Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Studie av nya magnetresonanstomografimetoder för hjärnan

Karakterisering av hjärnmorfologi och aktivitet med hjälp av funktionell och anatomisk MRI-kontrast

The purpose of this investigation is to develop improved magnetic resonance imaging (MRI) techniques and hardware for studying brain function. MRI is a diagnostic tool that provides information about brain chemistry and physiology. This study will evaluate new MRI methods for monitoring blood flow to regions of the brain in response to simple tasks. The MRI machine used in this study is more powerful than those in most hospitals, permitting a higher visual resolution.

Normal healthy volunteers over 18 years old may be eligible for this study. Candidates will be screened with a medical history and questionnaire, and a neurological examination. Study participants will have a yearly MRI scan. For this procedure, the subject lies on a stretcher that is moved into a donut-shaped machine with a strong magnetic field. A lightweight circular or rectangular coil-a device that improves the quality of the images-may be placed on the head. The scan time varies from 20 minutes to 3 hours; most scans last between 45 and 90 minutes. During the scan, the subject may perform simple tasks, such as listening to tapes, tapping a finger, moving a hand, watching a screen, or smelling a fragrance. More complex tasks may require thinking about tones or pictures and responding to them by pressing buttons.

Information from this study will be used to develop better imaging methods that will, in turn, permit a greater understanding of normal and abnormal brain behaviors.

...

Studieöversikt

Detaljerad beskrivning

Objective

The goal of this protocol is to improve spatial resolution and contrast in MRI studies of brain anatomy and function, by developing novel hardware, and image acquisition and reconstruction techniques. Specifically, by improving MRI image quality and manipulating MRI contrast, we aim to better characterize and quantify structural, chemical, and blood flow variations across the brain, and study their relationship with neuronal activity. For this purpose, we will develop and optimize novel MRI techniques on normal, healthy volunteers, and combine these with EEG and recording of other physiological signals.

Study Population

Any healthy, male or female volunteer 18 years of age and older; the subjects must be capable of understanding the procedures and requirements of this study and be willing to sign an informed consent document.

Design

This is a technical development study design to develop and evaluate new MR technology for performing MRI and functional MRI in the CNS with novel contrasts and with a high spatial resolution.

Outcome Measures

The primary outcome of this study will be the ability to acquire anatomical and functional images of the human brain with high spatial resolution, i.e., 200-500 micron and 750-1000 micron respectively. In addition, developed techniques will allow the robust measurement of specific tissue properties, including diffusion, structural anisotropy, iron and myelin content, perfusion, and metabolite concentrations. The relative merits of blood flow and blood oxygenation level dependent (BOLD) functional MRI (fMRI) techniques, and their particular spatial and temporal signal characteristics will be established. It will be determined whether information valuable to interpret BOLD fMRI can be derived from EEG and other physiological signals.

Studietyp

Observationell

Inskrivning (Beräknad)

1100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

    • Maryland
      • Bethesda, Maryland, Förenta staterna, 20892
        • Rekrytering
        • National Institutes of Health Clinical Center
        • Kontakt:
          • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
          • Telefonnummer: TTY dial 711 800-411-1222
          • E-post: ccopr@nih.gov

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 120 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Healthy Volunteer

Beskrivning

  • INCLUSION CRITERIA:
  • 18 years of age and older
  • in good general health
  • able to understand the procedures and requirements and give informed consent

EXCLUSION CRITERIA:

All Subjects will undergo a neurological physical and answer the Healthy volunteer form, and the most-recent version of the NMR safety screening form

A subject will be excluded if he/she:

  1. has any metal implant or objects of unknown identity or composition, or if it s known to be non-compatible with MRI, such as pacemakers, medication pumps, aneurysm clips, metallic prosthesis (such as heart valves or cochlear implants), certain orthopedic implants (pins and rods), shrapnel, or small metal fragments in the eye;
  2. has claustrophobia;
  3. cannot lie comfortably for up to 120 minutes;
  4. underwent brain surgery or suffered a traumatic head trauma;
  5. has migraines that require medication;
  6. has ever been hospitalized for a psychiatric disorder;
  7. has medical health problems such as pulmonary or airway disease, heart failure, coronary artery disease, and uncontrolled hypertension which would require physiological monitoring during the scan;
  8. has a history of any medical condition that could result in an emergency medical situation while undergoing the MRI scan;
  9. has hearing problems which would make it difficult to tolerate scanner noise;
  10. is pregnant;
  11. has body/make-up tattoos (e.g. lips, eyebrows, eyeliner). Each tattoo will be considered on a case-to-case basis, taking into account of the age and location of the tattoo;
  12. has a sleep apnea diagnosis;
  13. has a neurological disorder, such as Stroke, Parkinson s, and Epilepsy;
  14. a member of the NINDS Laboratory of Functional and Molecular Imaging.

The contraindications to MRI at the various field strengths are almost identical, except the 7 T also excludes subjects with gold dental crowns.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: COHORT
  • Tidsperspektiv: PROSPECTIVE

Kohorter och interventioner

Grupp / Kohort
Healthy Volunteer

Any healthy, male or female volunteer 18 years of age and older.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
The purpose of this study is to develop and evaluate new MR pulse sequences and hardware for performing anatomical and functional MRI in the CNS at, 3.0T, and 7T with a high spatial resolution.
Tidsram: annually

The primary outcome of this study will be the ability to robustly acquire whole brain MRI sensitized to myelin, iron, diffusion, perfusion, and fiber orientation. Perfusion- and BOLD- based fMRI techniques will allow distinguishing between neuronal and systemic vascular signal contributions. In addition, we anticipate the ability to acquire (proton) spectroscopic data at 5mm resolution.

annually

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To develop an understanding of the limits in contrast and resolution of anatomical and functional MRI.To develop an understanding of the merits of high field MRI for the study of brain anatomy and function.
Tidsram: annually

Secondary outcome measure will be an estimate of the relative performance levels of the different field strengths for anatomical, functional and spectroscopic imaging.

annually

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Alan P Koretsky, Ph.D., National Institute of Neurological Disorders and Stroke (NINDS)

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2000

Studieregistreringsdatum

Först inskickad

18 februari 2000

Först inskickad som uppfyllde QC-kriterierna

18 februari 2000

Första postat (Beräknad)

21 februari 2000

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 oktober 2026

Senast verifierad

25 augusti 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera