Non Invasive Brain Evaluation and Treatment for Neuropathic Pain (NIBSNP)
Primary Purpose
Neuropathic Pain
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
NIBS system for evaluation and non invasive current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain
Eligibility Criteria
Inclusion Criteria:
- Neuropathic pain diagnosis by pain physician Up to 3 months before trial onset.
- Current NPRS>4
Exclusion Criteria:
- Neurological illness causing structural brain damage (e.g. Stroke, TIA)
- Psychiatric disease
- History of loss of consciousness
- Epilepsy or epilepsy in a first degree relative
- Medical implants
- Pregnancy
Sites / Locations
- Reuth Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active treatment
Sham treatment
Arm Description
Active tDCS treatment
Sham tDCS treatment
Outcomes
Primary Outcome Measures
Change in pain as measured by VAS (visual analog scale)
VAS estimation before Treatment and 10 minutes after tDCS treatment.
Secondary Outcome Measures
Von Frey sensitivity evaluation in neuropathic area
Full Information
NCT ID
NCT02740062
First Posted
March 27, 2016
Last Updated
April 11, 2016
Sponsor
NIBS NeuroScience Technologies
1. Study Identification
Unique Protocol Identification Number
NCT02740062
Brief Title
Non Invasive Brain Evaluation and Treatment for Neuropathic Pain
Acronym
NIBSNP
Official Title
A Novel Non Invasive Brain EEG Based Evaluation and Treatment for Central Manifestation Characteristics of Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NIBS NeuroScience Technologies
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for evaluation and treatment of neuropathic pain. The NIBS system evaluates brain neuronal network activity and customizes a personalized treatment utilizing low current non invasive brain stimulation technology for neuropathic pain with central component. this is single meeting trial which includes brain activity evaluation and a single treatment and sham treatment. The goal of the study is to evaluate the central brain component of neuropathic pain subjects, and the effect of conventional tDCS treatment.
Detailed Description
Neuropathic pain is a pain which persists after nerve injury has healed and results from significant functional and structural changes in the nervous system similar to memory processes. As a result, neuropathic pain has been proposed to be "a persistence of the memory of pain and/or the inability to extinguish the memory of pain evoked by an initial inciting injury". A firm conclusion in the neurobiology of learning and memory is that different types of memory have distinct mechanisms (e.g., declarative memory vs procedural memory). A similar distinction can be made in pain: various chronic pain states have distinct central mechanisms . Accumulating evidence suggests that chronic pain is a type of nociceptive memory mediated by structural and functional plasticity in by multiple pathways at cortical, subcortical, spinal, and peripheral levels.Elucidating the basal neuronal signature of the person suffering from chronic pain enables to optimizing a treatment which in all studies was constant for all patients regardless of their basal activity
In this study participants will undergo diagnosis of the personalized central manifestation characteristics of the neuropathic pain and evaluate the efficacy of a standard, most commonly used tDCS treatment, based on the diagnosis.
for this purpose a single meeting will take place during which participants will undergo evaluation, sham treatment and standard tDCS treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active treatment
Arm Type
Active Comparator
Arm Description
Active tDCS treatment
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
Sham tDCS treatment
Intervention Type
Device
Intervention Name(s)
NIBS system for evaluation and non invasive current stimulation
Primary Outcome Measure Information:
Title
Change in pain as measured by VAS (visual analog scale)
Description
VAS estimation before Treatment and 10 minutes after tDCS treatment.
Time Frame
Before and 10 minutes after one time treatment
Secondary Outcome Measure Information:
Title
Von Frey sensitivity evaluation in neuropathic area
Time Frame
Before and 10 minutes after one time treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neuropathic pain diagnosis by pain physician Up to 3 months before trial onset.
Current NPRS>4
Exclusion Criteria:
Neurological illness causing structural brain damage (e.g. Stroke, TIA)
Psychiatric disease
History of loss of consciousness
Epilepsy or epilepsy in a first degree relative
Medical implants
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yulia Levin-Meltz
Email
Yulia.Levin@reuth.org.il
Facility Information:
Facility Name
Reuth Medical Center
City
Tel Aviv
State/Province
Other
ZIP/Postal Code
3093865
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yulia Levin
Email
Yulia.Levin@reuth.org.il
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Vatine., Prof.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Non Invasive Brain Evaluation and Treatment for Neuropathic Pain
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