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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

Must not have

Patients with Obstructive Sleep Apnea

Coagulopathy, anticoagulant medications that cannot be discontinued safely for perioperative period, uncontrolled hypertension, history of seizures, heart disease, inability to undergo general anesthesia, or other medical conditions considered to place the patient at elevated risk for surgical complications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up years 1-3

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My movement symptoms are severe and need surgery despite medication.

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My brain MRI does not show any issues that would prevent surgery.

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I am between 18 and 80 years old, or at least 19 if I live in Nebraska.

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I have been approved for DBS surgery by a specialized team.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Obstructive Sleep Apnea.

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I do not have any health conditions that would make surgery too risky.

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I have had brain surgery before.

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I have Restless Leg Syndrome.

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I cannot perform the recharge process for the RC+S system.

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I am currently receiving ECT, rTMS, or diathermy treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ years 1-3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~years 1-3

This trial's timeline: 3 weeks for screening, Varies for treatment, and years 1-3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Sleep efficiency

Subjective Sleep Quality

Secondary study objectives

Duration of REM sleep stage

Side effects data

From 2018 Phase 2 trial • 53 Patients • NCT01221948

23%

Fall

15%

Depression

Hand fracture

Restless legs syndrome

Apathy

Dyspepsia

Back pain

Skeletal injury

Head injury

Speech disorder

Tremor

Gait disturbance

Dystonia

Paraesthesia

Influenza

Urinary tract infection

Osteoarthritis

Ingrowing nail

Postoperative wound infection

Diabetes mellitus

Pain in extremity

Spinal osteoarthritis

Alcohol poisoning

Intervertebral disc protrusion

Hypoaesthesia

Diplopia

Contusion

Productive cough

Joint sprain

Macular degeneration

Fluid retention

Device migration

Skin laceration

Akinesia

Parkinson's disease

Syncope

Respiratory depression

Rib fracture

Drug withdrawal syndrome

Cerebral microangiopathy

Dysarthria

Memory impairment

Movement disorder

Monarthritis

Neck pain

Adverse drug reaction

Cyst

Implant site haematoma

Oedema peripheral

Pyrexia

Pleural effusion

Nerve root lesion

Anxiety

Cough

Fibula fracture

Thermal burn

Sciatica

Anger

Bursitis

Cystitis

Helicobacter gastritis

Implant site infection

Localised infection

Pneumonia

Staphylococcal infection

Confusional state

Depressed mood

Hallucination, auditory

Impulse-control disorder

Insomnia

Panic attack

Rapid eye movements sleep abnormal

Bronchitis

Ear infection

Incision site infection

Arthralgia

Axillary pain

Folate deficiency

Hypertension

Hypotension

Thrombophlebitis

Laboratory test abnormal

Weight increased

Pericardial effusion

Seborrhoeic keratosis

Urinary incontinence

100%

80%

60%

40%

20%

Study treatment Arm

Deep Brain Stimulation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~710

0 / 10Eligibility criteria met