Non Invasive Brain Stimulation Treatment for CLBP

Chronic Low Back Pain (CLBP) Clinical Trial

— NIBSTCLBP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02615418
• Other study ID #: NIBS-Sour-1
• Status: Not yet recruiting
• Phase: N/A
• First received: November 23, 2015
• Last updated: November 26, 2015
• Start date: January 2016
• Est. completion date: July 2017

Study information

• Verified date: November 2015
• Source: NIBS NeuroScience Technologies
• Contact: Iftach Dolev, PhD
• Email: iftach[@]nibs.co.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain (CLBP)
• Low Back Pain

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NIBS NeuroScience Technologies

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)		Baseline to week 6 .
Secondary	Change From Baseline in Sleep Quality (0-10 Numerical Rating Scale Scores)		Baseline to 6 weeks
Secondary	Change CLBP quality of life -Roland-Morris questionnaire		Baseline to 6 weeks