WeaknessNCT01911312
Evaluation of Thermal-Aided Muscle Stimulation
A study testing Thermal-aided muscle stimulation and Body Temperature Stimulation in people with Weakness and Atrophy, run by Niveus Medical, Inc. at 1 site in United States.
Trial summary
An investigation into the relative effectiveness of thermal-aided muscle stimulation vs. body temperature muscle stimulation for eliciting muscle contraction in the quadriceps Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Thermal-aided muscle stimulation and Body Temperature Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject does not meet any exclusion criteria
Who cannot join
- Age < 18 years
- Subject is pregnant
- Subject has an implanted pacemaker/defibrillator
- Subject diagnosed with epilepsy
- Subject has implanted metallic femoral rods
- Subject is chair- or bed-bound
Show all 9Show fewer
- Subject has neuromuscular disease or abnormalities
- Subject BMI > 45
- Evidence of disease or condition that, in the opinion of the investigator, may compromise the conduct of or results of the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Melchor Pavilion
Mountain View, California, 94040
Bahman Nouri, MD, 650-962-4690
Bahman Nouri, MD
About this study
An investigation into the relative effectiveness of thermal-aided muscle stimulation vs. body temperature muscle stimulation for eliciting muscle contraction in the quadriceps
- Being tested
- Thermal-aided muscle stimulation, Body Temperature Stimulation
- Medical subject headings
- Asthenia, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal-aided muscle stimulationDevice
Thermal-aided muscle stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110
Body Temperature StimulationDevice
Body temperature stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: Thermal-aided muscle stimulation |
| Body Temperature Control | Active comparator | Stimulation performed with body temperature control Receives: Device: Body Temperature Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Contraction Force
Measured in Newtons
Measured: At 30 s intervals for 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niveus Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911312
- Sponsor's protocol ID
- CLP3.00
- Status last verified
- Jul 2013
- First submitted
- 12 Jul 2013
- Last updated
- 30 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thermal-Aided Muscle Stimulation
- ClinicalTrials.gov ID
- NCT01911312
- Acronym / sponsor ID
- CLP3.00
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Niveus Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (estimated)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An investigation into the relative effectiveness of thermal-aided muscle stimulation vs. body temperature muscle stimulation for eliciting muscle contraction in the quadriceps
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Thermal-aided muscle stimulation |
| Body Temperature Control | Active comparator | Device: Body Temperature StimulationStimulation performed with body temperature control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject does not meet any exclusion criteria
Key exclusion criteria (9 listed)
- Age < 18 years
- Subject is pregnant
- Subject has an implanted pacemaker/defibrillator
- Subject diagnosed with epilepsy
- Subject has implanted metallic femoral rods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal-aided muscle stimulationThermal-aided muscle stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110 | Device | Intervention |
| Body Temperature StimulationBody temperature stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110 | Device | Body Temperature Control |
Primary outcome
Muscle Contraction Force
Time frame: At 30 s intervals for 20 minutes
Measured in Newtons
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal-aided muscle stimulation and Body Temperature Stimulation in people with Weakness and Atrophy, run by Niveus Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian Fahey, PhD (650-336-7922, brian@niveusmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Contraction Force (time frame: At 30 s intervals for 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2013.