Electroencephalography Based Neurofeedback in Chronic Neuropathic Pain
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- daily pain levels [during three weeks of treatments]
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 [one month following the last treatment 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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Functional Brain Center, Sourasky Medical Center | Tel Aviv | Israel |
Sponsors and Collaborators
- Tel-Aviv Sourasky Medical Center
Investigators
- Study Director: Talma Hendler, MD, PhD, Sourasky Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TASMS-12-HS-0577-11-TLV-CTIL