AgingOptiStimNCT04295798
Optimizing tDCS to Improve Dual Task Gait and Balance
A study testing Conventional tDCS and Optimized tDCS in people with Aging, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
The objective of this study is to determine the acute effects of single sessions of optimized tDCS, conventional tDCS, and sham stimulation on dual task standing and walking in older adults who are free of overt disease yet who present with poor baseline dual task performance. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Conventional tDCS and Optimized tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2020to 2 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women aged 65-85 years
- Poor dual task performance, defined as a preferred gait speed that is >10% slower when walking and simultaneously performing verbalized serial subtractions (i.e., dual tasking), as compared to walking normally (i.e. single tasking)
Who cannot join
- Unwillingness to cooperate or participate in the study protocol
- An inability to walk or stand for 30 continuous seconds without an assistive device
- A diagnosis of a gait disorder, Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, previous stroke or other neurodegenerative disorder
- Self-report of acute illness, injury or other unstable medical condition; Any report of severe lower-extremity arthritis or pain, physician-diagnosis of peripheral neuropathy, or other peripheral neuromuscular disease that may confound the effects of tDCS on gait or postural control
- Use of antipsychotics, anti-seizure, benzodiazepines, or other neuroactive medications
- Severe depression defined by a Geriatric Depression Scale score greater than 11;
- Any report or physician-diagnosis of schizophrenia, bipolar disorder or other psychiatric illness
- Contraindications to MRI or tDCS, including reported seizure within the past two years, use of neuro-active drugs, the risk of metal objects anywhere in the body, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant, pacemaker, etc.), or the presence of any active dermatological condition, such as eczema, on the scalp
Trial locations and contacts
1 site in 1 country.
United States1 site
Hebrew Rehabilitation Center
Roslindale, Massachusetts, 02131
About this study
Official title: Optimizing Transcranial Direct Current Stimulation (tDCS) to Improve Dual Task Gait and Balance in Older Adults
The objective of this study is to determine the acute effects of single sessions of optimized tDCS, conventional tDCS, and sham stimulation on dual task standing and walking in older adults who are free of overt disease yet who present with poor baseline dual task performance.
Read the detailed description
Standing and walking are almost always completed in unison with other cognitive tasks such as talking, reading or making decisions. The ability to perform this important type of "dual tasking" is critical to daily activities and dependent upon one's capacity to effectively activate appropriate brain networks that include the left dorsolateral prefrontal cortex (dlPFC). Transcranial direct current stimulation (tDCS) is a safe, noninvasive technology that can selectively modulate brain excitability (i.e., the likelihood of activation) by passing low-level currents between electrodes placed upon the scalp. We have demonstrated through a series of studies that a single, 20-minute exposure of 'conventional' tDCS targeting the left dlPFC-administered via two large sponge electrodes-reduces dual task costs to metrics of standing postural control and gait, when tested immediately following stimulation. Still, we and others have also observed relatively high between-subject variability in the effects of this conventional bipolar form of tDCS. We contend that this variability in effectiveness arises in part from relatively diffuse and unspecific current flow when using large sponge electrodes, in combination with individual variability in head and brain anatomy that significantly alters current flow and the generated electric field in the target brain region.
In this project, we will 1) apply recent advances in tDCS modeling and administration to model the electric fields generated by conventional tDCS in older adults using their individual structural brain MRIs, and 2) develop and test an multi-channel tDCS montage designed to optimize current flow to the left dlPFC (i.e., 'optimized' tDCS). Our Specific Aim is to examine the immediate after-effects of conventional tDCS, optimized tDCS, and sham stimulation on dual task standing and walking in older adults. Our study population will be older men and women without overt disease or illness, yet with poor baseline dual task performance defined as a dual task cost (i.e., reduction) to gait speed of at least 10% induced by simultaneously performing a serial subtraction task when walking. We hypothesize that across participants, the effect of conventional tDCS on dual task standing and walking performance will correlate with a specific component of the electric field generated over the left dlPFC target. We also hypothesize that optimized tDCS will induce A) greater effects on dual task standing and walking performance as compared to conventional tDCS and sham stimulation, and B) these effects will be more consistent across individuals as compared to conventional tDCS.
This project will provide important insights into tDCS "dosage" that will enable us and many other researchers to better understand, control, and optimize this form of noninvasive brain stimulation to individual head and brain anatomy. It is also expected to demonstrate that optimized tDCS, as compared to the conventional approach, significantly improves the size and consistency of observed benefits to dual task standing and walking in vulnerable older adults.
- Conditions
- Aging
- Being tested
- Conventional tDCS, Optimized tDCS, Conventional Sham, Optimized Sham
- Keywords
- Mobility, Dual Task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional tDCSDevice
The anode will be placed over F3 and the cathode over the contralateral supraorbital margin. At the beginning of stimulation, the current will be increased from 0.1 mA, in 0.1 mA increments over 60 seconds, up to a maximum of 1.8 mA. At the end of each session, current will be automatically ramped down to 0.0 mA over a 60 second period.
Optimized tDCSDevice
This intervention will utilize eight gel electrodes with placement and current parameters optimized to the cohort, with the goal of generating an average nE over the left dlPFC of the same size as the one delivered by a conventional montage using sponges. 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.
Conventional ShamDevice
Conventional sham will be used to maximize blinding of conventional sponge-based stimulation. The same sponge placement, ramp-up procedure, and session duration described above will be used; however, current will be automatically ramped down 60 seconds after ramp-up.
Optimized ShamDevice
An active sham will be used in which very low-level currents (0.5 mA max) are transferred between the same electrodes used in the active condition throughout the entire 20-minute session. This intervention will be optimized to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS. We have shown that this active sham effectively blinds participants and operators to stimulation condition and does not affect functional outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Conventional tDCS | Experimental | One 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC. Receives: Device: Conventional tDCS |
| Optimized tDCS | Experimental | One 20-minute session of active tDCS using eight gel electrodes with placement and current parameters optimized to the cohort targeting the left dlPFC. Receives: Device: Optimized tDCS |
| Conventional sham | Sham comparator | One 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session. Receives: Device: Conventional Sham |
| Optimized Sham | Sham comparator | One 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations. Receives: Device: Optimized Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in Dual Task Cost to Gait Speed From Baseline to Immediately Post Intervention
Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer, on the low back and feet to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed pre and post tDCS. Two at a preferred speed while walking quietly (single task), two at a preferred speed while performing a cognitive task (dual task) and two fast walking trials. The cognitive task during the dual task condition was verbalized serial subtractions of 3's from a random three-digit number. The absolute change was then calculated using post-intervention dual task cost minus baseline dual task cost. The outcome was calculated by averaging the dual task costs of the four trials. Negative numbers demonstrate lower (i.e., better) dual task cost post intervention. The preferred Unit of Measure is unitless.
Measured: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Dual Task Cost to Standing Postural Sway Speed From Baseline to Immediately Post Intervention
Postural sway speed was assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during six, 45-second trials of standing with eyes open (single task), eyes closed, or performing a cognitive task (dual task standing) on a stationary force platform (Kistler, Amherst, NY). The cognitive task was verbalized serial subtractions of 3's from a random three-digit number between 200 and 999. Participant responses during each trial were recorded. The absolute change was then calculated using post-intervention dual task cost minus baseline dual task cost. The outcome was obtained by averaging the dual task costs of the four trials. Negative numbers demonstrate lower (i.e., better) dual task cost post intervention. The preferred Unit of Measure is unitless.
Measured: Change from baseline to immediately post-tDCS, up to 60 minutes
Secondary outcomes (10)
Absolute Change in Dual Task Cost to Stride Time Variability From Baseline to Immediately Post Intervention
Stride time variability is a measure of how consistent limb movements are during walking and is expressed as the coefficient of variation. Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed. Two at a preferred speed while walking quietly (single task), two at a preferred speed while performing a cognitive task (dual task) and two fast walking trials. The cognitive task during the dual task condition was verbalized serial subtractions of 3's. The absolute change was then calculated using post-intervention dual task cost minus baseline dual task cost. Negative numbers demonstrate lower (i.e., better) dual task cost post intervention. The preferred Unit of Measure is unitless.
Measured: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Single Task Gait Speed From Baseline to Immediately Post Intervention
Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer, on the low back and feet to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed pre and post tDCS. Two at a preferred speed while walking quietly (single task). The absolute change from baseline to immediately post intervention was calculated by averaging the single task gait speeds (m/s) pre and post.
Measured: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Dual Task Gait Speed From Baseline to Immediately Post Intervention
Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer, on the low back and feet to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed pre and post tDCS. Two at a preferred speed while performing a cognitive task (dual task). The cognitive task during the dual task condition was verbalized serial subtractions of 3's from a random three-digit number between 200 and 999. Participant responses during each trial were recorded. The absolute change from baseline to immediately post intervention was calculated by averaging the dual task gait speeds (m/s) pre and post.
Measured: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Single Task Stride Time Variability From Baseline to Immediately Post Intervention
Stride time variability (STV) is a measure of how consistent limb movements are during walking. It's expressed as the coefficient of variation (CoV) and calculated from the mean and standard deviation of stride time. Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer, on the low back and feet to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed. Two at a preferred speed while walking quietly (single task). The absolute change from baseline to immediately post intervention was calculated by averaging the single task stride time variability pre and post.
Measured: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Dual Task Stride Time Variability From Baseline to Immediately Post Intervention
Stride time variability (STV) is a measure of how consistent limb movements are during walking. It's expressed as the coefficient of variation (CoV) and calculated from the mean and standard deviation of stride time. Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer, on the low back and feet to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed. Two at a preferred speed while performing a cognitive task (dual task). The cognitive task during the dual task condition was verbalized serial subtractions of 3's from a random three-digit number between 200 and 999. Participant responses during each trial were recorded. The absolute change from baseline to immediately post intervention was calculated by averaging the dual task stride time variability pre and post.
Measured: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Dual Task Cost to Standing Postural Sway Area From Baseline to Immediately Post Intervention
Postural sway area was assessed by measuring postural sway elliptical area during six, 45-second trials of standing with eyes open (single task), eyes closed, or performing a cognitive task (dual task standing) on a stationary force platform (Kistler, Amherst, NY). The cognitive task was verbalized serial subtractions of 3's from a random three-digit number between 200 and 999. Participant responses during each trial were recorded. The absolute change was then calculated using post-intervention dual task cost minus baseline dual task cost. The outcome was obtained by averaging the dual task costs of the four trials. Negative numbers demonstrate lower (i.e., better) dual task cost post intervention. The preferred Unit of Measure is unitless.
Measured: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Single Task Postural Sway Speed From Baseline to Immediately Post Intervention
Postural sway speed was assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during two, 45-second trials of standing with eyes open (single task) on a stationary force platform (Kistler, Amherst, NY) pre and post intervention. The absolute change from baseline to immediately post intervention was calculated by averaging the single task postural sway speed (m/s) pre and post.
Measured: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Dual Task Postural Sway Speed From Baseline to Immediately Post Intervention
Postural sway speed was assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during two, 45-second trials of standing with eyes open while performing a cognitive task (dual task) on a stationary force platform (Kistler, Amherst, NY) pre and post intervention. The cognitive task was verbalized serial subtractions of 3's from a random three-digit number between 200 and 999. Participant responses during each trial were recorded. The absolute change from baseline to immediately post intervention was calculated by averaging the dual task postural sway speed (m/s) pre and post.
Measured: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Single Task Postural Sway Area From Baseline to Immediately Post Intervention
Postural sway area was assessed by measuring postural sway elliptical area during two, 45-second trials of standing with eyes open (single task) on a stationary force platform (Kistler, Amherst, NY) pre and post intervention. The absolute change from baseline to immediately post intervention was calculated by averaging the single task postural sway area pre and post.
Measured: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Dual Task Postural Sway Area From Baseline to Immediately Post Intervention
Postural sway area was assessed by measuring postural sway elliptical area during two, 45-second trials of standing with eyes open while performing a cognitive task (dual task) on a stationary force platform (Kistler, Amherst, NY) pre and post intervention. The cognitive task was verbalized serial subtractions of 3's from a random three-digit number between 200 and 999. Participant responses during each trial were recorded. The absolute change from baseline to immediately post intervention was calculated by averaging the dual task postural sway area pre and post.
Measured: Change from baseline to immediately post-tDCS, up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start10 Feb 2020
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The investigators will conduct a "within-subject," double-blinded, randomized controlled study comparing the after-effects of single sessions of conventional tDCS, optimized tDCS, and two different sham conditions on dual task performance in men and women aged 65-85 years with poor baseline dual task performance. Participants will complete an optional structural brain MRI. They will then complete four visits during which they will receive one of the four interventions in random order.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brad Manor, Hebrew SeniorLife
- Investigators
- Brad Manor, PhD, Principal investigator, Hebrew SeniorLife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295798
- Sponsor's protocol ID
- 2019-23
- Acronym
- OptiStim
- Status last verified
- Jan 2025
- First submitted
- 2 Mar 2020
- Last updated
- 30 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Marcus Institute for Aging Research will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, physiologic, and brain imaging data, from all participants. All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Transcranial Direct Current Stimulation (tDCS) to Improve Dual Task Gait and Balance in Older Adults
- ClinicalTrials.gov ID
- NCT04295798
- Acronym / sponsor ID
- OptiStim / 2019-23
- Conditions
- Aging
- Keywords
- Mobility, Dual Task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 5 Mar 2020 (actual)
- Results
- Posted 30 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the acute effects of single sessions of optimized tDCS, conventional tDCS, and sham stimulation on dual task standing and walking in older adults who are free of overt disease yet who present with poor baseline dual task performance.
Detailed description
Standing and walking are almost always completed in unison with other cognitive tasks such as talking, reading or making decisions. The ability to perform this important type of "dual tasking" is critical to daily activities and dependent upon one's capacity to effectively activate appropriate brain networks that include the left dorsolateral prefrontal cortex (dlPFC). Transcranial direct current stimulation (tDCS) is a safe, noninvasive technology that can selectively modulate brain excitability (i.e., the likelihood of activation) by passing low-level currents between electrodes placed upon the scalp. We have demonstrated through a series of studies that a single, 20-minute exposure of 'conventional' tDCS targeting the left dlPFC-administered via two large sponge electrodes-reduces dual task costs to metrics of standing postural control and gait, when tested immediately following stimulation. Still, we and others have also observed relatively high between-subject variability in the effects of this conventional bipolar form of tDCS. We contend that this variability in effectiveness arises in part from relatively diffuse and unspecific current flow when using large sponge electrodes, in combination with individual variability in head and brain anatomy that significantly alters current flow and the generated electric field in the target brain region.
In this project, we will 1) apply recent advances in tDCS modeling and administration to model the electric fields generated by conventional tDCS in older adults using their individual structural brain MRIs, and 2) develop and test an multi-channel tDCS montage designed to optimize current flow to the left dlPFC (i.e., 'optimized' tDCS). Our Specific Aim is to examine the immediate after-effects of conventional tDCS, optimized tDCS, and sham stimulation on dual task standing and walking in older adults. Our study population will be older men and women without overt disease or illness, yet with poor baseline dual task performance defined as a dual task cost (i.e., reduction) to gait speed of at least 10% induced by simultaneously performing a serial subtraction task when walking. We hypothesize that across participants, the effect of conventional tDCS on dual task standing and walking performance will correlate with a specific component of the electric field generated over the left dlPFC target. We also hypothesize that optimized tDCS will induce A) greater effects on dual task standing and walking performance as compared to conventional tDCS and sham stimulation, and B) these effects will be more consistent across individuals as compared to conventional tDCS.
This project will provide important insights into tDCS "dosage" that will enable us and many other researchers to better understand, control, and optimize this form of noninvasive brain stimulation to individual head and brain anatomy. It is also expected to demonstrate that optimized tDCS, as compared to the conventional approach, significantly improves the size and consistency of observed benefits to dual task standing and walking in vulnerable older adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- The investigators will conduct a "within-subject," double-blinded, randomized controlled study comparing the after-effects of single sessions of conventional tDCS, optimized tDCS, and two different sham conditions on dual task performance in men and women aged 65-85 years with poor baseline dual task performance. Participants will complete an optional structural brain MRI. They will then complete four visits during which they will receive one of the four interventions in random order.
| Arm | Type | Receives |
|---|---|---|
| Conventional tDCS | Experimental | Device: Conventional tDCSOne 20-minute session of active tDCS using two 35 cm2 sponge electrodes targeting the left dlPFC. |
| Optimized tDCS | Experimental | Device: Optimized tDCSOne 20-minute session of active tDCS using eight gel electrodes with placement and current parameters optimized to the cohort targeting the left dlPFC. |
| Conventional sham | Sham comparator | Device: Conventional ShamOne 20-minute session of inactive sham tDCS delivered via two sponge electrodes for a short period of time before it is ramped down to zero for the remainder of the session. |
| Optimized Sham | Sham comparator | Device: Optimized ShamOne 20-minute session of active sham in which the Stimweaver optimization algorithm will be used with the objective of creating a null electric field on the target left dlPFC with the constraint that some gel electrodes deliver low-level currents that still induce cutaneous sensations. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Men and women aged 65-85 years
- Poor dual task performance, defined as a preferred gait speed that is >10% slower when walking and simultaneously performing verbalized serial subtractions (i.e., dual tasking), as compared to walking normally (i.e. single tasking)
Key exclusion criteria (8 listed)
- Unwillingness to cooperate or participate in the study protocol
- An inability to walk or stand for 30 continuous seconds without an assistive device
- A diagnosis of a gait disorder, Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, previous stroke or other neurodegenerative disorder
- Self-report of acute illness, injury or other unstable medical condition; Any report of severe lower-extremity arthritis or pain, physician-diagnosis of peripheral neuropathy, or other peripheral neuromuscular disease that may confound the effects of tDCS on gait or postural control
- Use of antipsychotics, anti-seizure, benzodiazepines, or other neuroactive medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional tDCSThe anode will be placed over F3 and the cathode over the contralateral supraorbital margin. At the beginning of stimulation, the current will be increased from 0.1 mA, in 0.1 mA increments over 60 seconds, up to a maximum of 1.8 mA. At the end of each session, current will be automatically ramped down to 0.0 mA over a 60 second period. | Device | Conventional tDCS |
| Optimized tDCSThis intervention will utilize eight gel electrodes with placement and current parameters optimized to the cohort, with the goal of generating an average nE over the left dlPFC of the same size as the one delivered by a conventional montage using sponges. 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. | Device | Optimized tDCS |
| Conventional ShamConventional sham will be used to maximize blinding of conventional sponge-based stimulation. The same sponge placement, ramp-up procedure, and session duration described above will be used; however, current will be automatically ramped down 60 seconds after ramp-up. | Device | Conventional sham |
| Optimized ShamAn active sham will be used in which very low-level currents (0.5 mA max) are transferred between the same electrodes used in the active condition throughout the entire 20-minute session. This intervention will be optimized to deliver currents designed to not significantly influence their cortical tissue, but still mimic the cutaneous sensations induced by tDCS. We have shown that this active sham effectively blinds participants and operators to stimulation condition and does not affect functional outcomes. | Device | Optimized Sham |
Primary outcome
Absolute Change in Dual Task Cost to Gait Speed From Baseline to Immediately Post Intervention
Time frame: Change from baseline to immediately post-tDCS, up to 60 minutes
Prior to testing, participants were outfitted with wireless biosensors, each containing a triaxial accelerometer, goniometer and magnetometer, on the low back and feet to record gait kinematics (Mobility Lab™, APDM Inc). Six 25-meter walking trials were completed pre and post tDCS. Two at a preferred speed while walking quietly (single task), two at a preferred speed while performing a cognitive task (dual task) and two fast walking trials. The cognitive task during the dual task condition was verbalized serial subtractions of 3's from a random three-digit number. The absolute change was then calculated using post-intervention dual task cost minus baseline dual task cost. The outcome was calculated by averaging the dual task costs of the four trials. Negative numbers demonstrate lower (i.e., better) dual task cost post intervention. The preferred Unit of Measure is unitless.
Absolute Change in Dual Task Cost to Standing Postural Sway Speed From Baseline to Immediately Post Intervention
Time frame: Change from baseline to immediately post-tDCS, up to 60 minutes
Postural sway speed was assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during six, 45-second trials of standing with eyes open (single task), eyes closed, or performing a cognitive task (dual task standing) on a stationary force platform (Kistler, Amherst, NY). The cognitive task was verbalized serial subtractions of 3's from a random three-digit number between 200 and 999. Participant responses during each trial were recorded. The absolute change was then calculated using post-intervention dual task cost minus baseline dual task cost. The outcome was obtained by averaging the dual task costs of the four trials. Negative numbers demonstrate lower (i.e., better) dual task cost post intervention. The preferred Unit of Measure is unitless.
10 secondary outcomes
Absolute Change in Dual Task Cost to Stride Time Variability From Baseline to Immediately Post Intervention
Time frame: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Single Task Gait Speed From Baseline to Immediately Post Intervention
Time frame: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Dual Task Gait Speed From Baseline to Immediately Post Intervention
Time frame: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Single Task Stride Time Variability From Baseline to Immediately Post Intervention
Time frame: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Dual Task Stride Time Variability From Baseline to Immediately Post Intervention
Time frame: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Dual Task Cost to Standing Postural Sway Area From Baseline to Immediately Post Intervention
Time frame: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Single Task Postural Sway Speed From Baseline to Immediately Post Intervention
Time frame: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Dual Task Postural Sway Speed From Baseline to Immediately Post Intervention
Time frame: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Single Task Postural Sway Area From Baseline to Immediately Post Intervention
Time frame: Change from baseline to immediately post-tDCS, up to 60 minutes
Absolute Change in Dual Task Postural Sway Area From Baseline to Immediately Post Intervention
Time frame: Change from baseline to immediately post-tDCS, up to 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The Marcus Institute for Aging Research will promote the development of new research and new investigators by making the data available to outside investigators. The database will include longitudinal demographic, clinical, functional, physiologic, and brain imaging data, from all participants. All data will be stripped of primary identifiers and entered into a master database. All data collection procedures, variable definitions and codes, field locations, and frequencies will be documented in a separate file.
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Aging
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad Manor, PhD principal investigator
Hebrew SeniorLife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional tDCS and Optimized tDCS in people with Aging, run by Hebrew SeniorLife at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change in Dual Task Cost to Gait Speed From Baseline to Immediately Post Intervention (time frame: Change from baseline to immediately post-tDCS, up to 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.