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Non-invasive Brain Stimulation

Traditional tDCS for Aging (OptiStim Trial)

N/A
Waitlist Available
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
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to immediate post-tdcs follow-up
Awards & highlights

OptiStim Trial Summary

This trial looks at whether electrical stimulation can help improve balance and walking in older adults who have no major health problems but have poor coordination.

OptiStim Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to immediate post-tdcs follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to immediate post-tdcs 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
Dual task cost to gait speed
Dual task cost to postural sway speed
Secondary outcome measures
Dual task cost to postural sway area
Dual task cost to stride time variability
Dual task gait speed
+7 more

OptiStim Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Traditional tDCSExperimental Treatment1 Intervention
At the beginning of stimulation, the current will be increased manually from 0.1 mA, in 0.1 mA increments over 60 seconds, up to a maximum of 1.8 mA. Participants will be instructed to notify study personnel if and when they feel any uncomfortable sensation. The ramp-up will be stopped at this point and for the remainder of the session tDCS will be delivered at an intensity of 0.1 mA below the highest level reached. At the end of each session, current will be automatically ramped down to 0.0 mA over a 60 second period.
Group II: Personalized tDCSExperimental Treatment1 Intervention
Baseline MRI's will enable personalization of tDCS via current flow modeling and optimized to each participant with the goal of generating an average nE over the dlPFC of the same size as the one delivered by a traditional montage using sponges in an average subject at 1.5 mA of current. The direct current delivered by any one electrode will however never 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 III: Traditional ShamPlacebo Group1 Intervention
A traditional sham will be used to maximize blinding of traditional sponge-based stimulation. The same sponge placement, ramp-up procedure, and session duration as described with the Traditional tDCS will be used; however, current will automatically be ramped down 60 seconds after ramp-up.
Group IV: Personalized ShamPlacebo Group1 Intervention
An active sham will be used in which very low-level currents (0.5mA max) are transferred between the same electrodes used in the active condition 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.

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Who is running the clinical trial?

Hebrew SeniorLifeLead Sponsor
46 Previous Clinical Trials
270,716 Total Patients Enrolled
15 Trials studying Aging
4,062 Patients Enrolled for Aging
Brad Manor, PhDPrincipal Investigator - Hebrew SeniorLife
Hebrew SeniorLife
5 Previous Clinical Trials
394 Total Patients Enrolled
4 Trials studying Aging
250 Patients Enrolled for Aging
~6 spots leftby Jun 2025