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Deep Brain Stimulation
Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia
Phase 1
Waitlist Available
Led By Chris Honey, MD,DPhil,FRCSC
Research Sponsored by University of British Columbia
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 up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
Dystonia is increasingly being considered as a multi-nodal network disorder involving both basal ganglia and cerebellar dysfunction. The aim of this study is to determine if "Multi-Target" Thalamic and Pallidal Deep Brain Stimulation improves hemi-dystonia patients who are receiving inadequate therapy from GPi DBS.
Eligible Conditions
- Dystonia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side 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%
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%
Contusion
3%
Joint sprain
3%
Diabetes mellitus
3%
Macular degeneration
3%
Diplopia
3%
Pain in extremity
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
Active Control
Group I: Thalamic (Vim) Deep Brain StimulationExperimental Treatment1 Intervention
Vim is the standard target to treat cerebellar dysfunction in movement disorders. It is not routinely used in secondary dystonia
Group II: GPi + Vim (Multi-Target) Deep Brain StimulationExperimental Treatment1 Intervention
Combined stimulation of GPi and Vim stimulation (both electrodes ON)
Group III: Pallidal (GPi) Deep Brain StimulationActive Control1 Intervention
GPi is the standard target for treating most dystonia. This setting will be the active comparator
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?
University of British ColumbiaLead Sponsor
1,481 Previous Clinical Trials
2,494,912 Total Patients Enrolled
1 Trials studying Dystonia
6 Patients Enrolled for Dystonia
Chris Honey, MD,DPhil,FRCSCPrincipal InvestigatorUniversity of British Columbia