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Procedure

Deep Brain Stimulation for Movement Disorders

N/A
Recruiting
Led By Nicole Bentley, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eligible for DBS surgery based on multi-disciplinary consensus review
Have a diagnosis of Parkinson's disease or Essential Tremor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-6 months
Awards & highlights

Study Summary

This trial is investigating the differences in brain activity between patients with PD or essential tremor and healthy controls. They will be looking at both motor and non-motor symptoms and how they are associated with changes in brain activity.

Who is the study for?
This trial is for adults over 18 with Parkinson's disease or Essential Tremor who are eligible for Deep Brain Stimulation (DBS) surgery. Candidates should be willing to participate in the study activities and have tried standard medical treatments without enough improvement.Check my eligibility
What is being tested?
The study investigates brain activity related to motor and non-motor symptoms of movement disorders during routine DBS surgery. It aims to understand changes in brain function associated with symptoms like depression, cognitive issues, and speech problems.See study design
What are the potential side effects?
Since this research focuses on observation during DBS surgery rather than a new treatment, side effects relate primarily to typical risks of DBS such as infection, headache, confusion, speech issues, or unwanted movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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A team of doctors agrees I am a candidate for DBS surgery.
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I have been diagnosed with Parkinson's disease or Essential Tremor.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy via Simon Task (% correct)
Dementia Rating Scale Score (0-144 points)
Response times via Simon Task (sec)
+3 more
Secondary outcome measures
Comparison of hemispheric differences in power spectral density (p-value, parametric two-tailed t-test)
Other outcome measures
Electroencephalography

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Parkinson's Disease Patients receiving DBS electrodes
Group II: ControlActive Control1 Intervention
Control subjects will be non-Parkinson's Disease patients with essential tremor

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,571 Previous Clinical Trials
2,269,321 Total Patients Enrolled
3 Trials studying Movement Disorders
88 Patients Enrolled for Movement Disorders
Nicole Bentley, MD5.014 ReviewsPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham
1 Previous Clinical Trials
90 Total Patients Enrolled
5Patient Review
Definitely professional and knowledgable.

Media Library

Deep Brain Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04061135 — N/A
Movement Disorders Research Study Groups: Treatment, Control
Movement Disorders Clinical Trial 2023: Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT04061135 — N/A
Deep Brain Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04061135 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people have taken part in this clinical experiment thus far?

"Affirmative. Clinicaltrials.gov has documented that this clinical trial is actively searching for participants. It was posted on September 1st, 2019 and the latest modification took place on April 7th, 2022; 60 patients are required at a single medical site to complete the study."

Answered by AI

What benefits are researchers expecting to glean from this investigation?

"Over a 3-month period, the aim of this trial is to evaluate prefrontal time-frequency spectrogram. Secondary outcome metrics include accuracy via Simon Task (% correct), calculated as the difference in performance between congruent and incongruent trials. Lastly, we will assess UPDRS 3 motor score (0-108)."

Answered by AI

Is there still capacity for individuals to participate in this trial?

"Affirmative. Clinicaltrials.gov records state that this medical trial, which was initially published on September 1st 2019, is actively recruiting participants. Around 60 volunteers are needed to be recruited across a single site."

Answered by AI
~16 spots leftby Mar 2025