NCT02740062

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2016

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

3 months

First QC Date

March 27, 2016

Last Update Submit

April 11, 2016

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Von Frey sensitivity evaluation in neuropathic area

    Before and 10 minutes after one time treatment

Study Arms (2)

Active treatment

ACTIVE COMPARATOR

Active tDCS treatment

Device: NIBS system for evaluation and non invasive current stimulation

Sham treatment

SHAM COMPARATOR

Sham tDCS treatment

Device: NIBS system for evaluation and non invasive current stimulation

Interventions

NIBS system for evaluation and non invasive current stimulationDEVICE
Active treatmentSham treatment

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neuropathic pain diagnosis by pain physician Up to 3 months before trial onset.
  • Current NPRS\>4

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reuth Medical Center

Tel Aviv, Other, 3093865, Israel

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Yulia Levin-Meltz

CONTACT

Yulia.Levin@reuth.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2016

First Posted

April 15, 2016

Study Start

March 1, 2016

Primary Completion

June 1, 2016

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

IL(1)