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Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study

10. december 2015 opdateret af: Hamilton Health Sciences Corporation

Mechanism of Amantadine and Functional Improvement Following Acquired Brain Injury as Measured by MRI Tractography; A Pilot Study

This is a pilot study. The objective is to further understand the mechanism by which amantadine improves function in patients with persistent vegetative state and minimally conscious state. Specifically, the investigators will measure the size of the nerve fibers that mediate arousal (reticular activating system, or RAS) pre and post treatment on MRI tractography. MRI findings will be correlated with the Disability Rating Scale (DRS) score. The information gathered from this study will be used to formulate a larger clinical trial.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Primary Aim:

To determine the size of the RAS tracts as measured by MRI tractography. Specifically, the investigators will be measuring the fiber tracts that project through the posterior thalamus. The RAS is involved in mediating arousal and consciousness. The size of fiber tracts will be measured prior to initiating treatment and near the time of discharge from the rehabilitation hospital or at approximately ninety-days. It is hypothesized that treatment will result in an increase in the size of these fiber tracts.

As a pilot study, the investigators will be determining the feasibility of recruiting and retaining patients in this type of study. This will allow the clarification and understanding of the technical standards for MRI tractography related to the assessment of the reticular activating system.

Secondary Aim:

To determine and monitor changes in function following acquired brain injury as measured by the Disability Rating Scale (DRS) score. The DRS score will be obtained prior to initiating treatment and at termination of the study. It is hypothesized that treatment with amantadine in addition to standard medical treatment, will be associated with an improvement in function.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

10

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Hamilton Health Sciences

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18 years - 65 years
  • Nonpenetrating acquired brain injury (ABI)
  • Persistent vegetative or minimally conscious state (as indicated by DRS score greater than 11)
  • Consent from substitute decision maker

Exclusion Criteria:

  • Contraindication to MRI (such as metal in the body, pacemaker, implanted nerve stimulator)
  • Anticipated neurosurgical intervention
  • Medical instability including uncontrolled hypertension, fever, or infection
  • Seizure disorder prior to acquired brain injury or uncontrolled seizures subsequent to acquired brain injury
  • Parkinson's disease
  • History of heart failure or pre-existing peripheral oedema
  • History of eczematoid dermatitis
  • History of angle-closure glaucoma
  • History of neuroleptic malignant syndrome
  • Current treatment with Amantadine
  • Impairment related to other neurologic disease other than ABI
  • Allergy to Amantadine
  • Pregnancy or lactation
  • Impairment of renal function (creatinine clearance less than 60ml/min)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Treatment and MRI scanning
After informed consent has been obtained, the subjects will be examined by a physician and assigned a Disability Ratings Scale (DRS) score. Subjects will undergo MRI tractography study, which does not require the administration of contrast. All participants will receive oral amantadine at escalating doses to ensure tolerance (50mg twice daily for 7 days, then 100mg twice daily for 1 week, then 150mg twice daily, then 200mg twice daily). The usual length of stay on the inpatient brain injury program is ninety days. The MRI tractography study and DRS score will be repeated near the time of discharge or ninety days from enrollment.
Medicin: Amantadine
Participants will initially receive amantadine at the starting dose of 50mg twice daily either by mouth or feeding tube. The dosage will increase every week by 50mg twice daily (100mg total dose increase) up to the target dose of 200mg twice daily. These are the usual doses and rate of increase that are offered to patients with brain injury.
Andre navne:
  • amantadine hydrochloride
Procedure: MRI Tractography Study
Participants will initially receive a baseline MRI Tractography scan. The size of RAS fiber tracts will be measured prior to initiating treatment and near the time of discharge from the rehabilitation hospital or at approximately ninety-days.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Radiographic Changes
Tidsramme: At baseline and ninety days or at time of discharge from hospital if occurs earlier.
MRI Tractography will be performed to measure the size the of reticular activating system fiber tracts. Specifically, the tracts that project through the posterior thalamus.
At baseline and ninety days or at time of discharge from hospital if occurs earlier.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Functional Improvement
Tidsramme: At ninety days or at time of discharge from hospital if occurs earlier.
Disability Rating Scale Score (at enrolment and at completion of the study).
At ninety days or at time of discharge from hospital if occurs earlier.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hamilton Health Sciences Corporation

Efterforskere

  • Ledende efterforsker: Pankaj E Bansal, MD, Hamilton Health Sciences Corporation
  • Ledende efterforsker: Seyed Hosseini, MD, Hamilton Health Sciences Corporation

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2016

Primær færdiggørelse (Forventet)

1. december 2016

Studieafslutning (Forventet)

1. juni 2017

Datoer for studieregistrering

Først indsendt

23. september 2015

Først indsendt, der opfyldte QC-kriterier

30. september 2015

Først opslået (Skøn)

2. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

11. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 0452

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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