Electroencephalography Based Neurofeedback in Chronic Neuropathic Pain
NCT ID: NCT01560039
Last Updated: 2012-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2012-04-30
2014-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Real EEG-NF
10 EEG based neurofeedback sessions modulating the activity of the primary motor cortex
Neurofeedback
EEG neurofeedback based on the primary motor cortex
Sham EEG-NF
10 sessions of Sham EEG\_NF of the motor cortex area
Sham neurofeedback
Sham EEG neurofeedback
Transcrainal Magnetic Stimulation
10 dailt TMS stimulation sessions of M1
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
Interventions
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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
Neurofeedback
EEG neurofeedback based on the primary motor cortex
Sham neurofeedback
Sham EEG neurofeedback
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* malignant disease,
* focal neurological deficit,
* illegal substance abuse
* noncompliance with medical therapy or follow up.
18 Years
65 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Talma Hendler, MD, PhD
Role: STUDY_DIRECTOR
Sourasky Medical Center
Locations
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Functional Brain Center, Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Other Identifiers
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TASMS-12-HS-0577-11-TLV-CTIL
Identifier Type: -
Identifier Source: org_study_id
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