Non Invasive Brain Evaluation and Treatment for Neuropathic Pain

NCT ID: NCT02740062

Last Updated: 2016-04-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31

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.

Conditions

Neuropathic Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active treatment

Active tDCS treatment

Group Type: ACTIVE_COMPARATOR

NIBS system for evaluation and non invasive current stimulation

Intervention Type: DEVICE

Sham treatment

Sham tDCS treatment

Group Type: SHAM_COMPARATOR

NIBS system for evaluation and non invasive current stimulation

Intervention Type: DEVICE

Interventions

NIBS system for evaluation and non invasive current stimulation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NIBS NeuroScience Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Reuth Medical Center

Tel Aviv, Other, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Yulia Levin-Meltz

Role: CONTACT

Yulia.Levin@reuth.org.il

Facility Contacts

Yulia Levin

Role: primary

Yulia.Levin@reuth.org.il

Other Identifiers

Reuth-01

Identifier Type: -

Identifier Source: org_study_id