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Electrical Stimulation

Electrical Stimulation for Learning and Memory in Alzheimer's and Primary Progressive Aphasia

Verified Trial

N/A

Recruiting

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

Have you had any previous brain injuries (stroke, traumatic brain injury, tumors)?

Are you right-handed?

Timeline

Screening 2 days

Treatment 6 months

Follow Up before intervention, immediately after intervention, 1 month and 3 months post intervention, up to 31 weeks

Awards & highlights

Study Summary

This trial will test if a non-invasive brain stimulation technique can improve verbal learning in Alzheimer's patients.

Who is the study for?

This trial is for right-handed individuals aged 50-75 with a high-school education, proficient in English, and diagnosed with Alzheimer's Disease or Primary Progressive Aphasia. They must have cognitive impairment consistent with AD biomarkers but no history of brain injuries like stroke or tumors.Check my eligibility

What is being tested?

The study tests if electrical brain stimulation (HD-tDCS) combined with a Word List Learning Intervention can improve verbal learning in typical and atypical Alzheimer's patients by comparing active treatment to sham (placebo). It also examines changes in brain connectivity and neurotransmitter levels.See study design

What are the potential side effects?

While the document doesn't specify side effects, tDCS is generally considered safe but may cause mild discomfort, itching, tingling on the scalp during application, headache, fatigue or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a previous brain injury.

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I have been diagnosed with Alzheimer's Disease or Primary Progressive Aphasia.

Timeline

Screening ~ 2 days0 visits

Treatment ~ 6 months30 visits

Follow Up ~ before intervention, immediately after intervention, 1 month and 3 months post intervention, up to 31 weeks

Screening ~ 2 days

Treatment ~ 6 months

Follow Up ~before intervention, immediately after intervention, 1 month and 3 months post intervention, up to 31 weeks

This trial's timeline: 2 days for screening, 6 months for treatment, and before intervention, immediately after intervention, 1 month and 3 months post intervention, up to 31 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 in auditory delayed recall accuracy of semantically related - trained word-lists

Change in auditory delayed recall accuracy of semantically related - untrained word-lists

Change in auditory delayed recall accuracy of semantically unrelated - trained word-lists

+5 more

Secondary outcome measures

Change in Gamma-Aminobutyric Acid (GABA) concentration

Change in Mini Mental State Examination (MMSE)

Change in Mnemonic Similarity Task (MST) score

+22 more

Other outcome measures

Correlation of primary and with sleep efficiency

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sham+word intervention then active HD-tDCS+word interventionExperimental Treatment3 Interventions

Participants will receive Sham + Word List Learning Intervention (WordLLI) and then active HD-tDCS + WordLLI after a three-month washout period.

Group II: Active HD-tDCS+word intervention then Sham+word interventionExperimental Treatment3 Interventions

Participants will receive active HD-tDCS + Word List Learning Intervention (WordLLI) and then receive Sham + WordLLI after a three-month washout period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Active HD-tDCS

2016

N/A

~90

Sham

2013

Completed Phase 3

~2060

0 / 5Eligibility criteria met

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,669 Previous Clinical Trials

28,005,054 Total Patients Enrolled

Johns Hopkins UniversityLead Sponsor

2,259 Previous Clinical Trials

14,820,593 Total Patients Enrolled

Kyrana Tsapkini, PhDPrincipal InvestigatorJohns Hopkins University

6 Previous Clinical Trials

360 Total Patients Enrolled

Media Library

Active HD-tDCS (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04122001 — N/A

Alzheimer's Disease Research Study Groups: Active HD-tDCS+word intervention then Sham+word intervention, Sham+word intervention then active HD-tDCS+word intervention

Alzheimer's Disease Clinical Trial 2023: Active HD-tDCS Highlights & Side Effects. Trial Name: NCT04122001 — N/A

Active HD-tDCS (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04122001 — N/A

Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04122001 — 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 participants are allowed to enroll in this research endeavor?

"Indeed, the information available on clinicaltrials.gov attests to this study's ongoing recruitment process. This trial was first posted in August 1st 2020 and its most recent update happened July 8th 2022; it is searching for 60 patients from a single site."

Answered by AI

Is the eligible age range for this trial above or below 65 years?

"This study only allows participants aged 50 to 75, in accordance with their eligibility criteria."

Answered by AI

Would I be qualified to join this research endeavor?

"This research endeavour is aiming to enroll 60 individuals with Alzheimer's disease between the ages of 50 and 75. Furthermore, participants must pass the following prerequisites: have a minimum high-school education, be right-handed, fit the Mild cognitive impairment or 'possible AD' designation according to 2011 guidelines while also having corresponding biomarkers such as cerebrospinal fluid or PET scans that demonstrate amyloid-beta deposits/FDG uptake with unihemispheric atrophy."

Answered by AI

Are there still slots available for individuals to partake in this research?

"According to clinicaltrials.gov, this patient recruitment is ongoing, with the original post dating back to August 1st 2020 and a recent edit on July 8th 2022."

Answered by AI

What are the key objectives of this medical study?

"This study seeks to quantify changes in auditory recall accuracy and syntactic comprehension, as well as spatial span forward score and verbal fluency task scores. Evaluations will be taken at baseline, directly after intervention, one month post-intervention and three months post-intervention up until a total of 31 weeks have elapsed. Improvements in the measured metrics are seen as beneficial outcomes for participants enrolled in this trial."

Answered by AI