Non Invasive Brain Stimulation Treatment for CLBP | NCT02615418

Studies
Non Invasive Brain Stimulation Treatment for CLBP

NCT02615418

Sponsor

NIBS NeuroScience Technologies

Status

Unknown status

Last Update Posted

Nov 30, 2015Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Chronic Low Back Pain (CLBP)

Interventions

NIBS system for evaluation and treatment utilizing non invasive brain stimulation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Jan 2017Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Nov 23, 2015

First Submission Date that Met QC Criteria

Nov 24, 2015

First Posted Date

Nov 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2015

Last Update Posted Date

Nov 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NIBS system for evaluation and treatment utilizing non invasive brain stimulation	Device		Fully active treatement partially active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in CLBP on a 0-10 Numerical Pain Rating Scale (NPRS)		Baseline to week 6 .

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Iftach Dolev, PhD	Contact			iftach@nibs.co.il

Intervention Browse Module

MeSH Terms

ID	Term
D010808	Physical Examination

Ancestor Terms

ID	Term
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

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Browse Branches

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