Motornettverksfysiologi
Karakterisering av motornettverksfysiologi under dyp hjernestimuleringskirurgi
The brain networks controlling movement are complex, involving multiple areas of the brain. Some neurological disorders, like Parkinson's disease (PD) and essential tremor (ET), cause abnormalities in these brain networks. Deep brain stimulation is a treatment that is used to treat these types of neurological diseases and is thought to help patients by modulating brain networks responsible for movement. Levodopa medication is also used to modulate this brain networks in patients with PD. The overall objective is to develop a unified theory of basal ganglia thalamocortical (BGTC) circuit dynamics that accounts for disease symptomatology, movement, and their inter-relationship. The underlying hypothesis, is that the rigidity and bradykinesia of PD are fundamentally related to excessive functional coupling across nodes in the BGTC motor circuit impeding effective information flow. In this research, the investigator will take advantage of the unique opportunity provided by awake deep brain stimulation surgery to learn more about how the brain functions in a diseased state and how deep brain stimulation changes these networks to make movement more normal. The investigator will simultaneously assess cortical and subcortical electrophysiology in relation to clinical symptoms and behavioral measures and in response to deep brain stimulation, cortical stimulation, and pharmacologic therapy in patients undergoing Deep Brain Stimulation (DBS) implantation surgery.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Nader Pouratian, MD, PhD
- Telefonnummer: (214)645-5465
- E-post: nader.pouratian@utsouthwestern.edu
Studer Kontakt Backup
- Navn: Sachil Chilukuri
- Telefonnummer: 2146455465
- E-post: sahil.chilukuri@utsouthwestern.edu
Studiesteder
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-
Texas
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Dallas, Texas, Forente stater, 75390
- Rekruttering
- UT Southwestern Medical Center
-
Ta kontakt med:
- Nader Pouratian
- E-post: nader.pouratian@utsouthwestern.edu
-
Ta kontakt med:
- Sahil Chilukuri
- E-post: sahil.chilukuri@utsouthwestern.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Diagnosis of Parkinson's disease who have been recommended to undergo deep brain stimulation for management of their movement disorder
- Preoperative MRI without evidence of cortical or subdural adhesions or vascular abnormalities
- Willingness and ability to cooperate during conscious operative procedure for up to 40 minutes
Exclusion Criteria:
- Patients with recent use (within one week) of anticoagulant or antiplatelet agents
- Neurocognitive testing indicating amnestic cognitive deficits
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Parkinson's disease patients
This group consists of Parkinson's disease patients who are undergoing deep brain stimulation surgery for treatment of their movement disorder. Participants will complete behavioral assessments while receiving subcortical DBS stimulation and / or inhaled levodopa medication, Inbrija. Stimulation will be applied at the previously determined therapeutic frequency. Two capsules (84 mg) of Inbrija will be administered. |
Apomorphine injected for therapeutic relief Subcortical simulation of the deep brain stimulation surgery target site will be applied by clinically placed deep brain stimulation electrodes at the previously determined therapeutic setting |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
cortical ECoG and subcortical recordings
Tidsramme: baseline
|
Cortical ECoG and subcortical LFP recordings will occur during DBS implantation surgery during the behavioral assessments and/or Inbrija administration. |
baseline
|
|
Behavioral assessment
Tidsramme: baseline
|
Each patient will complete a task that assesses the kinematics of movement, self-initiation of movement, and/or effect of Inbrija on movement |
baseline
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Nader Pouratian, MD, PhD, University of Texas Southwestern Medical Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STU-2021-0376
- 1R01NS097782-01A1 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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