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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 • NCT0122194823%
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
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
~700
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,380 Previous Clinical Trials
1,588,721 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have another important neurological condition.I have been diagnosed with Parkinson's disease.I have a condition that greatly affects my ability to move my arms or legs.You have a history of memory problems or difficulty thinking clearly.I have had complications or side effects after surgery.You have already had a 7T brain scan.I have had surgery to implant brain stimulators in specific brain areas.I have been diagnosed with Parkinson's disease.I have had surgery to implant brain stimulators in specific brain areas.
Research Study Groups:
This trial has the following groups:- Group 1: Parkinson's disease with DBS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment currently recruiting participants?
"Affirmative. The details posted on clinicaltrials.gov indicate that this medical experiment is actively recruiting, having been initially published on August 25th 2016 and recently updated November 4th 2022. 24 patients need to be enrolled at a single location for the trial's completion."
Answered by AI
Am I eligible to join in this research endeavor?
"This trial is seeking 24 people with Parkinson's disease (PD) between 18 and 89 years old. The main requirements for applicants are a diagnosis of idiopathic PD, 7T brain imagery, and deep brain stimulators implanted in either the globus pallidus or subthalamic nucleus."
Answered by AI
Does this research involve elderly individuals?
"The patient selection criteria for this clinical trial mandates that individuals must be between 18 and 89 years old. There are 27 trials available to those under the age of majority, while 484 studies can accommodate participants over 65 years old."
Answered by AI
How many people are taking part in this experiment?
"Correct. According to clinicaltrials.gov, this trial is still recruiting patients; it was initially posted on August 25th 2016 and most recently updated on November 4th 2022. The project seeks to enrol 24 participants from a single medical centre."
Answered by AI
Who else is applying?
What state do they live in?
Ontario
California
What site did they apply to?
University Of Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
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