Healthy Clinical Trial
Official title:
The Effects of Caffeine on Human Spinal Motoneurons
| 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 |
| Verified date | April 2022 |
| Source | Temple University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Temple University | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Temple University |
United States,
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
| 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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