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Status unknownNCT02615418NIBSTCLBPUpdated Nov 30, 2015

Non Invasive Brain Stimulation Treatment for CLBP

An interventional study of NIBS system for evaluation and treatment utilizing non invasive brain stimulation in Chronic Low Back Pain (CLBP), sponsored by NIBS NeuroScience Technologies. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-11-30.

Sponsored by NIBS NeuroScience Technologies · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
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Study summary

This trial is designed to preliminary evaluate the efficacy and safety of NIBS system for treatment of chronic low back pain (CLBP) (over 6 months). The trial is of a double blind sham controlled partial crossover design and will involve 2 weekly treatments and evaluations for 6 weeks, with 6 weeks follow-up. The goal of the study is to 1. Asses the CLBP change immediate and long term effect for the trial duration and follow-up. 2. Asses quality of life improvement as measure by sleep quality and questioners. 3. Asses long term neuronal changes or lack thereof in treated and untreated subjects.

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Conditions studied

  • Chronic Low Back Pain (CLBP)
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In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 60 is close to the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

NIBS NeuroScience Technologies is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18 to 80
  • CLBP as defined by the European guidelines.
  • low back pain first week average NPRS>4.

Exclusion criteria

Exclusion Criteria:

  1. Acute low back pain (duration of less than 6 months) first week average NPRS> 4
  2. Neurological illness causing structural brain damage (e.g. Stroke, TIA)
  3. Psychiatric disease other than mood disorders
  4. Current chronic use of medications with pro-epileptic properties
  5. Known alcohol dependency
  6. Use of alcohol within the previous 24 hours
  7. History of loss of consciousness
  8. Epilepsy or epilepsy in a first degree relative
  9. Medical implants
  10. Pregnancy
  11. Illicit drug use or within the previous month
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Fully active treatement

    Device: NIBS system for evaluation and treatment utilizing non invasive brain stimulation

  • Sham comparator
    partially active

    first 2.5 weeks will receive sham treatment followed by active

    Device: NIBS system for evaluation and treatment utilizing non invasive brain stimulation

Interventions

  • DeviceNIBS system for evaluation and treatment utilizing non invasive brain stimulation
06

What researchers measure

Primary outcomes

  1. Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)

    Time frame: Baseline to week 6 .

Secondary outcomes

  1. Change From Baseline in Sleep Quality (0-10 Numerical Rating Scale Scores)

    Time frame: Baseline to 6 weeks

  2. Change CLBP quality of life -Roland-Morris questionnaire

    Time frame: Baseline to 6 weeks

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02615418
Lead sponsor
NIBS NeuroScience Technologies
Responsible party
Sponsor
First posted
Nov 26, 2015
Start date
Jan 2016
Primary completion
Jan 2017 (estimated)
Completion
Jul 2017 (estimated)
Last update
Nov 30, 2015

Study contacts

Iftach Dolev, PhD
Contact
iftach@nibs.co.il

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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