AgingNCT03191812
The Short-term Effects of Noninvasive Electrical Brain Stimulation on Dual Tasking in Older Adults
A study testing transcranial Direct Current Stimulation (tDCS) in people with Aging, run by Hebrew SeniorLife at 2 sites in 2 countries.
Trial summary
The tDCS \& Dual Tasking study will compare the effects of transcranial Direct Current Stimulation (tDCS) targeting three different cortical regions (as well as sham stimulation) on dual task standing and walking in older adults with and without a recent history of recurrent falls. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- transcranial Direct Current Stimulation (tDCS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 26 May 2017to 26 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- "Faller" group
- Aged 65 years and older
- Able to read, write and communicate in English
- Self-report of 2 or more falls within the past 6 months
- "Non-Faller" Group
- Aged 65 years and older
- Able to read, write, and communicate in English
- Self-report of 1 or no (zero) falls within the past 6 months
Who cannot join
- Self-reported diagnosis of Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, history of stroke or other neurodegenerative disorder.
- Self-reported active cancer for which chemo-/radiation therapy is being received.
- Hospitalization within the past 3 months due to acute illness or as a result of a musculoskeletal injury significantly affecting gait and balance.
- Montreal Cognitive Assessment score <18, or insufficient understanding of study procedures following review of the Informed Consent Form. Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
- Inability to stand or ambulate unassisted for at least 25 feet.
- Contraindications to tDCS, including a reported seizure within the past two years, use of neuro-active drugs, the risk of metal objects in the brain, skull, or head, self-reported presence of specific implanted medical devices (e.g., deep brain stimulator, medication infusion pump, cochlear implant), or the presence of any active dermatological condition, such as eczema, on the scalp (see appendix for standardized tDCS screening questionnaire).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Hebrew Rehabilitation Center
Roslindale, Massachusetts, 02131
Israel1 site
Laboratory for Gait and Neurodynamics, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
About this study
Official title: Optimization of Transcranial Direct Current Stimulation (tDCS) for Dual Task Performance in Older Adults With and Without a History of Falls
The tDCS \& Dual Tasking study will compare the effects of transcranial Direct Current Stimulation (tDCS) targeting three different cortical regions (as well as sham stimulation) on dual task standing and walking in older adults with and without a recent history of recurrent falls.
Read the detailed description
The ability to stand and walk safely, especially while performing additional cognitive tasks like talking, reading or decision making, is critical to the preservation of functional independence into old age. Such "dual tasking" often impairs balance, even in healthy older adults and those with greater dual task "costs" are more likely to suffer future falls. Transcranial direct current stimulation (tDCS) is a safe, noninvasive and inexpensive means of modulating activity across cortical networks. A single, 20-minute session of tDCS facilitates brain activity for up to 24 hours. Through Dr. Manor's previous research in healthy older adults, he has discovered that just 20 minutes of tDCS targeting the left dorsolateral prefrontal cortex (dlPFC)-a region involved in both cognitive and motor function-immediately reduces the dual task costs to balance when standing and walking, and improves performance in the timed up-and-go (TUG) test of mobility. However, there are several brain networks with known involvement in balance control and dual tasking, and the optimal brain region to target to improve dual task capacity has not been established. The proposed study will be a double-blinded, sham-controlled study in which older adults both with and without a history of falling undergo dual task assessments immediately before and after single, 20-minute sessions of tDCS designed to target several different brain regions with known involvement in dual tasking and the maintenance of balance.
- Conditions
- Aging
- Being tested
- transcranial Direct Current Stimulation (tDCS)
- Keywords
- Falls, transcranial Direct Current Stimulation, Mobility, Dual Task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Direct Current Stimulation (tDCS)Other
There will be three different tDCS targets as well as a sham stimulation condition. The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
| Study group | Role | What they receive |
|---|---|---|
| Sham Stimulation | Sham comparator | The Sham stimulation intervention will consist of one, twenty-minute session of transcranial direct current stimulation (tDCS) that does not target a cortical area but instead, provides just enough current to create tingling sensations across the scalp to mimic the feeling of receiving the real stimulation. The sham stimulation will use the same number and placement of electrodes as the real stimulation but with a much smaller total current intensity of 0.5 milliamps (mA). Receives: Other: transcranial Direct Current Stimulation (tDCS) |
| M1 Stimulation | Experimental | The M1 stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the primary motor cortex at a total current intensity of 1.5 mA. Receives: Other: transcranial Direct Current Stimulation (tDCS) |
| DLPFC Stimulation | Experimental | The DLPFC stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex at a total current intensity of 1.5 mA. Receives: Other: transcranial Direct Current Stimulation (tDCS) |
| M1+DLPFC Stimulation | Experimental | The M1+DLPFC stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the primary motor cortex and the dorsolateral prefrontal cortex simultaneously at a total current intensity of 3.0 mA. Receives: Other: transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual task cost to standing postural sway speed
The dual task cost to standing postural sway speed will be calculated from trials of standing with and without simultaneous performance of a serial subtraction cognitive task. The dual task cost will be calculated as the percent change in sway speed from single- to dual-task conditions.
Measured: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Dual task cost to gait speed when walking
The dual task cost to gait speed when walking will be calculated from trials of walking with and without simultaneous performance of a serial subtraction cognitive task. The dual task cost will be calculated as the percent change in gait speed from single- to dual-task conditions.
Measured: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Secondary outcomes (10)
Dual task cost to postural sway area
The dual task cost to standing postural sway area will be calculated from trials of standing with and without simultaneous performance of a serial subtraction cognitive task. The dual task cost will be calculated as the percent change in postural sway area from single- to dual-task conditions.
Measured: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Dual task cost to gait variability when walking
The dual task cost to gait variability when walking will be calculated from trials of walking with and without simultaneous performance of a serial subtraction cognitive task. Gait variability will be defined as the coefficient of variation about the average stride time (stride times defined by the time between consecutive heel strides of the same leg). The dual task cost will be calculated as the percent change in gait variability from single- to dual-task conditions.
Measured: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Single task postural sway speed
Single task postural sway speed will be calculated from trials of standing without simultaneous performance of a serial subtraction cognitive task.
Measured: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Single task postural sway area
Single task postural sway area will be calculated from trials of standing without simultaneous performance of a serial subtraction cognitive task.
Measured: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Single task gait speed variability when walking
Single task gait variability when walking will be calculated from trials of walking without simultaneous performance of a serial subtraction cognitive task. Gait variability will be defined as the coefficient of variation about the average stride time (stride times defined by the time between consecutive heel strides of the same leg).
Measured: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Single task gait speed when walking
Single task gait speed when walking will be calculated from trials of walking without simultaneous performance of a serial subtraction cognitive task.
Measured: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Mobility
Mobility will be assessed using the Timed Up-and-Go test in which the amount of time it takes for the participant to stand up from a chair, walk three meters, turn around a cone, walk back, and sit down is recorded.
Measured: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Executive function
Executive function will be assessed using the Stroop test.
Measured: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Cognitive processing speed
Cognitive processing speed will be assessed using the Symbol Digit Modalities Test (SDMT).
Measured: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Attention
Attention will be assessed using the Visual Search and Attention Test (VSAT).
Measured: This outcome will be assessed immediately before and after each 20-minute session of tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start26 May 2017
- Primary completion26 Nov 2019
- Study completion26 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 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, Principal investigator, Institute for Aging Research, Hebrew SeniorLife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191812
- Sponsor's protocol ID
- 2016-26
- Status last verified
- Mar 2022
- First submitted
- 15 Jun 2017
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Transcranial Direct Current Stimulation (tDCS) for Dual Task Performance in Older Adults With and Without a History of Falls
- ClinicalTrials.gov ID
- NCT03191812
- Acronym / sponsor ID
- 2016-26
- Conditions
- Aging
- Keywords
- Falls, transcranial Direct Current Stimulation, Mobility, Dual Task
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Study start
- 26 May 2017 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The tDCS \& Dual Tasking study will compare the effects of transcranial Direct Current Stimulation (tDCS) targeting three different cortical regions (as well as sham stimulation) on dual task standing and walking in older adults with and without a recent history of recurrent falls.
Detailed description
The ability to stand and walk safely, especially while performing additional cognitive tasks like talking, reading or decision making, is critical to the preservation of functional independence into old age. Such "dual tasking" often impairs balance, even in healthy older adults and those with greater dual task "costs" are more likely to suffer future falls. Transcranial direct current stimulation (tDCS) is a safe, noninvasive and inexpensive means of modulating activity across cortical networks. A single, 20-minute session of tDCS facilitates brain activity for up to 24 hours. Through Dr. Manor's previous research in healthy older adults, he has discovered that just 20 minutes of tDCS targeting the left dorsolateral prefrontal cortex (dlPFC)-a region involved in both cognitive and motor function-immediately reduces the dual task costs to balance when standing and walking, and improves performance in the timed up-and-go (TUG) test of mobility. However, there are several brain networks with known involvement in balance control and dual tasking, and the optimal brain region to target to improve dual task capacity has not been established. The proposed study will be a double-blinded, sham-controlled study in which older adults both with and without a history of falling undergo dual task assessments immediately before and after single, 20-minute sessions of tDCS designed to target several different brain regions with known involvement in dual tasking and the maintenance of balance.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham Stimulation | Sham comparator | Other: transcranial Direct Current Stimulation (tDCS)The Sham stimulation intervention will consist of one, twenty-minute session of transcranial direct current stimulation (tDCS) that does not target a cortical area but instead, provides just enough current to create tingling sensations across the scalp to mimic the feeling of receiving the real stimulation. The sham stimulation will use the same number and placement of electrodes as the real stimulation but with a much smaller total current intensity of 0.5 milliamps (mA). |
| M1 Stimulation | Experimental | Other: transcranial Direct Current Stimulation (tDCS)The M1 stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the primary motor cortex at a total current intensity of 1.5 mA. |
| DLPFC Stimulation | Experimental | Other: transcranial Direct Current Stimulation (tDCS)The DLPFC stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the dorsolateral prefrontal cortex at a total current intensity of 1.5 mA. |
| M1+DLPFC Stimulation | Experimental | Other: transcranial Direct Current Stimulation (tDCS)The M1+DLPFC stimulation intervention consists of one, twenty-minute session of transcranial direct current stimulation (tDCS) targeting the primary motor cortex and the dorsolateral prefrontal cortex simultaneously at a total current intensity of 3.0 mA. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- "Faller" group
- Aged 65 years and older
- Able to read, write and communicate in English
- Self-report of 2 or more falls within the past 6 months
- "Non-Faller" Group
Key exclusion criteria (6 listed)
- Self-reported diagnosis of Parkinson's disease, Alzheimer's disease or dementia, multiple sclerosis, history of stroke or other neurodegenerative disorder.
- Self-reported active cancer for which chemo-/radiation therapy is being received.
- Hospitalization within the past 3 months due to acute illness or as a result of a musculoskeletal injury significantly affecting gait and balance.
- Montreal Cognitive Assessment score <18, or insufficient understanding of study procedures following review of the Informed Consent Form. Understanding will be assessed by asking the participant to answer the following three questions: 1) What is the purpose of this study? 2) What are the risks of study involvement? 3) If you decide to participate, are you allowed to withdraw from the study at any time? Answers will be recorded by study personnel on the "Assessment of Protocol Understanding" form (see attached). Insufficient understanding will be defined by one or more incorrect answers, as determined at the discretion of the investigator.
- Inability to stand or ambulate unassisted for at least 25 feet.
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 |
|---|---|---|
| transcranial Direct Current Stimulation (tDCS)There will be three different tDCS targets as well as a sham stimulation condition. The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes. | Other | DLPFC Stimulation, M1 Stimulation, M1+DLPFC Stimulation, Sham Stimulation |
Primary outcome
Dual task cost to standing postural sway speed
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
The dual task cost to standing postural sway speed will be calculated from trials of standing with and without simultaneous performance of a serial subtraction cognitive task. The dual task cost will be calculated as the percent change in sway speed from single- to dual-task conditions.
Dual task cost to gait speed when walking
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
The dual task cost to gait speed when walking will be calculated from trials of walking with and without simultaneous performance of a serial subtraction cognitive task. The dual task cost will be calculated as the percent change in gait speed from single- to dual-task conditions.
10 secondary outcomes
Dual task cost to postural sway area
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Dual task cost to gait variability when walking
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Single task postural sway speed
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Single task postural sway area
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Single task gait speed variability when walking
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Single task gait speed when walking
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Mobility
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Executive function
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Cognitive processing speed
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.
Attention
Time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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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 principal investigator
Institute for Aging Research, Hebrew SeniorLife
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Direct Current Stimulation (tDCS) in people with Aging, run by Hebrew SeniorLife at 2 sites in 2 countries.
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 8 inclusion and 6 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 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dual task cost to standing postural sway speed (time frame: This outcome will be assessed immediately before and after each 20-minute session of tDCS.). 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 15 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.