Title
Transcrainal Magnetic Stimulation
Arm Type
Active Comparator
Arm Description
10 dailt TMS stimulation sessions of M1
Intervention Type
Device
Intervention Name(s)
TMS
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Neurofeedback
Intervention Description
EEG neurofeedback based on the primary motor cortex
Intervention Type
Other
Intervention Name(s)
Sham neurofeedback
Intervention Description
Sham EEG neurofeedback
Primary Outcome Measure Information:
Title
daily pain levels
Description
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 Outcome Measure Information:
Title
Daily pain measures for one month following the last session
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haggai Sharon, MD
Phone
972-3-6973953
Email
haggais@tasmc.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talma Hendler, MD, PhD
Organizational Affiliation
Sourasky Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Functional Brain Center, Sourasky Medical Center
City
Tel Aviv
Country
Israel

12. IPD Sharing Statement

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Electroencephalography Based Neurofeedback in Chronic Neuropathic Pain

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