Non Invasive Brain Stimulation Treatment for CLBP

A Novel Non Invasive Brain Stimulation,tDCS Based Treatment for Chronic Low Back Pain (CLBP)-Sourasky Medical Center-Tel Aviv

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02615418

Acronym

NIBSTCLBP

Enrollment

Registered

2015-11-26

Start date

2016-01-31

Completion date

2017-07-31

Last updated

2015-11-30

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

Conditions

Chronic Low Back Pain (CLBP)

Brief 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.

Interventions

DEVICENIBS system for evaluation and treatment utilizing non invasive brain stimulation

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)	Baseline to week 6 .

Secondary

Measure	Time frame
Change From Baseline in Sleep Quality (0-10 Numerical Rating Scale Scores)	Baseline to 6 weeks
Change CLBP quality of life -Roland-Morris questionnaire	Baseline to 6 weeks

Contacts

Primary ContactIftach Dolev, PhD

iftach@nibs.co.il

Outcome results

None listed

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