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NCT03815656

Closed Loop DBS Implanted RC+S Study

StatusEnrolling by Invitation
PhaseNot applicable
Primary completion
Track this trial

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Record History

All 16 versions: 12 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 21 words Show 6 more changesShow less
    • Primary endpoints: details revised at 4 of 4 entries
    • Primary completion date changed from estimate of Jan 2027 to Oct 22, 2026
    • Study completion pushed from Jan 2027 to Jul 2027
    • Secondary endpoints: details revised at 12 of 12 entries
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 2 words
  2. Trial status: Active, Not Recruiting to Enrolling by Invitationv15 Show 4 more changesShow less
    • Enrollment target: 6 to 46
    • Eligibility criteria expanded, about 47 words
    • Study description expanded, about 87 words
    • Study arms: 1 to 2
  3. Trial status: Suspended to Active, Not Recruiting
    • Primary and study completion dates pushed to Jan 2027
    • Primary endpoints: 2 to 4
    • Secondary endpoints: 3 to 12
    v12
  4. Trial status: Active, Not Recruiting to Suspended Sponsor's reason: additional funding is pending
    • Primary completion date changed from estimate of Nov 2022 to Nov 11, 2022
    • Study completion date: Nov 2022 to Nov 2026
    v11
  5. Primary and study completion dates: Oct 2022 to Nov 2022v10
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Primary and study completion dates: Jul 2022 to Oct 2022
    v7
  2. Trial status: Suspended to Enrolling by Invitationv6
  3. Trial status: Enrolling by Invitation to Suspended Sponsor's reason: temporarily suspended due to COVID-19 social distancing measuresv5
  4. Start date changed from estimate of Jul 2019 to Jul 10, 2019v4
  5. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Primary and study completion dates: Dec 2021 to Jul 2022
    v3
  6. Start date: May 2019 to Jul 2019v2
  1. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 12 months after IPG implant.
Timeframe: baseline and 12 months after IPG implant
Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 24 months after IPG implant.
Timeframe: baseline and 24 months after IPG implant
Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 48 months after IPG implant.
Timeframe: baseline and 48 months after IPG implant
Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 72 months after IPG implant.
Timeframe: baseline and 72 months after IPG implant

Secondary (12)

Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 12 months after IPG implant.
Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 24 months after IPG implant.
Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 48 months after IPG implant.
Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 72 months after IPG implant.
Change in percentage of waking hours with good "on" time at 12 months after IPG implant.
Show 7 moreShow less
Change in percentage of waking hours with good "on" time at 24 months after IPG implant.
Change in percentage of waking hours with good "on" time at 48 months after IPG implant.
Change in percentage of waking hours with good "on" time at 72 months after IPG implant.
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 12 months after IPG implant.
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 24 months after IPG implant.
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 48 months after IPG implant.
Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 72 months after IPG implant.

Arms and interventions

Implanted RC+SExperimental

Implanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.

speech raterNo intervention

blinded raters to score audio recordings of speech

Devices: STN alone, GPi alone, STN + GPi, Closed-loop stimulation

Sites

1 site in 1 country

  • Duke University Medical CenterDurham, North Carolina, United States