Deep Brain Stimulation for Parkinson's Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Parkinson's Disease+1 MoreDeep Brain Stimulation - Device
Eligibility
19 - 80
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether an adaptive stimulation protocol can improve sleep quality for adults with Parkinson's disease.

Eligible Conditions
  • Parkinson's Disease
  • Sleep Fragmentation

Treatment Effectiveness

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Years 1-3

Years 1-3
Duration of REM sleep stage
Sleep efficiency
Subjective Sleep Quality

Trial Safety

Side Effects for

Deep Brain Stimulation
23%Fall
15%Depression
8%Restless legs syndrome
8%Apathy
8%Hand fracture
5%Urinary tract infection
5%Speech disorder
5%Influenza
5%Head injury
5%Dystonia
5%Tremor
5%Gait disturbance
5%Skeletal injury
5%Paraesthesia
5%Back pain
5%Dyspepsia
3%Rapid eye movements sleep abnormal
3%Ingrowing nail
3%Hallucination, auditory
3%Impulse-control disorder
3%Insomnia
3%Panic attack
3%Confusional state
3%Depressed mood
3%Implant site infection
3%Localised infection
3%Staphylococcal infection
3%Device migration
3%Joint sprain
3%Skin laceration
3%Parkinson's disease
3%Syncope
3%Fibula fracture
3%Rib fracture
3%Memory impairment
3%Movement disorder
3%Nerve root lesion
3%Sciatica
3%Bronchitis
3%Ear infection
3%Incision site infection
3%Bursitis
3%Intervertebral disc protrusion
3%Neck pain
3%Pain in extremity
3%Spinal osteoarthritis
3%Adverse drug reaction
3%Axillary pain
3%Drug withdrawal syndrome
3%Implant site haematoma
3%Oedema peripheral
3%Productive cough
3%Diabetes mellitus
3%Fluid retention
3%Folate deficiency
3%Macular degeneration
3%Laboratory test abnormal
3%Pericardial effusion
3%Seborrhoeic keratosis
3%Urinary incontinence
3%Respiratory depression
3%Anxiety
3%Cyst
3%Hypertension
3%Hypotension
3%Pneumonia
3%Cystitis
3%Akinesia
3%Helicobacter gastritis
3%Alcohol poisoning
3%Thermal burn
3%Cerebral microangiopathy
3%Hypoaesthesia
3%Contusion
3%Dysarthria
3%Anger
3%Postoperative wound infection
3%Arthralgia
3%Cough
3%Pleural effusion
3%Monarthritis
3%Osteoarthritis
3%Diplopia
3%Pyrexia
3%Weight increased
3%Thrombophlebitis
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01221948) in the Deep Brain Stimulation ARM group. Side effects include: Fall with 23%, Depression with 15%, Restless legs syndrome with 8%, Apathy with 8%, Hand fracture with 8%.

Trial Design

3 Treatment Groups

No DBS Stimulation
1 of 3
Open-loop DBS stimulation
1 of 3
Adaptive DBS stimulation
1 of 3

Active Control

Experimental Treatment

20 Total Participants · 3 Treatment Groups

Primary Treatment: Deep Brain Stimulation · No Placebo Group · N/A

Adaptive DBS stimulation
Device
Experimental Group · 1 Intervention: Deep Brain Stimulation · Intervention Types: Device
No DBS StimulationNoIntervention Group · 1 Intervention: No DBS Stimulation · Intervention Types:
Open-loop DBS stimulation
Device
ActiveComparator Group · 1 Intervention: Deep Brain Stimulation · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~700

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: years 1-3

Who is running the clinical trial?

University of NebraskaLead Sponsor
487 Previous Clinical Trials
1,149,330 Total Patients Enrolled
Aviva Abosch, MD, PhDPrincipal InvestigatorUniversity of Nebraska
3 Previous Clinical Trials
91 Total Patients Enrolled

Eligibility Criteria

Age 19 - 80 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have motor symptoms that have been present for at least 4 years.
Patient has requested DBS surgery, and has been approved by the site (UNMC or University of Pennsylvania) Multi-Disciplinary Movement Disorders Patient Care Conference for STN DBS.
You are a female and are between the ages of 18 and 80 years.
Absence of abnormalities on brain MRI suggestive of an alternate diagnosis or serving as a contraindication to surgery.
You have no significant cognitive deficits or significant depression (BDI-II score > 20) on formal Neuropsychological Testing.