Non Invasive Brain Stimulation Treatment for CLBP

NCT02615418 | Unknown

• 1 other identifier: NIBS-Sour-1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Low Back Pain (CLBP)

Outcome Measures

Primary Outcomes (1)

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

  Baseline to week 6 .

Secondary Outcomes (2)

• 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

Study Arms (2)

Fully active treatement

ACTIVE COMPARATOR

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

partially active

SHAM COMPARATOR

first 2.5 weeks will receive sham treatment followed by active

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

Interventions

NIBS system for evaluation and treatment utilizing non invasive brain stimulation DEVICE

Fully active treatement; partially active

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• NIBS NeuroScience Technologies: lead

MeSH Terms

Interventions

Physical Examination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Iftach Dolev, PhD

CONTACT

iftach@nibs.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: November 26, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 30, 2015

Record last verified: 2015-11