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Behavioural Intervention

tDCS for Preventing Falls in Elderly

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
Self-report of mobility and balance problems
Trail Making Test (TMT) Part B time below 75th percentile of age-and education-based norms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-day follow-up; 3-month follow-up; 6-month follow-up
Awards & highlights

Study Summary

This trial will test whether a four-week intervention of personalized transcranial direct current stimulation improves dual task standing and walking performance, physical factors, and cognitive factors in older adults who report fear of falling.

Who is the study for?
This trial is for adults aged 60 or older who have fallen twice in the past year, are worried about falling again, and have mobility and balance issues. They must score below a certain level on physical performance tests but can't join if they've had recent heart attacks, active cancer treatments, severe mental health conditions, blindness, contraindications to MRI or tDCS like seizures or metal implants, dementia, sedative use changes recently, inability to stand/walk unassisted for a minute.Check my eligibility
What is being tested?
The study tests whether personalized transcranial direct current stimulation (tDCS) over four weeks improves standing/walking tasks while doing another task (like counting backwards), physical abilities and cognitive functions related to fall risk in elderly with fear of falling. It compares this method against a sham intervention using various performance measures.See study design
What are the potential side effects?
Potential side effects of tDCS may include mild tingling at the electrode sites during application, itching under the electrodes placement area, fatigue after treatment sessions, headache following stimulation session and nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have issues with moving around and keeping my balance.
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My Trail Making Test result is within the normal range for my age and education.
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I am 60 years old or older.
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I am worried about falling in the future.
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My physical performance score is 10 or below.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-day follow-up; 3-month follow-up; 6-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-day follow-up; 3-month follow-up; 6-month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in Short Physical Performance Battery (SPPB)
Change from baseline in Trail Making Test B - A
Change from baseline in the dual task cost to gait speed
+1 more
Secondary outcome measures
Change from baseline in 5-day accelerometry-based habitual physical activity
Change from baseline in Category and Phonemic Fluency Test
Change from baseline in Digit Span
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Personalized tDCSExperimental Treatment1 Intervention
Personalized tDCS: This intervention is designed to facilitate the excitability of 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.
Group II: Active-ShamPlacebo Group1 Intervention
The investigators will use an active sham in which very low-level currents (0.5 mA total) will be transferred between electrodes in close proximity on the scalp throughout the entire 20-minute session. This intervention will be optimized to each participant to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS.

Find a Location

Who is running the clinical trial?

Hebrew SeniorLifeLead Sponsor
45 Previous Clinical Trials
270,436 Total Patients Enrolled
14 Trials studying Aging
3,756 Patients Enrolled for Aging
Brad Manor, PhDPrincipal Investigator - Hebrew SeniorLife
Hebrew SeniorLife
5 Previous Clinical Trials
307 Total Patients Enrolled
4 Trials studying Aging
163 Patients Enrolled for Aging

Media Library

Personalized tDCS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03814304 — N/A
Aging Research Study Groups: Personalized tDCS, Active-Sham
Aging Clinical Trial 2023: Personalized tDCS Highlights & Side Effects. Trial Name: NCT03814304 — N/A
Personalized tDCS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03814304 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial include seniors as participants?

"Based on the listed requirements for this scientific trial, eligible individuals must be between 60 and 100 years of age."

Answered by AI

What is the threshold for participation in this clinical investigation?

"Affirmative. According to clinicaltrials.gov, recruitment is currently underway for this medical research project which was initially posted on July 8th 2019 and updated lastly on August 1st 2022. The team needs 120 volunteers from one particular centre in order to complete the trial."

Answered by AI

In what ways is this trial hoping to achieve its stated aims?

"This medical trial, which involves follow-ups at 3 days, 3 months and 6 months post-treatment, will measure the change from baseline in dual task cost to gait speed. Secondary objectives include measuring changes in Montreal Cognitive Assessment (MoCA) total score for global cognitive function; Hopkins Verbal Learning Test for memory; as well as dual task cost to serial subtraction performance for assessing how walking or standing affects a patient's ability to complete cognitive tasks."

Answered by AI

Is the research project currently open to new participants?

"Affirmative. Clinicaltrials.gov attests to this trial being open for recruitment, having been posted on July 8th 2019 and last modified on August 1st 2022. 120 patients need to be sourced from a single medical centre."

Answered by AI

What criteria must individuals meet in order to qualify for participation in this clinical trial?

"This medical investigation is open to 120 individuals aged between 60 and 100 who have aging. To qualify, participants must also meet specific criteria such as a score of 10 or less on the Short Physical Performance Battery, Trail Making Test (TMT) Part B time faster than 75% of age-and education-based norms, self-report mobility and balance issues, and admit having concern about falling in the future."

Answered by AI
~4 spots leftby May 2024