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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02615418
Other study ID # NIBS-Sour-1
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT02609854 - Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions N/A
Recruiting NCT06453291 - Assessment of Different Clinical Techniques to Treat Patients With Chronic Low Back Pain N/A