- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04891393
The Effects of Caffeine on Human Spinal Motoneurons
April 7, 2022 updated by: Temple University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19122
- Temple University
-
-
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
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Caffeine
Single-dose, orally ingested, instant coffee.
|
Starbucks brand "Via" instant coffee.
(Caffeine Content: 3 mg / kg)
|
Placebo Comparator: Inactive Placebo
Single-dose, orally ingested, instant decaffeinated coffee (equal weight to intervention dose).
|
Starbucks brand "Via" instant decaffeinated coffee.
(Caffeine Content: 15 - 25 mg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motoneuron excitability (Delta-f)
Time Frame: Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor Unit Discharge Rate
Time Frame: Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
|
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
|
Coherence
Time Frame: Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
|
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
|
Motor Unit Recruitment Threshold
Time Frame: Measured repeatedly at set intervals; Pre-Intervention & 30, 60, 90 minutes post-Intervention
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christopher Thompson, PT, PhD, Temple University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.1152/jn.00024.2001.
- 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. doi: 10.1016/0079-6107(89)90004-7. No abstract available.
- 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.
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 (Actual)
June 1, 2021
Primary Completion (Actual)
March 28, 2022
Study Completion (Actual)
March 28, 2022
Study Registration Dates
First Submitted
May 11, 2021
First Submitted That Met QC Criteria
May 11, 2021
First Posted (Actual)
May 18, 2021
Study Record Updates
Last Update Posted (Actual)
April 8, 2022
Last Update Submitted That Met QC Criteria
April 7, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 26014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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