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Unable to enroll subjects due to COVID and complexity of study.
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The aim of this study is to investigate whether researchers can improve sleep quality in patients with deep brain stimulators by delivering targeted stimulation patterns during specific stages of sleep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deep Brain Stimulation (DBS) system | Experimental | Subjects with existing DBS systems implanted for neurological disease (e.g., Parkinson's, pain, epilepsy) will have targeted stimulation patterns during specific stages of sleep using their existing DBS device. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBS Stimulation during sleep | Device | Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants to Complete Study | Total number of participants to complete all scheduled study activities | Through study completion, approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time | Length of sleep time reported in minutes | Baseline, post-intervention (approximately 1 night) |
| Psychomotor Vigilance Test | Measures reaction time (milliseconds) by asking subjects to press a button on an electronic device as soon as a light appears (every few seconds for 10 minutes). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Worrell, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Deep Brain Stimulation (DBS) System | Subjects with existing DBS systems implanted for neurological disease (e.g., Parkinson's, pain, epilepsy) will have targeted stimulation patterns during specific stages of sleep using their existing DBS device. DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Deep Brain Stimulation (DBS) System | Subjects with existing DBS systems implanted for neurological disease (e.g., Parkinson's, pain, epilepsy) will have targeted stimulation patterns during specific stages of sleep using their existing DBS device. DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participants to Complete Study | Total number of participants to complete all scheduled study activities | Posted | Count of Participants | Participants | Through study completion, approximately 1 year |
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Adverse events were collected from baseline to end of study participation for a total of approximately 4 days on all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Deep Brain Stimulation (DBS) System | Subjects with existing DBS systems implanted for neurological disease (e.g., Parkinson's, pain, epilepsy) will have targeted stimulation patterns during specific stages of sleep using their existing DBS device. DBS Stimulation during sleep: Open and closed-loop electrical modulation triggered and based on ongoing sleep staging by researcher as well as automated closed-loop algorithm for stimulation. |
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This study was terminated due to inability to enroll subjects due to COVID and complexity of study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory A. Worrell | Mayo Clinic | 507-538-4880 | Worrell.Gregory@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2021 | Sep 27, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 13, 2023 | Sep 27, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D010300 | Parkinson Disease |
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Baseline, post-intervention (approximately 1 night) |
| Karolinska Sleepiness Scale | Measures subjective level of tiredness at a particular time during the day using a 9-point scoring scale of 1 = extremely alert, 3 = alert, 5 = neither alert nor sleepy, 7 = sleepy - but no difficulty remaining awake, and 9 = extremely sleepy - fighting sleep. | Baseline, post-intervention (approximately 1 night) |
| Latency to Sleep Onset | Time in minutes from beginning of study to the first stage of sleep | Baseline, post-intervention (approximately 1 night) |
| Latency to Rapid Eye Movement (REM) Sleep | Time in minutes from beginning of sleep to first REM sleep onset. | Baseline, post-intervention (approximately 1 night) |
| Number of Sleep Cycles | Total number of sleep cycles defined as switches of non-rapid eye movement (NREM) and rapid eye movement (REM) sleep. | Baseline, post-intervention (approximately 1 night) |
| Number of Awakenings Per Night | Total number of awakenings during night | Baseline, post-intervention (approximately 1 night) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Participants |
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| Secondary | Total Sleep Time | Length of sleep time reported in minutes | Posted | Mean | Standard Deviation | minutes | Baseline, post-intervention (approximately 1 night) |
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| Secondary | Psychomotor Vigilance Test | Measures reaction time (milliseconds) by asking subjects to press a button on an electronic device as soon as a light appears (every few seconds for 10 minutes). | Posted | Mean | Standard Deviation | milliseconds | Baseline, post-intervention (approximately 1 night) |
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|
| Secondary | Karolinska Sleepiness Scale | Measures subjective level of tiredness at a particular time during the day using a 9-point scoring scale of 1 = extremely alert, 3 = alert, 5 = neither alert nor sleepy, 7 = sleepy - but no difficulty remaining awake, and 9 = extremely sleepy - fighting sleep. | Posted | Mean | Standard Deviation | score on a scale | Baseline, post-intervention (approximately 1 night) |
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| Secondary | Latency to Sleep Onset | Time in minutes from beginning of study to the first stage of sleep | Posted | Mean | Standard Deviation | minutes | Baseline, post-intervention (approximately 1 night) |
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| Secondary | Latency to Rapid Eye Movement (REM) Sleep | Time in minutes from beginning of sleep to first REM sleep onset. | Posted | Mean | Standard Deviation | minutes | Baseline, post-intervention (approximately 1 night) |
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| Secondary | Number of Sleep Cycles | Total number of sleep cycles defined as switches of non-rapid eye movement (NREM) and rapid eye movement (REM) sleep. | Posted | Mean | Standard Deviation | number of sleep cycles | Baseline, post-intervention (approximately 1 night) |
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| Secondary | Number of Awakenings Per Night | Total number of awakenings during night | Posted | Mean | Standard Deviation | number of awakenings | Baseline, post-intervention (approximately 1 night) |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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