Recruiting

Home-based Neuromodulation

Sponsor:

Hebrew SeniorLife

Code:

NCT05976659

Conditions

Major Depressive Disorder

Alzheimer Disease

Dementia

Nervous System Diseases

Memory Disorders

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS)

Study Details

Brief summary:

This project aims to explore the feasibility and effects of a symptom-specific, brain-circuit-based, home-based neuromodulation therapy for addressing mood and memory symptoms in older adults with major depressive disorder (MDD) in the context of dementia.

Conditions

Major Depressive Disorder

Alzheimer Disease

Dementia

Nervous System Diseases

Memory Disorders

Study ID

NCT05976659

Start date

Jan 24, 2023

Status verified date

Mar, 2023

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Jan 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants (Ps)

  • 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
  • an informed consent form was signed
  • able to read, write, and communicate in English
  • able to identify an eligible administrator to participate with them in the study Caregiver/Administrators (As)
  • at least 21 years of age
  • able to read, write, and communicate in English
  • self-reported computer proficiency and willingness to learn how to use tES as defined by "yes" answers to the questions "Do you feel comfortable using a computer?" and "Are you willing to be the primary caregiver for a participant and learn how to administer tES?"
  • stated availability during weekdays throughout the study period to administer tES to the participant

Exclusion Criteria:

  • contraindications to tES, 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, etc.)
  • the presence of any active dermatological condition, such as eczema, on the scalp a score of 18 or less on the Montreal Cognitive Assessment (MoCA) during the in-person screen
  • blindness or other disabilities that prevent task performance
  • an inability to understand study procedures following review of the Informed Consent form
  • Understanding 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 Caregiver/Administrators (As)
  • mild cognitive impairment defined by a MoCA score ≤26 during the in-person screen
  • insufficient understanding of study procedures following review of the Informed Consent form Understanding 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.
  • poor eyesight, severe arthritis in the hands, pain, deformity or other condition that interferes with successful administration of tES

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: tDCS prefrontal cortex + tASC angular gyrus in MDD in the context of AD

Participants will undergo 20 sessions of home-based tDCS over the prefrontal cortex and tACS over the left angular gyrus.These sessions will take place five times a week for four weeks, with one daily stimulation session of no more than 20 minutes. The participant's home will be the setting for the completion of the brain stimulation intervention, which will be delivered by trained caregivers/study companions/administrators.

Interventions

Transcranial direct current stimulation (tDCS); Transcranial alternating current stimulation (tACS)

Transcranial electrical stimulation (tES), via direct and alternating current, will be administered to the participants in their home by trained caregivers/study companions administrators. All training and intervention sessions will take place in the participant's home.

Primary outcome measure

  • Geriatric Depression Scale-15 Items (GDS-15) [ Time Frame: Change from Baseline GDS-15 total score at immediate post-intervention follow-up ]
  • Rey Auditory Verbal Learning Test (RAVLT) Total Recall [ Time Frame: Change from Baseline RAVLT Total Recall total score at immediate post-intervention follow-up ]

Central Contacts and Locations

Central contacts

HomeStim Study

617-971-5415MoodMemStim@hsl.harvard.edu

Locations

Hinda and Arthur Marcus Institute for Aging Research

Recruiting

Boston, Massachusetts, United States, 02131

Contacts

Rachel Fox, BS

617-971-5415rachelfox@hsl.harvard.edu

Principal Investigator:

Davide Balos Cappon, MS; PhD

More Information

Sponsor

Hebrew SeniorLife

Last update posted

Aug 4, 2023

Last verified

Mar, 2023

Keywords

  • Major Depressive Disorder
  • Alzheimer's Disease
  • Transcranial Direct Current Stimulation
  • Transcranial Alternating Current Stimulation
  • Memory
  • Brain Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hebrew SeniorLife on 2023-08-04.