Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 256 for:    Recruiting, Not yet recruiting, Available Studies | Cortical

Neuroplastic Alterations of the Motor Cortex by Caffeine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011670
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Walter Paulus, University Medical Center Goettingen

Brief 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.


Condition or disease Intervention/treatment Phase
Cortical Excitability Brain Stimulation Caffeine Other: 200 mg caffeine tablet Other: Non-active tablet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 15 participants are assigned to caffeine group and another 15 are assigned to placebo group. Then, the participants who were initially in the caffeine group now be in placebo group and those who were in the placebo group were assigned to caffeine group. Finally, all participants received both placebo and caffeine
Masking: Double (Participant, Investigator)
Masking Description: A statistician prepares a randomization list. Only the pharmacist knows the medication type (caffeine or placebo) and the type of electrical stimulation. The researcher knows only the vigilance conditions (**passive or *active) . An investigator is blinded to the type of electrical stimulation and medication. In addition, all participants are naive to electrical stimulation and do not know if they receive placebo or verum drug.
Primary Purpose: Basic Science
Official Title: Neuroplastic Alterations of the Motor Cortex by Caffeine: Differences Between Caffeine and Non-caffeine Users and Influence of Vigilance During Stimulation
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Genetic polymorphism [ Time Frame: 1 year ]
    Brain-derived neurotrophic factor (BDNF) gene polymorphisms on cortical plasticity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011670


Contacts
Layout table for location contacts
Contact: Mohd Faizal Mohd Zulkifly, MClinPsych 4955139 ext 8457 faizal.zulkifly@med.uni-goettingen.de
Contact: Walter Paulus 4955139 ext 66650 wpaulus@med.uni-goettingen.de

Locations
Layout table for location information
Germany
Prof. Dr. Walter Paulus Recruiting
Goettigen, Lower Saxony, Germany, 37075
Contact: Walter Paulus    551396650      
Sponsors and Collaborators
University Medical Center Goettingen
Investigators
Layout table for investigator information
Principal Investigator: Walter Paulus University Medical Center Goettingen, Goettingen

Publications:

Layout table for additonal information
Responsible Party: Prof. Dr. Walter Paulus, Head of Department for Clinical Neurophysiology, University Medical Center Goettingen
ClinicalTrials.gov Identifier: NCT04011670     History of Changes
Other Study ID Numbers: 33/3/19
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Walter Paulus, University Medical Center Goettingen:
Plasticity
Variability
Non-invasive brain stimulation
Caffeine
Additional relevant MeSH terms:
Layout table for MeSH terms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents