Non Invasive Brain Stimulation Treatment for CLBP (NIBSTCLBP)

NIBS NeuroScience Technologies

Status: Unknown

Conditions: Chronic Low Back Pain (CLBP)

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02615418

NIBS-Sour-1

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Fully active treatement

Active Comparator group

Treatment:

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

partially active

Sham Comparator group

Description:

first 2.5 weeks will receive sham treatment followed by active

Treatment:

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