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NCT05977920
Fasciculations in Healthy Adults After Consumption of Caffeine: an Ultrasound Study
NA trial testing Caffeine in Neurologic Symptoms in 50 participants. Status unknown.
22 January 2024
Quick facts
| Lead sponsor | Zurich Regional Health Center |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 50 |
| Start date | 30 June 2023 |
| Primary completion | 22 January 2024 |
| Estimated completion | 30 September 2024 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- Caffeine (caffeine) — full drug profile →
Conditions studied
- Neurologic Symptoms — all drugs for Neurologic Symptoms →
Sponsor
Zurich Regional Health Center
Who can join
Adults 18 to 50, any sex, with Neurologic Symptoms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Fasciculations are clinically defined as spontaneous intermittent contractions of a portion of muscles. Depending on associated symptoms they may be a sign of lower motor neuron disorder. The aim of this study is to investigate if fasciculations also occur in muscles after caffeine consumption and if there is a difference between the muscles of the arms and legs. The primary endpoint is detecting fasciculations in the muscles of the arms and legs after the consumption of caffeine in healthy adults (20-35 years old and 35-50 years old) Secondary endpoints of the study compares the proportions of fasciculations between two age groups (20-35 years old and 35-50 years. A population of 26 subject per group and a total of 52 subject will be recruited for the study. A sample size of 26 in each group will have 90% power to detect a difference between the two groups using a Fisher's exact test with a 0.05 two-sided significance level. Study Intervention Study participants will consume caffeine (6mg per kilogram bodyweight) before the second ultrasound screening. Using ultrasound the sternocleidomastoideus, biceps brachii, interosseus dorsalis, quadriceps femoris, gastrocnemius and abductor hallucis will be measure for 120 seconds 1o minutes before and 45 minutes after caffeine consumption. Study Duration and Schedule Estimated duration for the study will be around 6 months.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05977920 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Zurich Regional Health Center
- Last refreshed: 23 January 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05977920.
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