Validation Study in Healthy Female Volunteers: A Comparison of Two Neurotech Vital Devices Set up to Provide Different Types of Electrical Stimulation

NCT01632748 | Completed Phase 1

• 1 other identifier: BMR-12-1004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This research is being carried out in order to compare two alternative versions of the Neurotech Vital Devices which have been set up to provide two different types of stimulation. Both these devices will be fully functioning devices and the investigators want to collect information on your perception of the two alternative modes. The patient will be asked to provide feedback on both devices which will look identical. The patient will not be told in which order the units were given to them until the completion of your visit.

Conditions

Healthy Female Volunteers

Outcome Measures

Primary Outcomes (1)

• The primary objective of this validation study is to verify that the Modified Neurotech Vital Device does not elicit a pelvic floor contraction compared to the Neurotech Vital Device.

  The primary endpoint of the study is to demonstrate that no volunteers elicit a contraction of the pelvic floor muscle with the Modified Neurotech Vital Device and that all the volunteers elicit a contraction of the pelvic floor muscle with the Neurotech Vital Device. Contraction of the pelvic floor muscles will be assessed by using sonographic/real time ultrasound imaging/recording (mean of three measurements of pelvic floor displacement achieved during maximum threshold intensity electrical stimulation).

  Day1

Secondary Outcomes (1)

• The secondary objective of this validation study is to verify that the Modified Neurotech Vital Device is perceived by the volunteers as a valid treatment option in terms of sensation.

  Day1

Study Arms (2)

Modified Neurotech Vital Device

EXPERIMENTAL

Checking to observe stimulation delivered using this device

Device: Modified Neurotech Vital Device

Neurotech Vital Device

ACTIVE COMPARATOR

Checking to see if stimulation observed using this device

Device: Neurotech Vital Device

Interventions

Neurotech Vital Device DEVICE

5 minute treatment

Also known as: Modified Neurotech Vital Device

Neurotech Vital Device

Modified Neurotech Vital Device DEVICE

5 minute stimulation

Modified Neurotech Vital Device

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are female and at least 18 years of age.
• Subjects who, in the opinion of the Investigator, are deemed healthy.
• Subjects who are able to give voluntary, written informed consent to participate in this study and from whom consent has been obtained.
• Subjects who are able to understand this study and are willing to complete all the study assessments.

You may not qualify if:

• Subjects who have a physical condition that would make them unable to perform the study procedures.
• Subjects with a history of any chronic respiratory condition (ie emphysema, chronic obstructive pulmonary disease).
• Subjects with a history of an underlying neurological condition.
• Subjects with a history of low back pain involving the spinal nerve root.
• Subjects with a blood clotting disorder or who are taking anti-coagulant medications.
• Subjects who have previously had any uro-gynaecological related surgery excluding hysterectomy.
• Subjects with a clinical diagnosis of prolapse greater than Stage 2.
• Subjects who are pregnant or could be pregnant.
• Subjects who are less than 6 months post-partum or who are lactating.
• Subjects who have any intra-uterine devices or metal implants in the pelvic area, including hip and lumbar spine.
• Subjects with pelvic pain or fibromyalgia or paravaginal defect.
• Subjects with an active implanted medical device (ie pacemaker, pump etc).
• Subjects with a history of heart disease or stroke.
• Subjects with a known cancer.
• Subjects with an injury or disability affecting any part of their body which will be in contact with the garment.

Sponsors & Collaborators

• Bio-Medical Research, Ltd.: lead

Study Sites (1)

North Georgia College and State University

Dahlonega, Georgia, 30597, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 3, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 21, 2012

Record last verified: 2012-06

Locations

US (1)