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Completed

NCT Number: NCT04011670

Neuroplastic Alterations of the Motor Cortex by Caffeine

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Dr. Walter Paulus

Goettigen, Lower Saxony, 37075, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and female healthy participants between the ages of 18-45.
  • Right-handed (Oldfield 1971).
  • Free willing participation and written, informed consent of all subjects obtained prior to the start of the study.
  • Participant's weight is above 60 kg

Exclusion criteria

  • Age < 18 or > 45 years old;
  • Left hand dominant;
  • Evidence of a chronic disease or history with a disorder of the nervous system
  • History of epileptic seizures;
  • Pacemaker or deep brain stimulation;
  • Metal implants in the head region (metal used in the head region, for example, clips after the operation of an intracerebral aneurysm (vessel sacking in the region of the brain vessels), implantation of an artificial auditory canal);
  • Cerebral trauma with loss of consciousness in prehistory;
  • Existence of a serious internal (internal organs) or psychiatric (mental illness)
  • Alcohol, medication or drug addiction;
  • Receptive or global aphasia (disturbance of speech comprehension or additionally of speech);
  • Participation in another scientific or clinical study within the last 4 weeks;
  • Pregnancy
  • Breastfeeding
  • Intolerance to caffeine or coffee products
  • Participant who has abnormal heart activity from an electrocardiography (ECG) finding
  • Weight is less than 60 kg

Treatment and study plan

200 mg caffeine tablet

Other
  • 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 tablet

Other
  • 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

Primary outcomes

  1. Neuroplastic changes of the cortical areas

    Time frame: Baseline (pre-measurement), immediately after intervention, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes

    Motor cortex plasticity is measured from the changes in the amplitude of the motor evoked potentials (MEPs) at different time points. Transcranial magnetic stimulation (TMS) will be used to measure MEP amplitudes.

  2. The influence of vigilance during stimulation

    Time frame: 10 minutes

    Participant's level of vigilance is monitored from pupil diameter and pupil unrest index (PUI) using pupillometer. This measurement is carried out during 10 minutes of transcranial alternating current stimulation (tACS)

Secondary outcomes

  1. Genetic polymorphism

    Time frame: 1 year

    Brain-derived neurotrophic factor (BDNF) gene polymorphisms on cortical plasticity

Sponsors and collaborators

Lead sponsor

University Medical Center Goettingen

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 8, 2019
Registry last updated
Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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