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Deep Brain Stimulation

Deep brain stimulation for Dystonia (ADROIT Trial)

N/A
Recruiting
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 5 years
Awards & highlights

Summary

The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.

Eligible Conditions
  • Dystonia
  • Tremor
  • Parkinson's Disease
  • Movement Disorders
  • Essential Tremor
  • Primary Dystonia

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline to 1 year in disease-specific motor rating scale. For subjects with cervical dystonia, TWSTRS severity scale.
Change from baseline to 1 year in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS.
Change from baseline to 1 year in disease-specific motor rating scale. For subjects with dystonia (except for cervical dystonia), BFMDRS movement scale.
+27 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Deep brain stimulationExperimental Treatment1 Intervention
Subjects implanted with an Abbott DBS system
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Deep Brain Stimulation (DBS)
2011
Completed Phase 3
~50

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
647 Previous Clinical Trials
407,534 Total Patients Enrolled
1 Trials studying Dystonia
71 Patients Enrolled for Dystonia
Marie FaheyStudy DirectorAbbott Medical Devices Neuromodulation
4 Previous Clinical Trials
671 Total Patients Enrolled
Edward KarstStudy DirectorAbbott
5 Previous Clinical Trials
196 Total Patients Enrolled
~504 spots leftby Sep 2029
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