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Procedure

Deep Brain Stimulation for Parkinson's Disease (DBSMER Trial)

N/A
Waitlist Available
Led By Francisco A Ponce, MD
Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operative; intra-operative ; 10-14 post-operative; 12 week post-operative; 6 months post-operative
Awards & highlights

DBSMER Trial Summary

This trial will be studying the neural recordings from the sub-cortical structures and the cerebral cortex in order to better understand Parkinson's disease and the mechanism of Deep Brain Stimulation surgery.

DBSMER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-operative; intra-operative ; 10-14 post-operative; 12 week post-operative; 6 months post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative; intra-operative ; 10-14 post-operative; 12 week post-operative; 6 months post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neural Recordings

Side effects data

From 2018 Phase 2 trial • 53 Patients • NCT01221948
23%
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

DBSMER Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep Brain StimulationExperimental Treatment1 Intervention
After informed consent is obtained, the patients will undergo routine DBS pre-operative evaluation and diagnostic testing. This includes a pre-operative 3T-MRI with and without gadolinium as well as pre-operative medical clearance by the patient's PCP or general practitioner and/or other medical specialist if necessary. They will also receive a baseline clinical evaluation including both motor function (Unified Parkinson's Disease Rating Scale on and off anti-parkinsonian medication) quality of life assessment (Parkinson's disease Questionnaire-39) and a full neuropsychological evaluation, if not already completed as part of the routine DBS candidacy evaluation within 2 months of surgery. Subjects will have medical clearance from their specialists and be be evaluated by an internal medicine physician prior to surgery and cleared to proceed.
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?

Arizona State UniversityOTHER
283 Previous Clinical Trials
109,480 Total Patients Enrolled
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
63 Previous Clinical Trials
14,583 Total Patients Enrolled
Francisco A Ponce, MDPrincipal InvestigatorBarrow Brain and Spine physician with SJHMC privileges
6 Previous Clinical Trials
5,052 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Electrophysiological Recordings of Deep Brain Stimulation in the Basal Ganglia
Markey Olson 2016. "Electrophysiological Recordings of Deep Brain Stimulation in the Basal Ganglia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03088592.
~4 spots leftby Apr 2025
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