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Neurostimulation
Neurostimulation for Sleep Problems in Parkinson's Disease
N/A
Recruiting
Led By Aviva Abosch, MD, PhD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Motor symptoms (e.g., motor fluctuations, dyskinesia, tremor, bradykinesia, rigidity) that are severe enough, despite optimized medical therapy, to warrant surgical implantation of DBS, according to standard clinical criteria
Absence of abnormalities on brain MRI suggestive of an alternate diagnosis or serving as a contraindication to surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up years 1-3
Awards & highlights
Study Summary
This trial is testing whether an adaptive stimulation protocol can improve sleep quality for adults with Parkinson's disease.
Who is the study for?
Adults aged 18-80 with Parkinson's disease and motor symptoms for at least 4 years, who are approved for Subthalamic Nucleus (STN) Deep Brain Stimulation surgery. Participants must not have significant cognitive deficits or untreated depression, no history of drug/alcohol abuse, and cannot be pregnant.Check my eligibility
What is being tested?
The trial is testing an adaptive stimulation protocol using the Medtronic RC+S System during sleep to improve sleep quality in Parkinson's patients. It compares three nocturnal stimulations: Adaptive, Open-Loop (standard therapy), and No stimulation over a period of three weeks.See study design
What are the potential side effects?
Potential side effects may include discomfort from wearing the actigraphy watch, possible skin irritation or infection at the surgical site, headache, nausea related to surgery or device implantation, and any typical risks associated with general anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My movement symptoms are severe and need surgery despite medication.
Select...
My brain MRI does not show any issues that would prevent surgery.
Select...
I am between 18 and 80 years old, or at least 19 if I live in Nebraska.
Select...
I have been approved for DBS surgery by a specialized team.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ years 1-3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~years 1-3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sleep efficiency
Subjective Sleep Quality
Secondary outcome measures
Duration of REM sleep stage
Side effects data
From 2018 Phase 2 trial • 53 Patients • NCT0122194823%
Fall
15%
Depression
8%
Hand fracture
8%
Restless legs syndrome
8%
Apathy
5%
Head injury
5%
Dyspepsia
5%
Back pain
5%
Speech disorder
5%
Skeletal injury
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
3%
Pain in extremity
3%
Diabetes mellitus
3%
Intervertebral disc protrusion
3%
Spinal osteoarthritis
3%
Fluid retention
3%
Postoperative wound infection
3%
Osteoarthritis
3%
Macular degeneration
3%
Hypoaesthesia
3%
Ingrowing nail
3%
Respiratory depression
3%
Parkinson's disease
3%
Akinesia
3%
Productive cough
3%
Device migration
3%
Syncope
3%
Diplopia
3%
Skin laceration
3%
Joint sprain
3%
Rib fracture
3%
Drug withdrawal syndrome
3%
Alcohol poisoning
3%
Contusion
3%
Cerebral microangiopathy
3%
Dysarthria
3%
Memory impairment
3%
Movement disorder
3%
Monarthritis
3%
Neck pain
3%
Adverse drug reaction
3%
Cyst
3%
Implant site haematoma
3%
Oedema peripheral
3%
Pyrexia
3%
Pleural effusion
3%
Nerve root lesion
3%
Anxiety
3%
Cough
3%
Fibula fracture
3%
Thermal burn
3%
Sciatica
3%
Anger
3%
Bursitis
3%
Cystitis
3%
Helicobacter gastritis
3%
Implant site infection
3%
Localised infection
3%
Pneumonia
3%
Staphylococcal infection
3%
Confusional state
3%
Depressed mood
3%
Hallucination, auditory
3%
Impulse-control disorder
3%
Insomnia
3%
Panic attack
3%
Rapid eye movements sleep abnormal
3%
Bronchitis
3%
Ear infection
3%
Incision site infection
3%
Arthralgia
3%
Axillary pain
3%
Folate deficiency
3%
Hypertension
3%
Hypotension
3%
Thrombophlebitis
3%
Laboratory test abnormal
3%
Weight increased
3%
Pericardial effusion
3%
Seborrhoeic keratosis
3%
Urinary incontinence
100%
80%
60%
40%
20%
0%
Study treatment Arm
Deep Brain Stimulation
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Adaptive DBS stimulationExperimental Treatment1 Intervention
Subjects experience adaptive stimulation during one week of at-home night sleep.
Group II: Open-loop DBS stimulationActive Control1 Intervention
Subjects experience open-loop stimulation (standard clinical stimulation therapy based on DBS programming for the treatment of motor symptoms) during one week of at-home night sleep.
Group III: No DBS StimulationActive Control1 Intervention
DBS stimulation is turned off (control) during one week of at-home night sleep.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~700
Find a Location
Who is running the clinical trial?
University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,714 Total Patients Enrolled
Aviva Abosch, MD, PhDPrincipal InvestigatorUniversity of Nebraska
3 Previous Clinical Trials
91 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with Parkinson's disease and have had motor symptoms for at least 4 years.My movement symptoms are severe and need surgery despite medication.I have been diagnosed with Obstructive Sleep Apnea.I have Parkinson's with mild cognitive issues in at least two areas like memory or attention.My brain MRI does not show any issues that would prevent surgery.I am between 18 and 80 years old, or at least 19 if I live in Nebraska.You don't have major memory or thinking problems, or severe feelings of sadness.My Parkinson's symptoms improve by at least 30% with medication, or I have significant, treatment-resistant tremor.I do not have any health conditions that would make surgery too risky.You have a history of using drugs or alcohol in a harmful way.I have been approved for DBS surgery by a specialized team.I have had brain surgery before.I have Restless Leg Syndrome.My Parkinson's symptoms haven't improved enough with oral medications, as confirmed by a specialist.I can attend all my follow-up neurological care at the study site for 9 years.I cannot perform the recharge process for the RC+S system.You have a medical device like a pacemaker or cochlear implant, or a metal implant that could be affected by the study.I am currently receiving ECT, rTMS, or diathermy treatments.You have severe untreated depression, based on specific scoring tests.
Research Study Groups:
This trial has the following groups:- Group 1: Open-loop DBS stimulation
- Group 2: No DBS Stimulation
- Group 3: Adaptive DBS stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical research allow participants over the age of eighty?
"This research study is seeking applicants between 19 and 80 years old. For patients younger than 18, 31 studies are available, while 497 exist for individuals over 65."
Answered by AI
How many participants are currently being accepted into this experiment?
"Affirmative. According to clinicaltrials.gov, the study that was first posted on November 18th 2021 is currently recruiting patients. An estimated 20 participants are needed across 2 sites of enrollment."
Answered by AI
Is this medical investigation currently admitting new participants?
"Per clinicaltrials.gov, this clinical trial is open for recruitment and was initially advertised on November 18th 2021 with a follow-up update issued on February 2nd 2022."
Answered by AI
Is it feasible for me to partake in this investigation?
"This research is seeking 20 individuals aged between 19 and 80 that suffer from sleep fragmentation. Additionally, the following criteria must be met: UPDRS-III score off medication between 20 and 80, an improvement in UPDRS-III score on medications of at least 30%, tremor-dominant PD (score >/= 2 on UPDRS-III tremor sub-score) or treatment resistant motor symptoms leading to functional disability., Severe motor symptoms despite optimized medical therapy necessitating surgical implantation of DBS according to standard clinical criterion, Patient requested DBS surgery with approval from Multi Disciplinary Movement Disorders Patient Care Conference for"
Answered by AI
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