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Deep Brain Stimulation
Deep Brain Stimulation for Parkinson's Disease
N/A
Waitlist Available
Led By Drew S Kern, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with Parkinson's Disease
Patients with no current deep brain stimulating electrodes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights
Study Summary
This trial is testing whether electrical stimulation of the rZI, in addition to the STN, can provide relief from Parkinson's disease symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
People with Parkinson's disease are not eligible.
Select...
You do not have any deep brain stimulating electrodes in place.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Motor testing
Secondary outcome measures
Anxiety
Cognition
Depression
+4 moreSide effects data
From 2018 Phase 2 trial • 53 Patients • NCT0122194823%
Fall
15%
Depression
8%
Hand fracture
8%
Restless legs syndrome
8%
Apathy
5%
Back pain
5%
Head injury
5%
Speech disorder
5%
Skeletal injury
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
5%
Dyspepsia
3%
Akinesia
3%
Diabetes mellitus
3%
Intervertebral disc protrusion
3%
Device migration
3%
Postoperative wound infection
3%
Parkinson's disease
3%
Productive cough
3%
Fluid retention
3%
Skin laceration
3%
Respiratory depression
3%
Joint sprain
3%
Syncope
3%
Ingrowing nail
3%
Rib fracture
3%
Drug withdrawal syndrome
3%
Alcohol poisoning
3%
Contusion
3%
Cerebral microangiopathy
3%
Dysarthria
3%
Hypoaesthesia
3%
Memory impairment
3%
Movement disorder
3%
Monarthritis
3%
Neck pain
3%
Osteoarthritis
3%
Pain in extremity
3%
Spinal osteoarthritis
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%
Diplopia
3%
Macular degeneration
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
2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
rZI + STN stimulation
Group II: 1Experimental Treatment1 Intervention
STN Monopolar Stimulation
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 Colorado, DenverLead Sponsor
1,726 Previous Clinical Trials
2,141,676 Total Patients Enrolled
Drew S Kern, MDPrincipal InvestigatorUniversity of Colorado, Denver
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have other types of movement disorders.You have Parkinson's Disease and have already had a surgery to implant an electrode.People with Parkinson's disease are not eligible.You do not have any deep brain stimulating electrodes in place.
Research Study Groups:
This trial has the following groups:- Group 1: 2
- Group 2: 1
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.
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