CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
200 mg caffeine tablet +1 moreother
Likely dose
200 mg caffeine tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04011670
NCT04011670N/ACompleted

Neuroplastic Alterations of the Motor Cortex by Caffeine: Differences Between Caffeine and Non-caffeine Users and Influence of Vigilance During Stimulation

University Medical Center Goettingen·interventional·Posted Jul 8, 2019·Updated Nov 29, 2019

In Brief

A clinical study evaluating 200 mg caffeine tablet and Non-active tablet for Cortical Excitability and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Caffeine is a psychostimulant drug. It acts as a competitive antagonist at adenosine receptors, which modulate cortical excitability as well. In deep brain stimulation (DBS), the production of adenosine following the release of adenosine triphosphate (ATP) explains the reduction of tremor. Binding of adenosine to adenosine A1 receptors suppresses excitatory transmission in the thalamus and hereby reduces both tremor-and DBS-induced side effects. Also, the effect of adenosine was attenuated following the administration of the 8-Cyclopentyl-1,3-dipropylxanthine (DPCPX) adenosine A1 receptor antagonist. Therefore, the presence of a receptor antagonist such as caffeine was suggested to reduce the effectiveness of deep brain stimulation (DBS) in treating tremor and other movement disorders. Based on this finding, the investigators hypothesize that the antagonistic effect of caffeine can tentatively block the excitatory effects of transcranial alternating current stimulation (tACS). The plasticity effects might differ among caffeine users and non- caffeine users depending on the availability of receptor binding sites. Apart from that, a major issue in NIBS studies including those studying motor-evoked potentials is the response variability both within and between individuals. The trial to trial variability of motor evoked potentials (MEPs) may be affected by many factors. Inherent to caffeine is its effect on vigilance. In this study, the investigator shall monitor the participant's vigilance by pupillometry to (1) better understand the factors, which might cause variability in transcranial excitability induction studies and (2) to separate the direct pharmacological effect from the indirect attentional effect of caffeine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 8, 2019
Enrollment StartJul 15, 2019
Primary CompletionNov 19, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.0 years ago

Interventions

200 mg caffeine tabletother

* Transcranial alternating current stimulation (140 Hz tACS) at 1 mA and active vigilance condition * Transcranial alternating current stimulation (140 Hz tACS) at 1 mA and passive vigilance condition * Transcranial alternating current stimulation (140 Hz tACS) sham and active vigilance condition * Transcranial alternating current stimulation (140 Hz tACS) sham and passive vigilance condition

Non-active tabletother

* Transcranial alternating current stimulation (140 Hz tACS) at 1 mA and active vigilance condition * Transcranial alternating current stimulation (140 Hz tACS) at 1 mA and passive vigilance condition * Transcranial alternating current stimulation (140 Hz tACS) sham and active vigilance condition * Transcranial alternating current stimulation (140 Hz tACS) sham and passive vigilance condition