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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04891393
Other study ID # 26014
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date March 28, 2022

Study information

Verified date April 2022
Source Temple University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the effects of orally ingested, commercially available, coffee (3 mg/kg of caffeine) on the excitability of human spinal motoneurons of the lower leg.


Description:

Recently, it has been shown that human spinal motoneurons do not simply act as a binary control system. Instead, they are regulated by intrinsic properties that can elicit lingering effects on the descending motoneuron. Caffeine, one of the world's most popular over-the-counter supplements, can potentially augment these characteristics of motoneurons. Using decomposition software and non-invasive, high-density surface electromyography, it is possible to extract the characteristics of these motoneurons. This project will utilize a double-blind, inactive-placebo controlled, crossover design study to examine and quantify the effects of caffeine on motoneuron excitability.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 28, 2022
Est. primary completion date March 28, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: ? Between 18 and 70 years of age Exclusion Criteria: - Significant neurological or orthopedic injuries, which may limit volitional torque generation in the tested muscles. - Significant change in the subjects' health or treatment in the past month. - Known history of cardiovascular pathology (to include: uncontrolled hypertension, cardiac arrhythmias) or medical restrictions to caffeine ingestion. - Allergies or dislike of coffee. - Women who are pregnant will be excluded due to potential forces at trunk from pelvic safety harness and due to potential adverse effects of caffeine on the developing child. - Women who are breastfeeding will be excluded due potential adverse effects on the breastfeeding infant from caffeine administration. - Adults unable to consent, minors, pregnant women, and prisoners will not be included.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Coffee
Starbucks brand "Via" instant coffee. (Caffeine Content: 3 mg / kg)
Decaffeinated coffee
Starbucks brand "Via" instant decaffeinated coffee. (Caffeine Content: 15 - 25 mg)

Locations

Country Name City State
United States Temple University Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Temple University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Farina D, Negro F. Accessing the neural drive to muscle and translation to neurorehabilitation technologies. IEEE Rev Biomed Eng. 2012;5:3-14. doi: 10.1109/RBME.2012.2183586. Review. — View Citation

Gorassini M, Yang JF, Siu M, Bennett DJ. Intrinsic activation of human motoneurons: possible contribution to motor unit excitation. J Neurophysiol. 2002 Apr;87(4):1850-8. — View Citation

Rosenberg JR, Amjad AM, Breeze P, Brillinger DR, Halliday DM. The Fourier approach to the identification of functional coupling between neuronal spike trains. Prog Biophys Mol Biol. 1989;53(1):1-31. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Motoneuron excitability (Delta-f) Changes in motorneuron excitability, as quantified by Delta-F values. A paired motor unit technique will be utilized (Gorassini et al., 2002). (Typically, these values range from -5 to +10). Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
Secondary Motor Unit Discharge Rate Changes in motor unit discharge rate. This is a single value that ranges from, approximately, 0 to 30. Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
Secondary Coherence Changes in coherence values. Coherence provides a normalized value of the strength of correlation in the frequency domain. The magnitude of the correlation of the Fourier transforms of two spike trains is squared producing a value between 0 and 1, with 1 corresponding to a perfect linear prediction at a particular frequency (Rosenberg et al., 1989). This will be calculated using the composite spike train (Negro & Farina, 2012) and, finally, z-transformed to allow for between-trial comparisons. Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
Secondary Motor Unit Recruitment Threshold Changes in motor unit recruitment threshold. As assessed by determining the amount of force (percentage of maximum volitional force output) needed to recruit an individual motor unit. Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
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