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Non Invasive Brain Stimulation Treatment for CLBP

NCT ID: NCT02615418

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Low Back Pain (CLBP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fully active treatement

Group Type ACTIVE_COMPARATOR

NIBS system for evaluation and treatment utilizing non invasive brain stimulation

Intervention Type DEVICE

partially active

first 2.5 weeks will receive sham treatment followed by active

Group Type SHAM_COMPARATOR

NIBS system for evaluation and treatment utilizing non invasive brain stimulation

Intervention Type DEVICE

Interventions

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NIBS system for evaluation and treatment utilizing non invasive brain stimulation

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NIBS NeuroScience Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Iftach Dolev, PhD

Role: CONTACT

Email: [email protected]

Other Identifiers

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NIBS-Sour-1

Identifier Type: -

Identifier Source: org_study_id