Non Invasive Brain Stimulation Treatment for CLBP (NIBSTCLBP)

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Low Back Pain (CLBP)
• Intervention / Treatment: Device: NIBS system for evaluation and treatment utilizing non invasive brain stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iftach Dolev, PhD; Email: iftach@nibs.co.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: NIBS NeuroScience Technologies

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: November 23, 2015
• First Submitted That Met QC Criteria: November 24, 2015
• First Posted (Estimate): November 26, 2015

Study Record Updates

• Last Update Posted (Estimate): November 30, 2015
• Last Update Submitted That Met QC Criteria: November 26, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: NIBS-Sour-1