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Non-invasive Brain Stimulation
Non-Invasive Brain Stimulation for Lewy Body Dementia (SCAN Trial)
N/A
Recruiting
Led By Benjamin Hampstead, PhD
Research Sponsored by University of Michigan
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 baseline and post-testing (3-4 weeks)
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new method called transcranial direct current stimulation (tDCS) to help people with Lewy body dementias (LBD). LBD patients often have trouble staying alert, and this treatment uses a small electrical current to stimulate certain brain areas. The goal is to see if this can improve their alertness and reduce cognitive issues. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that has been found to enhance cognitive functions in various neurological conditions, including Alzheimer's disease and mild cognitive impairment.
Who is the study for?
This trial is for individuals with Lewy body dementias, specifically those diagnosed with probable DLB or PDD who experience cognitive fluctuations. Participants must be on stable doses of cholinesterase inhibitors for at least four weeks and exhibit certain symptoms like motor signs, attention issues, visual hallucinations, sleep disturbances, smell dysfunction, or autonomic problems.
What is being tested?
The study aims to understand the role of acetylcholine in alertness fluctuations in dementia patients and assesses the potential benefits of HD-tDCS (high-definition transcranial direct current stimulation), a non-invasive brain stimulation technique targeting specific brain regions associated with alertness.
What are the potential side effects?
While not explicitly stated here, common side effects of HD-tDCS may include mild itching, tingling or discomfort at the site of electrode placement during stimulation. There might also be temporary headaches or lightheadedness post-treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and post-testing (3-4 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post-testing (3-4 weeks)
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 on Dementia Cognitive Fluctuations Scale
Secondary study objectives
Change from Baseline Resting State fMRI
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: Experimental: HD-tDCSExperimental Treatment1 Intervention
Maximum 4 milliAmp (mA) per channel of HD-tDCS treatment for 20 minutes, for 10 sessions. Total mA dose determined by individualized computational models.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HD-tDCS
2020
Completed Early Phase 1
~40
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,853 Previous Clinical Trials
6,433,007 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,788 Previous Clinical Trials
28,184,754 Total Patients Enrolled
Benjamin Hampstead, PhDPrincipal Investigator - University of Michigan
University of Michigan
2 Previous Clinical Trials
258 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a significant amount of radiation exposure in the past.You cannot have an MRI if you have a pacemaker or feel very uncomfortable in small spaces.You have signs of a major stroke or a large abnormal growth in your brain as seen on an MRI.Criterion: You are taking certain medications that affect the nervous system.You show signs of atypical parkinsonism during a neurological exam.You have a serious mental illness like bipolar disorder.You have epilepsy, stroke, multiple sclerosis, or a moderate to severe brain injury.You have had a big problem with alcohol or drugs in the recent past.You have trouble seeing or hearing that makes it hard for you to do things.Patients diagnosed with dementia with Lewy bodies based on specific criteria.People with Lewy body dementia (DLB or PDD) who experience changes in thinking and have been taking the same dose of cholinesterase inhibitors for at least 4 weeks.You have symptoms like shaking, trouble focusing, seeing things that aren't there, acting out dreams while asleep, trouble smelling, or problems with body functions like heart rate or digestion.People with Parkinson's disease dementia who have problems with attention, thinking, memory, and also show behavioral symptoms like lack of interest, feeling sad or worried, seeing or hearing things that are not there, or having strong beliefs that are not true.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: HD-tDCS
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.
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