AgingBrainSTIMNCT02436915
The Effects of Noninvasive Brain Stimulation on Physical and Mental Functioning in Older Adults
A study testing Real 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 whether augmentation of prefrontal brain excitability using noninvasive transcranial direct current stimulation (tDCS) lessens the severity of the symptom triad associated with cerebral microvascular disease (CMD); that is, slow gait, cognitive dysfunction and depressive… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Real tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Slow gait, defined by an over-ground preferred walking speed of less than or equal to 1.0 m/s.
- Executive dysfunction, defined by a Trail Making Test B z-score of greater than one standard deviation below age- and gender-based norms.
Who cannot join
- Non-ambulatory
- Clinical history or brain imaging evidence of a previous stroke
- Parkinson's Disease
- Normal pressure hydrocephalus
- Other neurodegenerative condition
- Severe depression
Show all 9Show fewer
- Lower-extremity arthritis or pain causing slow gait
- Inability or unwillingness to understand or participate in the study protocol
- Contraindications to MRI or tDCS, including (but not limited to) personal or family history of epilepsy, use of neuro-active drugs, claustrophobia or risk of metal objects in the body.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hebrew Rehabilitation Center
Roslindale, Massachusetts, 02131
About this study
The objective of this study is to determine whether augmentation of prefrontal brain excitability using noninvasive transcranial direct current stimulation (tDCS) lessens the severity of the symptom triad associated with cerebral microvascular disease (CMD); that is, slow gait, cognitive dysfunction and depressive symptoms. Investigators will complete this objective by conducting a pilot, double-blinded randomized controlled trial of a 10-day intervention of real versus sham tDCS in 40 subjects.
Read the detailed description
Biological aging, especially when coupled with cardiovascular risk factors, leads to chronic endothelial dysfunction within cerebral micro-vessels that impairs the brain's ability to meet the metabolic demands placed upon it by everyday life. This chronic mismatch between blood supply and metabolic demand often leads to cerebral microvascular disease (CMD), or the accumulation of ischemic damage within a network of frontal and subcortical regions. CMD is recognized as white matter hyperintensities on MRI scans and manifests clinically as mobility impairment, executive dysfunction and depressed affect. As 11-17% of elderly individuals present with this constellation of symptoms, and each of these symptoms is independently linked to increased morbidity and mortality, CMD is a critical yet understudied healthcare issue with rapidly-growing personal and economic costs.
There is currently no cure for CMD and trials aimed at pharmacological improvement of nonselective systemic vasodilation report no therapeutic value (Sorrond \& Lipsitz, 2011). Our team, however, has demonstrated that the severity of clinical symptoms suffered by those with CMD is critically dependent upon the brain's remaining capacity to activate the appropriate cortical networks when metabolic demand is increased by the performance of various cognitive-motor tasks (Purkayastha et al., 2014; Sorond et al., 2010; Sorond et al., 2011). Therefore, investigators predict that improvement in the capacity to activate the appropriate cortical networks in response to increased metabolic demand would ameliorate the symptoms and improve the quality of life of patients with CMD.
Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability. One 20-minute session of tDCS targeting the left prefrontal cortex acutely increases cortical activation during both cognitive and motor task performance in healthy adults. Investigators have demonstrated that this same stimulation improves mobility and cognitive performance in community-dwelling older adults. Moreover, repeated tDCS sessions over a one month period reduce symptoms of depression and may improve executive function in healthy individuals. This preliminary evidence suggests that tDCS may be an effective intervention for CMD; however, the impact of tDCS on this disease has not been investigated.
The study investigators ultimately aim to investigate the therapeutic efficacy of tDCS in patients with CMD by conducting a double-blind, proof-of-principle, sham-controlled trail along with extensive functional and neurophysiological assessments. In order to finalize the design and plan the implementation of this definitive trial, investigators currently aim to:
- Conduct a pilot study to establish the feasibility of deployment of tDCS in large populations of individuals with CMD, and to obtain preliminary evidence for a causal effect of the intervention on mobility, executive function and depressive symptoms in this population.
- Within the pilot study, investigate the effects of the tDCS intervention on cortical activation in response to cognitive-motor tasks.
This study will provide first-of-its-kind, proof-of-principle evidence on whether tDCS provides meaningful symptomatic relief to patients with CMD. Moreover, it will inform a more definitive, larger-scale randomized controlled trial (RCT) by providing information on recruitment and retention, compliance, estimates of effect size, and the neurophysiological underpinnings of expected functional improvements. If successful, knowledge gained is also expected to spur the investigation of tDCS as treatment for many other diseases-from dementia to diabetes-that negatively impact the brain's capacity to activate appropriate cortical networks.
- Conditions
- Aging
- Being tested
- Real tDCS, Sham tDCS
- Keywords
- Slow gait, Executive function, Transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real tDCSOther
Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
Sham tDCSOther
For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS | Experimental | The "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) targeting left prefrontal cortex at a target current intensity of 1.5 mA. Receives: Other: Real tDCS |
| Sham tDCS | Sham comparator | The "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation with same montage as the "real tDCS", except current will only be applied for the first 60 seconds of each session. Receives: Other: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to Post Intervention on Mobility
Mobility and turning will be assessed by the timed up-and-go test (TUG) (Podsiadlo \& Richardson, 1991). The participant will be seated in an armed chair. On the word "go," the subject will stand up using the arm rests if needed, walk (with assistive device if needed) around a cone placed three meters in front of the chair, return and sit down as quickly as possible. Time to complete the TUG test will be used as the outcome measure.
Measured: baseline, immediately after intervention and 2 weeks post intervention
Percent Change From Baseline to Post Intervention on Global Cognition Impairment
The Montreal Cognitive Assessment (MoCA) score is used as the outcome measure of Global Cognition Impairment. MoCA score ranges from 0 to 30. Lower MoCA score represents poorer cognitive function (i.e., more severe Global Cognition Impairment).
Measured: Baseline, immediately after intervention and 2 weeks post intervention
Percent Change From Baseline to Post Intervention on Dual Task Cost to Walking Speed in 24-meter Walking Test
Six 24-meter walking trials at a preferred speed are completed and each three of them are in normal or dual task condition. The GaitRite pressure mat (Havertown, PA) will be used to record bilateral foot placements and measure the walking speed. Dual task cost to walking speed is defined as the percent change of walking speed from normal walking to dual task walking. The outcome was calculated by averaging the dual task costs of the six trials.
Measured: baseline, immediately after intervention and 2 weeks post intervention
Percent Change From Baseline to Post Intervention on Dual Task Cost to Standing Postural Sway Speed
Postural sway speed - assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during six, 30-second trials of standing with eyes open (single task) or performing a cognitive task (dual task standing) on a stationary force platform (Kistler, Amherst, NY). Dual task cost is defined as the percent change of sway speed from single task standing to dual task standing. The outcome was obtained by averaging the dual task costs of the six trials.
Measured: baseline, immediately after intervention and 2 weeks post intervention
Secondary outcomes (4)
Percent Change From Baseline to Post Intervention on Geriatric Depression Scale (GDS) Score
GDS total Score. The GDS total score ranges from 0 to 15. Higher GDS score represents more severe depression.
Measured: baseline, immediately after intervention and 2 weeks post intervention
Percent Change From Baseline to Post Intervention on Trial Making Test (TMT)
Time to complete Trail Making Test part B minus time to complete TMT part A. Slower time to complete TMT-B as compared to TMT-A represents poorer executive function.
Measured: baseline, immediately after intervention and 2 weeks post intervention
Percent Change From Baseline to Post Intervention on Dual-task Cost to Standing Sway Area
Postural sway speed - assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during six, 30-second trials of standing with eyes open (single task) or performing a cognitive task (dual task standing) on a stationary force platform (Kistler, Amherst, NY). Dual task cost is defined as the percent change of sway area from single task standing to dual task standing. The outcome was calculated by averaging the dual task costs of the six trials.
Measured: baseline, immediately after intervention and 2 weeks post intervention
Percent Change From Baseline to Post Intervention on Dual Task Cost to Stride Time in 24-meter Walking Test
Six 24-meter walking trials at a preferred speed are completed and each three of them are in normal or dual task condition. The GaitRite pressure mat (Havertown, PA) will be used to record bilateral foot placements and measure the walking speed. Dual task cost to stride time is defined as the percent change of stride time from normal walking to dual task walking.The outcome was calculated by averaging the dual task costs of the six trials.
Measured: baseline, immediately after intervention and 2 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2016
- Study completionDec 2016
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, The Falk Medical Research Trust, Bank of America, N.A. Trustee
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436915
- Sponsor's protocol ID
- 15-002
- Acronym
- BrainSTIM
- Status last verified
- Jan 2018
- First submitted
- 10 Apr 2015
- Last updated
- 5 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Noninvasive Brain Stimulation on Physical and Mental Functioning in Older Adults
- ClinicalTrials.gov ID
- NCT02436915
- Acronym / sponsor ID
- BrainSTIM / 15-002
- Conditions
- Aging
- Keywords
- Slow gait, Executive function, Transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, The Falk Medical Research Trust, Bank of America, N.A. Trustee
- Study start
- Jun 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 7 May 2015 (estimated)
- Results
- Posted 5 Jun 2019
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 whether augmentation of prefrontal brain excitability using noninvasive transcranial direct current stimulation (tDCS) lessens the severity of the symptom triad associated with cerebral microvascular disease (CMD); that is, slow gait, cognitive dysfunction and depressive symptoms. Investigators will complete this objective by conducting a pilot, double-blinded randomized controlled trial of a 10-day intervention of real versus sham tDCS in 40 subjects.
Detailed description
Biological aging, especially when coupled with cardiovascular risk factors, leads to chronic endothelial dysfunction within cerebral micro-vessels that impairs the brain's ability to meet the metabolic demands placed upon it by everyday life. This chronic mismatch between blood supply and metabolic demand often leads to cerebral microvascular disease (CMD), or the accumulation of ischemic damage within a network of frontal and subcortical regions. CMD is recognized as white matter hyperintensities on MRI scans and manifests clinically as mobility impairment, executive dysfunction and depressed affect. As 11-17% of elderly individuals present with this constellation of symptoms, and each of these symptoms is independently linked to increased morbidity and mortality, CMD is a critical yet understudied healthcare issue with rapidly-growing personal and economic costs.
There is currently no cure for CMD and trials aimed at pharmacological improvement of nonselective systemic vasodilation report no therapeutic value (Sorrond \& Lipsitz, 2011). Our team, however, has demonstrated that the severity of clinical symptoms suffered by those with CMD is critically dependent upon the brain's remaining capacity to activate the appropriate cortical networks when metabolic demand is increased by the performance of various cognitive-motor tasks (Purkayastha et al., 2014; Sorond et al., 2010; Sorond et al., 2011). Therefore, investigators predict that improvement in the capacity to activate the appropriate cortical networks in response to increased metabolic demand would ameliorate the symptoms and improve the quality of life of patients with CMD.
Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability. One 20-minute session of tDCS targeting the left prefrontal cortex acutely increases cortical activation during both cognitive and motor task performance in healthy adults. Investigators have demonstrated that this same stimulation improves mobility and cognitive performance in community-dwelling older adults. Moreover, repeated tDCS sessions over a one month period reduce symptoms of depression and may improve executive function in healthy individuals. This preliminary evidence suggests that tDCS may be an effective intervention for CMD; however, the impact of tDCS on this disease has not been investigated.
The study investigators ultimately aim to investigate the therapeutic efficacy of tDCS in patients with CMD by conducting a double-blind, proof-of-principle, sham-controlled trail along with extensive functional and neurophysiological assessments. In order to finalize the design and plan the implementation of this definitive trial, investigators currently aim to:
- Conduct a pilot study to establish the feasibility of deployment of tDCS in large populations of individuals with CMD, and to obtain preliminary evidence for a causal effect of the intervention on mobility, executive function and depressive symptoms in this population.
- Within the pilot study, investigate the effects of the tDCS intervention on cortical activation in response to cognitive-motor tasks.
This study will provide first-of-its-kind, proof-of-principle evidence on whether tDCS provides meaningful symptomatic relief to patients with CMD. Moreover, it will inform a more definitive, larger-scale randomized controlled trial (RCT) by providing information on recruitment and retention, compliance, estimates of effect size, and the neurophysiological underpinnings of expected functional improvements. If successful, knowledge gained is also expected to spur the investigation of tDCS as treatment for many other diseases-from dementia to diabetes-that negatively impact the brain's capacity to activate appropriate cortical networks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real tDCS | Experimental | Other: Real tDCSThe "real tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation (tDCS) targeting left prefrontal cortex at a target current intensity of 1.5 mA. |
| Sham tDCS | Sham comparator | Other: Sham tDCSThe "sham tDCS" intervention will consist of 10 daily 20-minute sessions of transcranial direct current stimulation with same montage as the "real tDCS", except current will only be applied for the first 60 seconds of each session. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Slow gait, defined by an over-ground preferred walking speed of less than or equal to 1.0 m/s.
- Executive dysfunction, defined by a Trail Making Test B z-score of greater than one standard deviation below age- and gender-based norms.
Key exclusion criteria (9 listed)
- Non-ambulatory
- Clinical history or brain imaging evidence of a previous stroke
- Parkinson's Disease
- Normal pressure hydrocephalus
- Other neurodegenerative condition
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 |
|---|---|---|
| Real tDCSTranscranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability. | Other | Real tDCS |
| Sham tDCSFor sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation. | Other | Sham tDCS |
Primary outcome
Percent Change From Baseline to Post Intervention on Mobility
Time frame: baseline, immediately after intervention and 2 weeks post intervention
Mobility and turning will be assessed by the timed up-and-go test (TUG) (Podsiadlo \& Richardson, 1991). The participant will be seated in an armed chair. On the word "go," the subject will stand up using the arm rests if needed, walk (with assistive device if needed) around a cone placed three meters in front of the chair, return and sit down as quickly as possible. Time to complete the TUG test will be used as the outcome measure.
Percent Change From Baseline to Post Intervention on Global Cognition Impairment
Time frame: Baseline, immediately after intervention and 2 weeks post intervention
The Montreal Cognitive Assessment (MoCA) score is used as the outcome measure of Global Cognition Impairment. MoCA score ranges from 0 to 30. Lower MoCA score represents poorer cognitive function (i.e., more severe Global Cognition Impairment).
Percent Change From Baseline to Post Intervention on Dual Task Cost to Walking Speed in 24-meter Walking Test
Time frame: baseline, immediately after intervention and 2 weeks post intervention
Six 24-meter walking trials at a preferred speed are completed and each three of them are in normal or dual task condition. The GaitRite pressure mat (Havertown, PA) will be used to record bilateral foot placements and measure the walking speed. Dual task cost to walking speed is defined as the percent change of walking speed from normal walking to dual task walking. The outcome was calculated by averaging the dual task costs of the six trials.
Percent Change From Baseline to Post Intervention on Dual Task Cost to Standing Postural Sway Speed
Time frame: baseline, immediately after intervention and 2 weeks post intervention
Postural sway speed - assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during six, 30-second trials of standing with eyes open (single task) or performing a cognitive task (dual task standing) on a stationary force platform (Kistler, Amherst, NY). Dual task cost is defined as the percent change of sway speed from single task standing to dual task standing. The outcome was obtained by averaging the dual task costs of the six trials.
4 secondary outcomes
Percent Change From Baseline to Post Intervention on Geriatric Depression Scale (GDS) Score
Time frame: baseline, immediately after intervention and 2 weeks post intervention
Percent Change From Baseline to Post Intervention on Trial Making Test (TMT)
Time frame: baseline, immediately after intervention and 2 weeks post intervention
Percent Change From Baseline to Post Intervention on Dual-task Cost to Standing Sway Area
Time frame: baseline, immediately after intervention and 2 weeks post intervention
Percent Change From Baseline to Post Intervention on Dual Task Cost to Stride Time in 24-meter Walking Test
Time frame: baseline, immediately after intervention and 2 weeks post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real 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 9 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 5 Jun 2019. 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 5 Jun 2019). 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?
Percent Change From Baseline to Post Intervention on Mobility (time frame: baseline, immediately after intervention and 2 weeks post intervention). The study lists 4 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 5 Jun 2019.