Skip to main content
Clinical Trials/NCT04785053
NCT04785053
Completed
N/A

Improving Memory Functions in Mild Alzheimer's Disease by Transcranial Alternating Current Stimulation

Hebrew SeniorLife1 site in 1 country34 target enrollmentJune 22, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Hebrew SeniorLife
Enrollment
34
Locations
1
Primary Endpoint
Spatiotemporal dynamic changes measured with electroencephalography (EEG)
Status
Completed
Last Updated
last year

Overview

Brief Summary

The overall objective of this project is to examine the effects of non-invasive brain stimulation on episodic memory performance

Detailed Description

A group of 20 cognitively intact younger participants (age 21-35), a group of 20 cognitively intact older participants (age 55+) and an age-matched group of 20 MCI/mild AD participants will be enrolled in the brain stimulation study with behavioral assessments at baseline and post-intervention. All participants will perform a laboratory-based memory task and an autobiographical memory task, followed by the autobiographical interview after the tACS intervention. Each participant will undergo three experimental sessions, applying 20-minute gamma tACS stimulation, theta tACS stimulation or an active sham (control) to the left angular gyrus. Before, during, and after the brain stimulation scalp high-density 257-channels EEG will be recorded to characterize and differentiate brain activity and regional interactions in the three independent groups.

Registry
clinicaltrials.gov
Start Date
June 22, 2020
End Date
September 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hebrew SeniorLife
Responsible Party
Principal Investigator
Principal Investigator

Alvaro Pascual-Leone

Senior Scientist

Hebrew SeniorLife

Eligibility Criteria

Inclusion Criteria

  • Healthy young participants:
  • age 21-35
  • without any cognitive impairment (based on the Montreal Cognitive Assessment: MoCA - in-person screening or Telephone Interview of Cognitive Status: TICS - phone screening)
  • willing and capable to give informed consent for the participation in the study after it has been thoroughly explained able and willing to comply with all study requirements informed consent form (ICF) form was signed
  • Understanding of the ICF will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form . Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
  • Healthy older participants:
  • age 55+ without any cognitive impairment (based in MoCA or TICS)
  • willing and capable to give informed consent for the participation in the study after it has been thoroughly explained able and willing to comply with all study requirements informed consent form was signed
  • Understanding of the ICF will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form. Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
  • Older MCI/mild AD participants:

Exclusion Criteria

  • Healthy young participants:
  • potentially eligible individuals will complete the Telephone Interview of Cognitive Status (TICS) score of ≤31 or any cognitive impairment captured by the Montreal Cognitive Assessment (MoCA) - score \< 26
  • major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
  • blindness or other disabilities that prevent task performance
  • contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp
  • Healthy older participants:
  • potentially eligible individuals will complete the Telephone Interview of Cognitive Status (TICS) with a score of ≤31 or any cognitive impairment captured by the Montreal Cognitive Assessment (MoCA) - score \< 26
  • major psychiatric co-morbidity including major depressive disorder, schizophrenia or psychosis
  • blindness or other disabilities that prevent task performance
  • contraindications to tACS, as recorded on a standardized screening questionnaire, which include a reported seizure within the past two years, use of neuroactive drugs, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp

Outcomes

Primary Outcomes

Spatiotemporal dynamic changes measured with electroencephalography (EEG)

Time Frame: 3 lab-visits will occur at least 2 days apart within one month

Changes in spatiotemporal dynamics in different frequency bands (theta, alpha, beta, gamma) will be assessed with high density - hdEEG after tACS intervention (gamma, theta, sham)

Behavioral performance measured with Montreal Cognitive Assessment (MoCA)

Time Frame: 3 lab-visits will occur at least 2 days apart within one month

Changes in behavioral performance will be assessed using Montreal Cognitive Assessment (MoCA) after tACS intervention (gamma, theta, sham)

Study Sites (1)

Loading locations...

Similar Trials