Neuropathic PainNIBSNPNCT02740062
Non Invasive Brain Evaluation and Treatment for Neuropathic Pain
A study testing NIBS system for evaluation and non invasive current stimulation in people with Neuropathic Pain, run by NIBS NeuroScience Technologies at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- NIBS system for evaluation and non invasive current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Neuropathic pain diagnosis by pain physician Up to 3 months before trial onset.
- Current NPRS>4
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Yulia Levin-Meltz contact
Israel1 site, 1 recruiting
- Recruiting
Reuth Medical Center
Tel Aviv, Other, 3093865
Yulia Levin, Yulia.Levin@reuth.org.il
Jean-Jacques Vatine., Prof.
About this study
Official title: 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.
Read the 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
- Being tested
- NIBS system for evaluation and non invasive current stimulation
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIBS system for evaluation and non invasive current stimulationDevice
| Study group | Role | What they receive |
|---|---|---|
| Active treatment | Active comparator | Active tDCS treatment Receives: Device: NIBS system for evaluation and non invasive current stimulation |
| Sham treatment | Sham comparator | Sham tDCS treatment Receives: Device: NIBS system for evaluation and non invasive current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain as measured by VAS (visual analog scale)
VAS estimation before Treatment and 10 minutes after tDCS treatment.
Measured: Before and 10 minutes after one time treatment
Secondary outcomes (1)
Von Frey sensitivity evaluation in neuropathic area
Measured: Before and 10 minutes after one time treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NIBS NeuroScience Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02740062
- Sponsor's protocol ID
- Reuth-01
- Acronym
- NIBSNP
- Status last verified
- Apr 2016
- First submitted
- 27 Mar 2016
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Non Invasive Brain EEG Based Evaluation and Treatment for Central Manifestation Characteristics of Neuropathic Pain
- ClinicalTrials.gov ID
- NCT02740062
- Acronym / sponsor ID
- NIBSNP / Reuth-01
- Conditions
- Neuropathic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NIBS NeuroScience TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (estimated)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment | Active comparator | Device: NIBS system for evaluation and non invasive current stimulationActive tDCS treatment |
| Sham treatment | Sham comparator | Device: NIBS system for evaluation and non invasive current stimulationSham tDCS treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Neuropathic pain diagnosis by pain physician Up to 3 months before trial onset.
- Current NPRS>4
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIBS system for evaluation and non invasive current stimulation | Device | Active treatment, Sham treatment |
Primary outcome
Change in pain as measured by VAS (visual analog scale)
Time frame: Before and 10 minutes after one time treatment
VAS estimation before Treatment and 10 minutes after tDCS treatment.
1 secondary outcome
Von Frey sensitivity evaluation in neuropathic area
Time frame: Before and 10 minutes after one time treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yulia Levin-Meltz contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIBS system for evaluation and non invasive current stimulation in people with Neuropathic Pain, run by NIBS NeuroScience Technologies at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yulia Levin-Meltz (Yulia.Levin@reuth.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain as measured by VAS (visual analog scale) (time frame: Before and 10 minutes after one time treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016; AzTrials last refreshed its copy on 7 Nov 2026.