- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01876160
Analysis of Sensory and Motor Thresholds During Transcutaneous Electrical Stimulation in Different Sexes and Ages
June 8, 2013 updated by: Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
The sensory and motor perception thresholds can influence the therapeutic effects of Transcutaneous Electrical Nerve Stimulation.
This study aimed to determine the threshold of sensory perception and the threshold of motor response in young and elderly subjects of both sexes.
Eighty healthy volunteers were evaluated; 40 women and 40 men divided into two equal groups of young and elderly subjects.
Half of the individuals in each group were stimulated with 5 and 50Hz frequency, with pulse duration of 20, 100, 400, 1000 and 3000µs applied on the flexor muscle bellies of the wrist and fingers.
The threshold of sensory perception was identified as the first sensation of increased current intensity and the threshold of motor response as the minimum muscle contraction detected.
The results were submitted to ANOVA test, followed by the Tukey test, with a significance level of 5%.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- healthy individuals
Exclusion Criteria:
- not present: previous circulatory, nervous or metabolic diseases, metal implants in areas to be studied; fracture on upper limb studied; history of pain or injury in areas to be studied.
- are not in menstrual period or a week before it
- not be making use of drugs that affect the nervous system
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: threshold of sensory perception
Eighty healthy volunteers were evaluated; 40 women and 40 men divided into two equal groups of young and elderly subjects.
Half of the individuals in each group were stimulated with 5 and 50Hz frequency, with pulse duration of 20, 100, 400, 1000 and 3000µs applied on the flexor muscle bellies of the wrist and fingers.
The threshold of sensory perception was identified as the first sensation of increased current intensity and the threshold of motor response as the minimum muscle contraction detected.
|
|
Experimental: threshold of motor response
Eighty healthy volunteers were evaluated; 40 women and 40 men divided into two equal groups of young and elderly subjects.
Half of the individuals in each group were stimulated with 5 and 50Hz frequency, with pulse duration of 20, 100, 400, 1000 and 3000µs applied on the flexor muscle bellies of the wrist and fingers.
The threshold of motor response as the minimum muscle contraction detected.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analysis of sensory thresholds
Time Frame: 1 years
|
A pulse generator was used for data collection, with constant current intensity, and the following parameters were used for current stimulation: square biphasic wave, and pulse-width varying in 20, 50, 100, 200,300, 500, 1000 and 3000µs, at a frequency of 5 or 50Hz.
During the procedure, the volunteers remained seated, with the forearm in supination, resting on a table.
The tests always initiated with 20µs pulse-width, with high intensity until the threshold of sensory perception were reached.
At this point, the intensity was reset and the procedure began again, followed by the next pulse duration, progressively evolving up to 3000µs and repeated three times with a 10-minute interval between the tests.
The procedures were carried out with a 72 hour minimum interval for different frequencies.
|
1 years
|
Analysis of Motor thresholds
Time Frame: 1 years
|
A pulse generator was used for data collection, with constant current intensity, and the following parameters were used for current stimulation: square biphasic wave, and pulse-width varying in 20, 50, 100, 200,300, 500, 1000 and 3000µs, at a frequency of 5 or 50Hz.
During the procedure, the volunteers remained seated, with the forearm in supination, resting on a table.
The tests always initiated with 20µs pulse-width, with high intensity until the threshold of motor response were reached.
At this point, the intensity was reset and the procedure began again, followed by the next pulse duration, progressively evolving up to 3000µs and repeated three times with a 10-minute interval between the tests.
The procedures were carried out with a 72 hour minimum interval for different frequencies.
|
1 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
March 1, 2013
Study Registration Dates
First Submitted
May 27, 2013
First Submitted That Met QC Criteria
June 8, 2013
First Posted (Estimate)
June 12, 2013
Study Record Updates
Last Update Posted (Estimate)
June 12, 2013
Last Update Submitted That Met QC Criteria
June 8, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- U1111-1143-6220
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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