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Device

Deep Brain Stimulation (DBS) Retrospective Outcomes Study

N/A
Recruiting
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Must be previously treated with or eligible for implantation with a deep brain stimulation system
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 yrs. post implant
Awards & highlights
No Placebo-Only Group

Summary

The primary objective of this study is to characterize real-world clinical outcomes of Deep Brain Stimulation (DBS) using retrospective review of de-identified patient records.

Eligible Conditions
  • Dystonia
  • Dementia
  • Essential Tremor
  • Parkinson's Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 yrs. post implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 yrs. post implant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III) at up to 5 years post implant compared to baseline

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%
Back pain
5%
Dyspepsia
5%
Skeletal injury
5%
Head injury
5%
Speech disorder
5%
Tremor
5%
Gait disturbance
5%
Dystonia
5%
Paraesthesia
5%
Influenza
5%
Urinary tract infection
3%
Postoperative wound infection
3%
Hypoaesthesia
3%
Spinal osteoarthritis
3%
Productive cough
3%
Macular degeneration
3%
Contusion
3%
Joint sprain
3%
Diplopia
3%
Pain in extremity
3%
Diabetes mellitus
3%
Ingrowing nail
3%
Osteoarthritis
3%
Intervertebral disc protrusion
3%
Alcohol poisoning
3%
Fluid retention
3%
Device migration
3%
Skin laceration
3%
Akinesia
3%
Parkinson's disease
3%
Syncope
3%
Respiratory depression
3%
Rib fracture
3%
Drug withdrawal syndrome
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

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
Group I: Parkinson's DiseaseExperimental Treatment1 Intervention
Subjects with Parkinson's disease, implanted with a Boston Scientific Deep Brain Stimulation System
Group II: Essential TremorExperimental Treatment1 Intervention
Subjects with Essential Tremor, implanted with a Boston Scientific Deep Brain Stimulation System
Group III: DystoniaExperimental Treatment1 Intervention
Subjects with dystonia, implanted with a Boston Scientific Deep Brain Stimulation System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation
2011
Completed Phase 2
~710

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
746 Previous Clinical Trials
852,989 Total Patients Enrolled
3 Trials studying Dystonia
680 Patients Enrolled for Dystonia
Roshini JainStudy DirectorBoston Scientific Neuromodulation Corporation
30 Previous Clinical Trials
21,295 Total Patients Enrolled
1 Trials studying Dystonia
300 Patients Enrolled for Dystonia
Natalie Bloom LyonsStudy DirectorBoston Scientific Neuromodulation Corporation
16 Previous Clinical Trials
19,810 Total Patients Enrolled
1 Trials studying Dystonia
300 Patients Enrolled for Dystonia
~1983 spots leftby Dec 2028
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