Non Invasive Brain Evaluation and Treatment for Neuropathic Pain (NIBSNP)

A Novel Non Invasive Brain EEG Based Evaluation and Treatment for Central Manifestation Characteristics of Neuropathic Pain

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.

Study Overview

• Status: Unknown
• Conditions: Neuropathic Pain
• Intervention / Treatment: Device: NIBS system for evaluation and non invasive current stimulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yulia Levin-Meltz; Email: Yulia.Levin@reuth.org.il

Study Locations

• Israel
  • Other
    • Tel Aviv, Other, Israel, 3093865
      • Recruiting
      • Reuth Medical Center
      • Contact: Yulia Levin; Email: Yulia.Levin@reuth.org.il
      • Principal Investigator: Jean-Jacques Vatine., Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active treatment; Active tDCS treatment	Device: NIBS system for evaluation and non invasive current stimulation
Sham Comparator: Sham treatment; Sham tDCS treatment	Device: NIBS system for evaluation and non invasive current stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain as measured by VAS (visual analog scale)	VAS estimation before Treatment and 10 minutes after tDCS treatment.	Before and 10 minutes after one time treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Von Frey sensitivity evaluation in neuropathic area	Before and 10 minutes after one time treatment

Collaborators and Investigators

• Sponsor: NIBS NeuroScience Technologies

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: March 27, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimate): April 15, 2016

Study Record Updates

• Last Update Posted (Estimate): April 15, 2016
• Last Update Submitted That Met QC Criteria: April 11, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: Reuth-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED