Feasibility of Home-based tES for Older Adults at Risk of Falling

Summary

In this project, the investigators propose to demonstrate the feasibility of remotely-monitored, caregiver (or spouse)-administered, home-based tES (transcranial electrical stimulation) intervention to improve mobility in ambulatory older adults with recent falls. This is a four-phase feasibility study in older, ambulatory adult participants at risk of falling due to a loss of balance (participant faller, PF) together with a willing and able participant administrator (PA) that is available during weekdays to administer tES to the PF.

Phase 1 is focused on the development and refinement of our training materials for home-based tDCS (transcranial direct current stimulation) for PF/PA pairs. The objectives of this phase:

1. Identify areas of confusion and challenges for older adults.
2. Refine our training materials to accompany the home-based tDCS system.

In Phase 2, the investigators will complete a pilot trial in 12 PF/PA pairs to assess the feasibility of deploying home-based tES in larger clinical trials, and to prepare for the development and implementation of such trials. The objectives of this phase:

1. Determine the mean/range number of visits needed for in-person training.
2. Compliance and retention with the study protocol.
3. Safety/side effects of home-based tES, as compared to previously established laboratory-based tES data.

The investigators hypothesize that adult PAs are able to successfully administer home-based tES to PFs. The investigators also expect that PF/PA pairs will exhibit excellent adherence to the intervention and that the prevalence and severity of reported tDCS side-effects will be similar to that observed in previous laboratory-based studies.

In Phase 3, the investigators will complete a pilot trial in up to 18 PF/PA pairs; i.e., those who have previously successfully completed either Phase 1 or Phase 2. The study objectives/aims for Phase 3 are:

1. Further explore compliance and retention with the study protocol over a longer time period
2. Identify safety/side effects of home-based tES over a longer time-period as compared to previously established laboratory-based tDCS interventions.

In Phase 3, the investigators hypothesize that adult PA's who have previously demonstrated the ability to successfully administer tES at home, will retain competence and compliance with administration over a longer period, up to 1 year.

In Phase 4, we will complete a pilot trial in up to 18 PF/PA teams; those who have previously successfully completed Phase 3. The study objective/aims for Phase 4 will be to:

1. Identify Safety, effectiveness and adherence to home-based tES over longer period of time as compared to previously established laboratory-based tES interventions.
2. Further explore the proof of Concept for the home-based tES interventions

In Phase 4 we hypothesize that adult PA's who have previously demonstrated the ability to successfully administer tES at home, will adhere with the study protocol over a longer period of time, up to 3 years.

Conditions

• Aging
• Accidental Falls

Interventions

OTHER

tES (transcranial electrical stimulation)

Phase 1: The participant will receive 10, 20-minute sessions of tDCS on Monday-Friday, at approximately the same time of day, over two consecutive weeks. Phase 2: The participant will receive 22, 20-minute sessions of tES. 10 sessions will take place over the first two weeks on Monday-Friday, at approximately the same time of day. This will be followed by 3 tES sessions per week over four weeks. Phase 3: The participant will receive up to 260, 20-minute sessions of tES. The participant can complete up to 5 tDCS sessions per week over 52 weeks. Phase 4: The participant will receive up to 780, 20-minute sessions of tES. The participant can complete up to 5 tDCS sessions per week over 156 weeks.

Sponsors & Collaborators

• Hebrew SeniorLife

  lead OTHER

Principal Investigators

• Brad Manor, PhD · Hebrew SeniorLife

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-25

Primary Completion

2027-01-30

Completion

2027-12-30

Countries

• United States

Study Locations