Építés alatt – nem éles oldal
Belépés

NCT03582891Fut, nem toboroz

The Motor Network in Parkinson's Disease and Dystonia: Mechanisms of Therapy

Closed Loop Deep Brain Stimulation in Parkinson's Disease and Dystonia (Activa RC+S)

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. jún. 11.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

This is an exploratory pilot study to identify neural correlates of specific motor signs in Parkinson's disease (PD) and dystonia, using a novel totally implanted neural interface that senses brain activity as well as delivering therapeutic stimulation. Parkinson's disease and isolated dystonia patients will be implanted unilaterally or bilaterally with a totally internalized bidirectional neural interface, Medtronic Summit RC+S. This study includes three populations: ten PD patients undergoing deep brain stimulation in the subthalamic nucleus (STN), ten PD patients with a globus pallidus (GPi) target and five dystonia patients. All groups will test a variety of strategies for feedback-controlled deep brain stimulation, and all patients will undergo a blinded, small pilot clinical trial of closed-loop stimulation for thirty days.

Állapot (regiszter)
Fut, nem toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
25 (tervezett)
Első benyújtás
2018. jún. 14.
Kezdés
2018. okt. 1.
Elsődleges befejezés
2025. dec. 31.
Fő szponzor
University of California, San Francisco
Betegségek
Parkinson-kór
NCT-szám
NCT03582891

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 25
  • 2018. okt. 1. és az elsődleges befejezés (2025. dec. 31.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.

Ki nem vehet részt

Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.

Korábbi kezelés

  • Pregnancy: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
  • Implanted stimulation systems such as; cochlear implant, pacemaker, defibrillator, neurostimulator or metallic implant
  • Previous cranial surgery
  • Drug or alcohol abuse
  • Pregnancy: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure.
  • Implanted stimulation systems such as; cochlear implant, pacemaker, defibrillator, neurostimulator or metallic implant
  • Previous cranial surgery
  • Drug or alcohol abuse

Más betegség

  • Parkinson's Disease:
  • Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of seizures, heart disease, or other medical conditions considered to place the patient at elevated risk for surgical complications
  • Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion or "while unobserved", symptoms that are inconsistent over time or incongruent with clinical condition, plus other manifestation such as "false" signs, multiple somatizations, or obvious psychiatric disturbance.
  • Significant untreated depression (BDI-II score >20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS)
  • Meets criteria for Parkinson's disease with mild cognitive impairment (PD-MCI). These criteria are: performance of more than two standard deviations below appropriate norms, for tests from two or more of these five cognitive domains: attention, executive function, language, memory, and visuospatial tests.
    • Dystonia:
  • Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of seizures, heart disease, or other medical conditions considered to place the patient at elevated risk for surgical complications
  • Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion or "while unobserved", symptoms that are inconsistent over time or incongruent with clinical condition, plus other manifestation such as "false" signs, multiple somatizations, or obvious psychiatric disturbance.
  • Significant untreated depression (BDI-II score >20) History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS)

Egyéb

  • Any personality or mood symptoms that study personnel believe will interfere with study requirements.
  • Subjects who require ECT, rTMS or diathermy
  • Any personality or mood symptoms that study personnel believe will interfere with study requirements.
  • Subjects who require ECT, rTMS or diathermy

Kiket keres a vizsgálat

  • Parkinson's Disease:
  • Ability to give informed consent for the study
  • Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
  • Patient has requested surgical intervention with deep brain stimulation for their disorder
  • No MR abnormalities that suggest an alternative diagnosis or contraindicate surgery
  • Absence of significant cognitive impairment (score of 20 or greater on the Montreal Cognitive Assessment (MoCA),
  • Signed informed consent
  • Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment.
  • Age 21-75 (for STN patients, minimum age is 25)
  • Diagnosis of idiopathic PD with duration of motor symptoms for 4 years or greater
  • Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist, and has had stable doses of antiparkinsonian medications for 30 days prior to baseline assessment.
  • UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score, and motor fluctuations with at least 2 hours per day of on time without dyskinesia or with non-bothersome dyskinesia.
    • OR Patients with tremor-dominant PD (a tremor score of at least 2 on a UPDRS-III sub-score for tremor), treatment resistant, with significant functional disability despite maximal medical management
    • Dystonia:
  • Ability to give informed consent for the study
  • Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria
  • Patient has requested surgical intervention with deep brain stimulation for their disorder
  • No MR abnormalities that suggest an alternative diagnosis or contraindicate surgery
  • Absence of significant cognitive impairment (score of 20 or greater on the Montreal Cognitive Assessment (MoCA)
  • Signed informed consent
  • Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment.
  • Age 21-75
  • Diagnosis of Isolated dystonia, which may be focal cervical, segmental craniocervical, or generalized forms.
  • Stable doses of anti-dystonia medications (such as trihexyphenydil, Baclofen, or clonazepam) for at least 30 days prior to baseline assessment
  • For dystonia patients with craniofacial and cervical involvement, prior treatment with botulinum toxin with failure to adequately control dystonia symptoms.

Életkor a regiszterben: 21 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
University of California at San FranciscoSan FranciscoEgyesült ÁllamokIsmeretlen állapot

Te vagy a koordinátor? Erősítsd meg az adatokat

Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.