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Dopamine Precursor

Amantadine + L-DOPA for Disorders of Consciousness

Phase < 1
Waitlist Available
Led By Esteban A Fridman, MD, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 2
Awards & highlights

Study Summary

This trial will help researchers understand if a dopaminergic deficiency is linked to a final regulation of excitatory interneurons in people with post-traumatic DOC, by measuring metabotropic glutamate receptors 5 occupancy in key brain structures.

Eligible Conditions
  • Disorders of Consciousness
  • Traumatic Brain Injury

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Delta % changes in binding potential nondisplaceable (%ΔBPnd)
Secondary outcome measures
Coma Recovery Scale Revised

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NMDA blocker + L-DOPAExperimental Treatment1 Intervention
All the patients with DOC that participate in ARM 1 will follow the same methodology of ARM 1: measurement of mGluR5 occupancy at rest and following NMDA-R blockade with AMT by means of [18F]FPEB-PET after premedication with L-DOPA introduced 1 hour prior each [18F]FPEB-PET acquisitions.
Group II: NMDA blockerActive Control1 Intervention
Comprehensive functional analyses of dynamic [18F]FPEB-PET signal at rest will be carried out in normal volunteers and patients with DOC due to severe brain injury over a 24-month time period. In each study, we will first evaluate mGluR5 occupancy within the frontal cortex, anterior cingulate cortex, insula, striatum and thalamus. Then, a single dose of amantadine (AMT), a compound that blocks NMDA-R and increases glutamate levels at the synaptic cleft, will be given to each subject or patient and at the time corresponding to the peak of the dose, a second [18F]FPEB-PET will be acquired.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,498 Total Patients Enrolled
1 Trials studying Disorders of Consciousness
1 Patients Enrolled for Disorders of Consciousness
Esteban A Fridman, MD, PhDPrincipal InvestigatorWeill Medical College of Cornell University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
BrainJournal
Presynaptic Dopamine Deficit in Minimally Conscious State Patients Following Traumatic Brain Injury
Fridman, Esteban A, Joseph R Osborne, Paul D Mozley, Jonathan D Victor, and Nicholas D Schiff. 2019. “Presynaptic Dopamine Deficit in Minimally Conscious State Patients Following Traumatic Brain Injury”. Brain. Oxford University Press (OUP). doi:10.1093/brain/awz118.
Current Opinion in NeurobiologyJournal
Neuromodulation of the Conscious State Following Severe Brain Injuries
Fridman, Esteban A, and Nicholas D Schiff. 2014. “Neuromodulation of the Conscious State Following Severe Brain Injuries”. Current Opinion in Neurobiology. Elsevier BV. doi:10.1016/j.conb.2014.09.008.
Proceedings of the National Academy of SciencesJournal
Regional Cerebral Metabolic Patterns Demonstrate the Role of Anterior Forebrain Mesocircuit Dysfunction in the Severely Injured Brain
Fridman, Esteban A., Bradley J. Beattie, Allegra Broft, Steven Laureys, and Nicholas D. Schiff. 2014. “Regional Cerebral Metabolic Patterns Demonstrate the Role of Anterior Forebrain Mesocircuit Dysfunction in the Severely Injured Brain”. Proceedings of the National Academy of Sciences. Proceedings of the National Academy of Sciences. doi:10.1073/pnas.1320969111.
clinicaltrials.govStudy
Changes in Glutamatergic Neurotransmission of Severe TBI Patients
2020. "Changes in Glutamatergic Neurotransmission of Severe TBI Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04244058.
~7 spots leftby Apr 2025
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