Electroencephalography Based Neurofeedback in Chronic Neuropathic Pain

NCT01560039 | Unknown

• 1 other identifier: TASMS-12-HS-0577-11-TLV-CTIL
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

Neuropathic pain; neurostimulation

Outcome Measures

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)

  during three weeks of treatments

Secondary Outcomes (1)

• Daily pain measures for one month following the last session

  one month following the last treatment session

Study Arms (3)

Real EEG-NF

ACTIVE COMPARATOR

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

Other: Neurofeedback

Sham EEG-NF

SHAM COMPARATOR

10 sessions of Sham EEG\_NF of the motor cortex area

Other: Sham neurofeedback

Transcrainal Magnetic Stimulation

ACTIVE COMPARATOR

10 dailt TMS stimulation sessions of M1

Device: TMS

Interventions

TMS DEVICE

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

Transcrainal Magnetic Stimulation

Neurofeedback OTHER

EEG neurofeedback based on the primary motor cortex

Real EEG-NF

Sham neurofeedback OTHER

Sham EEG neurofeedback

Sham EEG-NF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Functional Brain Center, Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Talma Hendler, MD, PhD

  Sourasky Medical Center

  STUDY DIRECTOR

Central Study Contacts

Haggai Sharon, MD

CONTACT

972-3-6973953; haggais@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: March 21, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2014
• Last Updated: March 21, 2012

Record last verified: 2012-03

Locations

IL (1)