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Non-invasive Brain Stimulation

Non-Invasive Brain Stimulation for Lewy Body Dementia (SCAN Trial)

N/A
Waitlist Available
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
LBD patients (DLB or PDD) with cognitive fluctuations and stable doses of cholinesterase inhibitors for at least 4 weeks
Subjects identified with recognized DLB features: spontaneous parkinsonian motor signs, fluctuating attention and concentration, recurrent well-formed visual hallucinations, presence of REM behavioral sleep disturbance, anosmia/hyposmia, or autonomic dysfunction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post-testing (3-4 weeks)
Awards & highlights
No Placebo-Only Group

SCAN Trial Summary

This trial will test whether stimulating certain brain regions with a non-invasive method can help reduce fluctuations in alertness for people with Lewy body dementias, which are a major source of disability.

Eligible Conditions
  • Lewy Body Disease
  • Lewy Body Dementia

SCAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.
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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.
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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.
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Patients diagnosed with dementia with Lewy bodies based on specific criteria.

SCAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and post-testing (3-4 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post-testing (3-4 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline on Dementia Cognitive Fluctuations Scale
Secondary outcome measures
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.

SCAN 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
2021
Completed Early Phase 1
~50

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,768 Previous Clinical Trials
6,583,903 Total Patients Enrolled
1 Trials studying Lewy Body Disease
16 Patients Enrolled for Lewy Body Disease
National Institute on Aging (NIA)NIH
1,637 Previous Clinical Trials
28,001,694 Total Patients Enrolled
29 Trials studying Lewy Body Disease
22,818 Patients Enrolled for Lewy Body Disease
Benjamin Hampstead, PhDPrincipal Investigator - University of Michigan
University of Michigan
2 Previous Clinical Trials
258 Total Patients Enrolled

Media Library

HD-tDCS (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04817891 — N/A
Lewy Body Disease Research Study Groups: Experimental: HD-tDCS
Lewy Body Disease Clinical Trial 2023: HD-tDCS Highlights & Side Effects. Trial Name: NCT04817891 — N/A
HD-tDCS (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04817891 — N/A

Frequently Asked Questions

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

Does this research endeavor extend to individuals who possess an age of sixty-five or above?

"To be considered for this investigation, applicants must fall within the range of 50 to 90 years old. Alternatively, there are 93 trials available for those younger than 18 and 813 studies suitable for aged individuals over 65."

Answered by AI

Do I qualify to join this scientific experiment?

"This trial seeks 18 participants between the age of 50 and 90 diagnosed with Lewy Body Disease. Additionally, these individuals must be on a stable dosage of cholinesterase inhibitors for at least 4 weeks prior to enrollment and meet either DLB or PDD criteria as defined by Emre et al. Specifically, those seeking inclusion in this study should demonstrate cognitive deficits in two out of four domains (attention, executive functions, visuo-spatial functions, free recall memory) plus one behavioral symptom such as apathy; however lack of behavioural symptoms does not bar them from participating. Other exclusionary conditions include coexistence of any abnorm"

Answered by AI

What is the aggregate number of individuals involved in this trial?

"Affirmative. According to clinicaltrials.gov, this research endeavor is presently recruiting participants; the trial was initially posted on May 3rd 2021 and last updated on November 7th 2022. The study requires 18 individuals at 2 distinct sites to take part in it."

Answered by AI

Are applications being accepted at this time for participation in the trial?

"Affirmative. Data posted on clinicaltrials.gov affirms that this medical trial, initially published on May 3rd 2021, is recruiting participants at the present time. A total of 18 patients need to be recruited from two separate sites."

Answered by AI
~2 spots leftby Feb 2025