Fasciculations in Healthy Adults After Consumption of Caffeine: an Ultrasound Study

NCT05977920 | Unknown

• 1 other identifier: 2022-02103
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurologic Symptoms

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is detecting fasciculations in the muscles of the arms and legs after the consumption of coffein in healthy adults (20-35 years old and 35-50 years old)

  We use ultrasound to detect the number of fasciculations before and after the consumption of caffeine in 6 muscles (arms and legs) to ascertain whether or not caffeine has an effect on the number fasciculations and if the muscles of either the upper or lower extremities are more involved. More details are provided in the detailed study description.

  1 year

Study Arms (1)

Only one Arm

OTHER

s. description

Other: Caffeine

Interventions

Caffeine OTHER

s. description

Only one Arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects (male/female)
• age 20-50 years old

You may not qualify if:

• Clinical neurological symptoms
• Clinical signs for Neuropathy
• Clinical signs for Myopathy
• Clinical signs for Vasculitis
• Clinical signs for heart disease
• Clinical signs for gastric or duodenal ulcera
• Any medicine

Sponsors & Collaborators

• Zurich Regional Health Center: lead

Study Sites (1)

GZO

Wetzikon, Canton of Zurich, 8620, Switzerland

RECRUITING

MeSH Terms

Conditions

Neurologic Manifestations

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• David Czell

  Zurich Regional Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Czell, MD

CONTACT

+41764217222; david.czell@hin.ch

David Czell

CONTACT

0433990507; david.czell@hin.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There is only one group.

Study Record Dates

• First Submitted: May 21, 2023
• First Posted: August 7, 2023
• Study Start: June 30, 2023
• Primary Completion: January 22, 2024
• Study Completion: September 30, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)