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

Completed · Phase 1

Conditions studied: Healthy Female Volunteers

In brief

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.

Key facts

Study ID

NCT01632748

Run by

Bio-Medical Research, Ltd.

People needed

20

Starts

2012-06-01

Expected to finish

2012-08-01

Last updated by the study team

2012-09-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

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.
• Subjects who are currently involved in any injury litigation claims.
• Subjects who have been committed to an institution by virtue of an order issued either by the courts or by an authority.
• Subjects who have participated in a clinical study in the last 3 months.

Where it is running

• North Georgia College and State University — Dahlonega, Georgia, United States

Full record on ClinicalTrials.gov

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