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tDCS for Alzheimer's Disease
N/A
Recruiting
Led By Kendra M Anderson, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
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, week 2, week 4, week 6, 6 weeks post treatment
Awards & highlights
Study Summary
This trial is testing whether a non-invasive brain stimulation technique is safe and effective for treating behavioral symptoms in patients with Alzheimer's Disease and Related Dementias.
Who is the study for?
This trial is for individuals with Alzheimer's Disease and related dementias who show behavioral symptoms. Participants must have a caregiver willing to join the study, stable medication doses for at least one month, and be able to speak and read English. It's not suitable for those with unstable medical conditions, brain surgery history, seizures, metal in their head from past surgeries or substance abuse issues.Check my eligibility
What is being tested?
The trial is testing home-based Transcranial Direct Current Stimulation (tDCS) on patients with Alzheimer’s-related behavioral symptoms. The goal is to see if tDCS is easy to use at home, safe for these patients, and effective in reducing their behavioral issues.See study design
What are the potential side effects?
Potential side effects of tDCS may include mild discomfort at the stimulation site on the scalp, itching or tingling during treatment sessions, fatigue or headache after treatment. Serious side effects are rare but can include seizure or skin burns.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 2, week 4, week 6, 6 weeks post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 2, week 4, week 6, 6 weeks post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of the tDCS treatment as assessed by the tDCS acceptability questionnaire
safety as assessed by the side effects questionnaire
Secondary outcome measures
Change in apathy as assessed by the Brief Dimensional Apathy Scale (b-DAS)
Change in cognition as evaluated by the Mini-Mental State Examination (MMSE)
Change in dementia-related behavioral symptoms as assessed by the Neuropsychiatric Inventory (NPI-Q) scale
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: active tDCSExperimental Treatment1 Intervention
All participants will receive active tDCS with a constant current intensity of 2mA. Anodal tDCS will be applied to the left dorsolateral prefrontal cortex, while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex. Caregivers will help setting up and administering tDCS for participants with AD at home. tDCS will be applied for 30min at an intensity of 2mA, with 30 s ramping up and down.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
active tDCS
2018
N/A
~790
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
904 Previous Clinical Trials
320,940 Total Patients Enrolled
Texas Alzheimer's Research & Care Consortium (TARCC)UNKNOWN
Kendra M Anderson, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Alzheimer's or dementia with significant behavioral symptoms.I have had brain surgery in the past.My medication doses have been stable for at least a month.I do not have any unstable health conditions.I have a history of seizures.
Research Study Groups:
This trial has the following groups:- Group 1: active 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the purpose of conducting this medical research?
"The purpose of this 12 week analysis is to assess the safety of a drug based on its side-effects. Further, The Brief Dimensional Apathy Scale (b-DAS), Cornell Scale for Depression in Dementia (CSDD) and Mini Mental State Examination (MMSE) will be used as secondary metrics to evaluate changes in apathy, depressive symptoms and cognition respectively; with higher scores indicating improved outcomes across all three measures."
Answered by AI
Is there an opportunity for patient participation in this experiment?
"According to the information on clinicaltrials.gov this trial is no longer actively recruiting participants, with initial posting occuring on August 1st 2022 and last update occurring July 28th 2022. Nevertheless, there are currently 785 other studies in search of patients presently."
Answered by AI
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