Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 1:27 PM
Study NCT ID:
NCT04732533
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2021-01-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Home-based tES for Older Adults at Risk of Falling
Sponsor:
Hebrew SeniorLife
Organization:
Study Overview
Official Title:
Feasibility of Home-based tES for Older Adults at Risk of Falling
Status:
RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
In older adults, falls are costly, consequential and correlated with both physical and cognitive decline. Most falls occur when standing or walking, especially when completing these tasks in complex environments or while simultaneously performing additional cognitive tasks. To this end, older adults with worse cognitive "executive" function have worse mobility and are more likely to fall.
Transcranial Electrical Stimulation (tES), which includes both transcranial Direct Current Stimulation (tDCS) and transcranial Alternating Current Stimulation (tACS), holds promise as a therapy to improve dual task standing and walking and other "high-level" aspects of mobility in older adults. tES is a low cost technique, is very safe with only minimal side effects, is portable and is very easy to administer. However, tES must be administered numerous times per week for several consecutive weeks in order to induce lasting therapeutic benefit. As each tES session must currently be administered in clinical or laboratory settings, such interventions are not currently available to many older adults--especially those who 1) live far away from the clinical/laboratory, and/or 2) have physical and/or cognitive limitations that make it difficult to organize and utilize transportation.
Transcranial Electrical Stimulation (tES), which includes both transcranial Direct Current Stimulation (tDCS) and transcranial Alternating Current Stimulation (tACS), holds promise as a therapy to improve dual task standing and walking and other "high-level" aspects of mobility in older adults. tES is a low cost technique, is very safe with only minimal side effects, is portable and is very easy to administer. However, tES must be administered numerous times per week for several consecutive weeks in order to induce lasting therapeutic benefit. As each tES session must currently be administered in clinical or laboratory settings, such interventions are not currently available to many older adults--especially those who 1) live far away from the clinical/laboratory, and/or 2) have physical and/or cognitive limitations that make it difficult to organize and utilize transportation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| Pro00044339 | OTHER | Advarra IRB | View |