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Non Invasive Brain Evaluation and Treatment for Neuropathic Pain

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02740062
Acronym
NIBSNP
Enrollment
30
Registered
2016-04-15
Start date
2016-03-31
Completion date
Unknown
Last updated
2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuropathic Pain

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.

Interventions

DEVICENIBS system for evaluation and non invasive current stimulation

Sponsors

NIBS NeuroScience Technologies
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Von Frey sensitivity evaluation in neuropathic areaBefore and 10 minutes after one time treatment

Countries

Israel

Contacts

Primary ContactYulia Levin-Meltz
Yulia.Levin@reuth.org.il

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026