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Deep Brain Stimulation

Deep Brain Stimulation for Parkinson's Disease

N/A
Recruiting
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
diagnosis of idiopathic PD
Have undergone neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN)
Must not have
History of musculoskeletal disorders that significantly affect movement of the upper or lower limbs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether deep brain stimulation can help improve motor symptoms in Parkinson's disease.

Who is the study for?
This trial is for people with Parkinson's disease who have had surgery to implant deep brain stimulators in the globus pallidus or subthalamic nucleus. They must also have existing 7T brain images. It's not open to those with musculoskeletal disorders affecting limb movement, other neurological disorders, dementia, cognitive impairment, or post-operative complications.
What is being tested?
The study is examining how different locations of deep brain stimulation (DBS) within the globus pallidus affect motor symptoms in Parkinson's patients. The goal is to see if targeting specific areas can improve symptoms that don't respond well to medication.
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort at the stimulation site, speech problems, balance issues and mood changes due to DBS adjustments during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Parkinson's disease.
Select...
I have had surgery to implant brain stimulators in specific brain areas.
Select...
I have been diagnosed with Parkinson's disease.
Select...
I have had surgery to implant brain stimulators in specific brain areas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a condition that greatly affects my ability to move my arms or legs.

Timeline

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in the combined elastic, viscous and inertial resistance across conditions will be assessed by integrating the resistive torque

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%
Dyspepsia
5%
Back pain
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%
Osteoarthritis
3%
Postoperative wound infection
3%
Diabetes mellitus
3%
Ingrowing nail
3%
Pain in extremity
3%
Intervertebral disc protrusion
3%
Hypoaesthesia
3%
Spinal osteoarthritis
3%
Diplopia
3%
Contusion
3%
Productive cough
3%
Macular degeneration
3%
Joint sprain
3%
Fluid retention
3%
Alcohol poisoning
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

1Treatment groups
Experimental Treatment
Group I: Parkinson's disease with DBSExperimental Treatment1 Intervention
Participants will have a diagnosis of idiopathic PD and have undergone/will undergo neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN)
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 MinnesotaLead Sponsor
1,439 Previous Clinical Trials
1,621,934 Total Patients Enrolled

Media Library

Deep Brain Stimulation (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05557864 — N/A
Parkinson's Disease Research Study Groups: Parkinson's disease with DBS
Parkinson's Disease Clinical Trial 2023: Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT05557864 — N/A
Deep Brain Stimulation (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05557864 — N/A
~3 spots leftby Dec 2025
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