Non Invasive Brain Evaluation and Treatment for Neuropathic Pain

Not Applicable

• Conditions: Neuropathic Pain
• Interventions: Device: NIBS system for evaluation and non invasive current stimulation

• Registration Number: NCT02740062
• Lead Sponsor: NIBS NeuroScience Technologies

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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-27
• Status Verified: 2016-04
• Study First Submitted QC: 2016-04-11
• Last Update Submitted: 2016-04-11
• Study First Posted: 2016-04-15
• Last Update Posted: 2016-04-15
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active treatment	NIBS system for evaluation and non invasive current stimulation	Active tDCS treatment
Sham treatment	NIBS system for evaluation and non invasive current stimulation	Sham tDCS treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Von Frey sensitivity evaluation in neuropathic area	Before and 10 minutes after one time treatment

Trial Locations

Locations (1)

Reuth Medical Center; 🇮🇱 Tel Aviv, Other, Israel