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Behavioural Intervention
Home-based tDCS for Older Adults at Risk of Falling
N/A
Recruiting
Led By Brad Manor, PhD
Research Sponsored by Hebrew SeniorLife
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged 60+
At least 21 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the whole data collection period (~ 6 weeks for phase 2 and ~ 52 weeks for phase 3)
Awards & highlights
Study Summary
This trial is a three-phase feasibility study to explore the remote administration of transcranial direct current stimulation (tDCS) by a caregiver to improve mobility in older adults with recent falls.
Who is the study for?
This trial is for pairs of older adults (60+) at risk of falling and their caregivers who are available weekdays. Participants must have had a fall in the past year or fear future falls, with no severe mobility issues, seizures, certain medical devices, or skin conditions on the scalp.Check my eligibility
What is being tested?
The study tests if caregivers can safely administer tDCS at home to improve mobility in older adults prone to falling. It's divided into three phases: developing training materials, piloting the intervention with 12 pairs, and expanding to up to 18 pairs over a longer period.See study design
What are the potential side effects?
Potential side effects of tDCS may include mild discomfort at the stimulation site on the scalp, headache, fatigue, nausea or itching under electrode pads. These are expected to be similar to those observed in previous lab-based studies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 60 years old or older.
Select...
I am at least 21 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the whole data collection period (~ 6 weeks for phase 2 and ~ 52 weeks for phase 3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the whole data collection period (~ 6 weeks for phase 2 and ~ 52 weeks for phase 3)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Intervention adherence rate ("percent", 0-100, higher ratio means a better outcome)
Screening to enrollment ratio ("percent", 0-100, higher ratio means a better outcome)
Side effects
+1 moreSecondary outcome measures
Change from baseline in Montreal Cognitive Assessment (MoCA) total score (increased score after intervention means a better outcome)
Change from baseline in Timed Up-and-Go (TUG) (reduced time after intervention means a better outcome)
Change from baseline in Trail Making Test B - A (reduced time after intervention means a better outcome)
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: tDCSExperimental Treatment1 Intervention
Active transcranial direct current stimulation (tDCS) will be administered with the goal of facilitating the excitability of the left dorsolateral prefrontal cortex (dlPFC). Electrode placement and current parameters for each electrode have been optimized using a standard brain with the goal of generating an average electric field of 0.25 V/m67 within the left dlPFC. The direct current delivered by any one electrode will not exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
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Who is running the clinical trial?
Hebrew SeniorLifeLead Sponsor
45 Previous Clinical Trials
270,484 Total Patients Enrolled
14 Trials studying Aging
3,804 Patients Enrolled for Aging
Brad Manor, PhDPrincipal InvestigatorHebrew SeniorLife
5 Previous Clinical Trials
355 Total Patients Enrolled
4 Trials studying Aging
211 Patients Enrolled for Aging
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have seizures, use neuro-active drugs, have metal in my head, specific implants, or untreated skin conditions on my scalp.I cannot walk by myself for at least 25 feet.I have fallen in the past year, am worried about falling, or have Parkinson's disease.I am 60 years old or older.I have completed either Phase 1 or 2 of the study with my partner.I have mild memory or thinking problems confirmed by tests.I don't have conditions like poor eyesight or severe arthritis that would prevent me from using a tDCS device properly.I am at least 21 years old.I have completed either Phase 1 or 2 of the study without being excluded.I am available on weekdays to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: tDCS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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 enrolled in this experiment?
"Affirmative. According to information on clinicaltrials.gov, this medical experiment is presently recruiting participants and was first posted on January 25th 2021. The most recent update occurred October 25th 2022, with 72 patients sought from one site."
Answered by AI
Is this clinical trial currently enrolling volunteers?
"According to the clinicaltrials.gov website, this medical trial is open for enrollment; it was originally posted on January 25th 2021 and underwent its latest update on October 25 2022."
Answered by AI
What primary goals have been set forth in this research endeavor?
"The primary focus of this clinical trial, which will take about 6 weeks to complete in its entirety, is the rate of adherence to treatment (between 0-100%, with higher scores indicating desirable outcomes). Secondary objectives include assessing any changes from baseline in mobility function through the Timed Up-and Go Test; cognitive performance via Montreal Cognitive Assessment total score; and dual task cost to gait speed."
Answered by AI
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