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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to immediate post-tdcs follow-up

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

45 Previous Clinical Trials

270,523 Total Patients Enrolled

14 Trials studying Aging

3,843 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

Frequently Asked Questions

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

What goals are researchers hoping to achieve through this clinical trial?

"This trial will focus on the primary outcome of dual task cost to postural sway speed, as well as three secondary objectives: single task gait speed, dual task postural sway area and single task stride time variability. Data collection for these metrics spans from baseline to immediate post-tdcs follow-up."

Answered by AI

Who has the opportunity to participate in this medical research?

"This medical trial is accepting 30 seniors aged 65-85 who demonstrate signs of aging. To qualify, male and female applicants must display a 20% decrease in gait speed when performing dual tasks such as verbalized serial subtractions while walking compared to single tasking."

Answered by AI

Is enrollment for this experiment still open?

"Per clinicaltrials.gov, this medical experimentation is currently open for participants. The trial was initially launched on February 10th of 2020 and has seen its last update on October 24th of 2022."

Answered by AI

What is the aggregate amount of participants actively engaged in this trial?

"Confirmed. Clinicaltrials.gov data reveals that this study commenced recruiting on February 10th 2020 and is still actively doing so, according to the last update from October 24th 2022. The research team seeks 30 participants at a single site for their trial."

Answered by AI

Is the age limitation for this research study greater than sixty years?

"The inclusion criteria of this medical trial states that patients over 65 and under 85 years old are eligible to apply. Of the 240 trials, only one is suitable for those below 18 while 239 are exclusively open to elderly individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimizing tDCS to Improve Dual Task Gait and Balance

Brad Manor 2020. "Optimizing tDCS to Improve Dual Task Gait and Balance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04295798.