Neuroplastic Alterations of the Motor Cortex by Caffeine

November 27, 2019 updated by: Prof. Dr. Walter Paulus, University Medical Center Goettingen

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxony
      • Goettigen, Lower Saxony, Germany, 37075
        • Prof. Dr. Walter Paulus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Age < 18 or > 45 years old;
  2. Left hand dominant;
  3. Evidence of a chronic disease or history with a disorder of the nervous system
  4. History of epileptic seizures;
  5. Pacemaker or deep brain stimulation;
  6. 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);
  7. Cerebral trauma with loss of consciousness in prehistory;
  8. Existence of a serious internal (internal organs) or psychiatric (mental illness)
  9. Alcohol, medication or drug addiction;
  10. Receptive or global aphasia (disturbance of speech comprehension or additionally of speech);
  11. Participation in another scientific or clinical study within the last 4 weeks;
  12. Pregnancy
  13. Breastfeeding
  14. Intolerance to caffeine or coffee products
  15. Participant who has abnormal heart activity from an electrocardiography (ECG) finding
  16. Weight is less than 60 kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Caffeine group
Participants will receive a caffeine tablet and all electrical stimulations in a random order (tACS 140 Hz at 1 mA and sham tACS). Participant's vigilance status will be monitor based on active vigilance condition or passive vigilance condition.
Other: 200 mg caffeine tablet
  • 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
PLACEBO_COMPARATOR: Placebo group
Participants will receive a placebo tablet and all electrical stimulations in a random order (tACS 140 Hz at 1 mA and sham tACS). Participant's vigilance status will be monitor based on active vigilance condition or passive vigilance condition.
Other: Non-active tablet
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (pre-measurement), immediately after intervention, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes
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)
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic polymorphism
Time Frame: 1 year
Brain-derived neurotrophic factor (BDNF) gene polymorphisms on cortical plasticity
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Goettingen

Investigators

  • Principal Investigator: Walter Paulus, University Medical Center Goettingen, Goettingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 15, 2019

Primary Completion (ACTUAL)

November 19, 2019

Study Completion (ACTUAL)

November 19, 2019

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

July 5, 2019

First Posted (ACTUAL)

July 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 27, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33/3/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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