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Behavioural Intervention
tDCS + Cognitive Training for Dementia
N/A
Waitlist Available
Led By Kyrana Tsapkini, PhD
Research Sponsored by Johns Hopkins University
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 before intervention, immediately after intervention
Awards & highlights
Summary
This trial tests if non-invasive brain stimulation and computerized cognitive training can improve executive functioning in people with PPA, MCI or dementia.
Who is the study for?
This trial is for right-handed individuals who have been clinically diagnosed with Primary Progressive Aphasia (PPA), Frontotemporal Dementia (FTD), Mild Cognitive Impairment (MCI) or mild Alzheimer's Disease, based on neuropsychological and language testing, MRI scans, and clinical assessment. Participants must speak English fluently and have at least a high-school education. Those with uncorrected vision/hearing issues, other learning disorders, inability to follow directions, severe psychiatric conditions or previous neurological disorders like stroke are excluded.
What is being tested?
The study tests the effects of non-invasive brain stimulation using transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex combined with computerized cognitive training from BrainHQ. The goal is to improve executive functioning in patients with PPA associated with FTD or Alzheimer's Disease pathology as well as those with MCI/Alzheimer's Disease.
What are the potential side effects?
Potential side effects of tDCS may include discomfort at the electrode site such as itching or tingling during application, headache, fatigue after treatment sessions, nausea or insomnia. However individual experiences can vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ before intervention, immediately after intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before intervention, immediately after intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Executive Composite Outcome
Change in Global Cognitive Scores
Change in language composite outcome
Secondary study objectives
Change in Selective attention and cognitive flexibility
Change in attention and task switching
Change in level of Depressive Symptoms
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Active tDCS on the DLPFC onlyExperimental Treatment1 Intervention
Participants will receive active tDCS on the DLPFC-only intervention first and then receive active tDCS + Cognitive Intervention(s) after a three-month washout period.
Group II: Active tDCS on the DLPFC + Cognitive Intervention(s)Experimental Treatment2 Interventions
Participants will receive active tDCS on DLPFC + Cognitive Intervention(s) first and then receive only active tDCS Intervention after a three-month washout period.
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Who is running the clinical trial?
Ybrain Inc.Industry Sponsor
11 Previous Clinical Trials
636 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,859 Total Patients Enrolled
Kyrana Tsapkini, PhDPrincipal InvestigatorJohns Hopkins University
6 Previous Clinical Trials
430 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stroke or another brain disorder.I cannot follow instructions for basic tasks.I have been diagnosed with PPA, FTD, MCI, or mild Alzheimer's based on tests and assessments.
Research Study Groups:
This trial has the following groups:- Group 1: Active tDCS on the DLPFC + Cognitive Intervention(s)
- Group 2: Active tDCS on the DLPFC only
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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