Normal AgingMINDSNCT04050046
Noninvasive Brain Stimulation to Enhance Cognitive Training in Older Adults
A study testing Transcranial Direct Current Stimulation and Computer-based cognitive therapy (CBCT) in people with Normal Aging, run by University of Pennsylvania.
Trial summary
This research study explores the feasibility of pairing computer-based cognitive training (CBCT) with transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, in order to enhance and preserve mental skills in older adults. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Aging
- What is being tested?
- Transcranial Direct Current Stimulation and Computer-based cognitive therapy (CBCT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 18 Aug 2015to 1 Aug 2018
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Normal cognition
- English as their native language
Who cannot join
- . History of neurological disorders
- . History of head injury with unconsciousness lasting more than 5 minutes
- . History of psychiatric disorders
- . Currently abusing alcohol or drugs (prescription or otherwise)
- . History of epilepsy or seizures within the past 6 months
- . Previous brain surgery
- . Pacemaker
About this study
Official title: Noninvasive Brain Stimulation to Enhance Cognitive Training and Assess Neuroplasticity in Older Adults
This research study explores the feasibility of pairing computer-based cognitive training (CBCT) with transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, in order to enhance and preserve mental skills in older adults. The investigators aim to enhance participants ability to perform tasks of memory, attention, processing speed and other areas of cognition. Additionally, researchers are interested in the ability of the brain to adapt to change-neuroplasticity. Neuroplasticity is thought to impact how individuals respond to cognitive training and tDCS. In order to look at individual differences in neuroplasticity transcranial magnetic stimulation (TMS), a noninvasive brain stimulation technique, will be used. Individual responses to TMS can be used as a marker of neuroplastic changes in brain function, in order to reveal the relationship between brain plasticity and tDCS-induced changes in cognitive ability.
Read the detailed description
Promising evidence suggests that cognitive training regimens may have some beneficial effects on cognition in older adults. However, the improvement from computer-based cognitive training (CBCT) diminish over time which highlights a fundamental challenge for CBCT interventions. Transcranial direct current stimulation (tDCS) can enhance certain cognitive skills, particularly when stimulation is combined with rehearsal of relevant behaviors. Importantly, these benefits have been shown to persist up to 2 months after the intervention.
This study will lay the groundwork for larger scale studies that will combine CBCT with neuromodulation, potentially leading to the development of a persistent, transferrable, multimodal technique to preserve cognition in older adults. In this study, participants will be randomly assigned to receive either real or sham tDCS for 5 consecutive days in conjunction with CBCT. The participant's cognition will be assessed with a neuropsychological assessment at baseline, 1 week, 2 weeks, and 2 months in order to determine any changes.
Additionally, transcranial magnetic stimulation (TMS) will be used to characterize the relationship between baseline differences in brain plasticity and cognitive changes induced by tDCS+CBCT. The effects of TMS on cortical activity have been shown to depend on a variety of neuroplasticity-related mechanisms. In this study, changes in motor physiology (called motor evoked potentials (MEPs)) induced by TMS will be used. Stimulation of the motor cortex with TMS induces robust, transient, and readily quantifiable changes in motor excitability, which are sensitive to changes in the mechanisms of neuroplasticity. Investigators hypothesize that individual variability in brain plasticity, measured by changes in MEP response to TMS, will predict the degree of cognitive benefit afforded by tDCS+CBCT.
Study Visits:
---------------- Visit 1 - Consent and Screening (2 hours) Review enrollment documents and conduct baseline neuropsychological assessment
---------------- Visit 2 - Visit 5 - tDCS + CBCT (30 minutes) Subjects will receive either real or sham stimulation along with cognitive training
--------------- Visit 6 - tDCS + CBCT \& Follow-up (3 hours) Subjects will receive either real or sham stimulation along with cognitive training \& follow-up neurospychological assessment
--------------- Visit 7 - TMS (3 hours) Subjects will receive TMS in order to induce MEPs
------------ Visit 8 - 2 week follow-up (1 .5 hours) Follow-up neuropsychological assessment
----------- Visit 9 - 2 month follow-up (1.5 hours) Follow-up neuropsycological assessment
- Conditions
- Normal Aging
- Being tested
- Transcranial Direct Current Stimulation, Computer-based cognitive therapy (CBCT)
- Keywords
- non-invasive brain stimulation, cognition, transcranial direct current stimulation (tDCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
tDCS is a neuromodulatory technique that delivers a small electric current (about the equivalent of a 9V battery) to the head. A fixed current between 1 and 2 mA is typically applied. tDCS works by applying a positive (anodal) or negative (cathodal) current via electrodes to an area, facilitating the depolarization or hyperpolarization of neurons, respectively.
Computer-based cognitive therapy (CBCT)Behavioural
Repetitive, drill-like training usually presented in the form of a game that targets a specific cognitive construct.
| Study group | Role | What they receive |
|---|---|---|
| Real tDCS + CBCT | Active comparator | 20 minutes of 2.0mA of tDCS for 5 consecutive days Receives: Device: Transcranial Direct Current Stimulation; Behavioral: Computer-based cognitive therapy (CBCT) |
| Sham + CBCT | Sham comparator | Sham stimulation closely imitates reals tDCS 30 second ramp-up / ramp-down Receives: Device: Transcranial Direct Current Stimulation; Behavioral: Computer-based cognitive therapy (CBCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Function
Change in tDCS induced executive function as measured by the Delis-Kaplan Executive Function Systems (DKEFS) test.
DKEFS utilizes a scaled score which ranges from 1-20 with scores between 8-12 considered average.
Measured: baseline, day 5, 2 week, 2 months
Secondary outcomes (1)
TMS brain activation
Change in average amplitude of MEPs as a response to TMS. We expect to see an initial reduction (or inhibition) in average amplitude of the MEP response to TMS, followed by a return to baseline amplitude.
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start18 Aug 2015
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal AgingStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either receive real or sham tDCS without the option of crossover.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04050046
- Sponsor's protocol ID
- 822954
- Acronym
- MINDS
- Status last verified
- Feb 2021
- First submitted
- 30 Jul 2019
- Last updated
- 11 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Brain Stimulation to Enhance Cognitive Training and Assess Neuroplasticity in Older Adults
- ClinicalTrials.gov ID
- NCT04050046
- Acronym / sponsor ID
- MINDS / 822954
- Conditions
- Normal Aging
- Keywords
- non-invasive brain stimulation, cognition, transcranial direct current stimulation (tDCS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 18 Aug 2015 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 8 Aug 2019 (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.
This research study explores the feasibility of pairing computer-based cognitive training (CBCT) with transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, in order to enhance and preserve mental skills in older adults. The investigators aim to enhance participants ability to perform tasks of memory, attention, processing speed and other areas of cognition. Additionally, researchers are interested in the ability of the brain to adapt to change-neuroplasticity. Neuroplasticity is thought to impact how individuals respond to cognitive training and tDCS. In order to look at individual differences in neuroplasticity transcranial magnetic stimulation (TMS), a noninvasive brain stimulation technique, will be used. Individual responses to TMS can be used as a marker of neuroplastic changes in brain function, in order to reveal the relationship between brain plasticity and tDCS-induced changes in cognitive ability.
Detailed description
Promising evidence suggests that cognitive training regimens may have some beneficial effects on cognition in older adults. However, the improvement from computer-based cognitive training (CBCT) diminish over time which highlights a fundamental challenge for CBCT interventions. Transcranial direct current stimulation (tDCS) can enhance certain cognitive skills, particularly when stimulation is combined with rehearsal of relevant behaviors. Importantly, these benefits have been shown to persist up to 2 months after the intervention.
This study will lay the groundwork for larger scale studies that will combine CBCT with neuromodulation, potentially leading to the development of a persistent, transferrable, multimodal technique to preserve cognition in older adults. In this study, participants will be randomly assigned to receive either real or sham tDCS for 5 consecutive days in conjunction with CBCT. The participant's cognition will be assessed with a neuropsychological assessment at baseline, 1 week, 2 weeks, and 2 months in order to determine any changes.
Additionally, transcranial magnetic stimulation (TMS) will be used to characterize the relationship between baseline differences in brain plasticity and cognitive changes induced by tDCS+CBCT. The effects of TMS on cortical activity have been shown to depend on a variety of neuroplasticity-related mechanisms. In this study, changes in motor physiology (called motor evoked potentials (MEPs)) induced by TMS will be used. Stimulation of the motor cortex with TMS induces robust, transient, and readily quantifiable changes in motor excitability, which are sensitive to changes in the mechanisms of neuroplasticity. Investigators hypothesize that individual variability in brain plasticity, measured by changes in MEP response to TMS, will predict the degree of cognitive benefit afforded by tDCS+CBCT.
Study Visits:
---------------- Visit 1 - Consent and Screening (2 hours) Review enrollment documents and conduct baseline neuropsychological assessment
---------------- Visit 2 - Visit 5 - tDCS + CBCT (30 minutes) Subjects will receive either real or sham stimulation along with cognitive training
--------------- Visit 6 - tDCS + CBCT \& Follow-up (3 hours) Subjects will receive either real or sham stimulation along with cognitive training \& follow-up neurospychological assessment
--------------- Visit 7 - TMS (3 hours) Subjects will receive TMS in order to induce MEPs
------------ Visit 8 - 2 week follow-up (1 .5 hours) Follow-up neuropsychological assessment
----------- Visit 9 - 2 month follow-up (1.5 hours) Follow-up neuropsycological assessment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are assigned to either receive real or sham tDCS without the option of crossover.
| Arm | Type | Receives |
|---|---|---|
| Real tDCS + CBCT | Active comparator | Device: Transcranial Direct Current Stimulation, Behavioral: Computer-based cognitive therapy (CBCT)20 minutes of 2.0mA of tDCS for 5 consecutive days |
| Sham + CBCT | Sham comparator | Device: Transcranial Direct Current Stimulation, Behavioral: Computer-based cognitive therapy (CBCT)Sham stimulation closely imitates reals tDCS 30 second ramp-up / ramp-down |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Normal cognition
- English as their native language
Key exclusion criteria (7 listed)
- . History of neurological disorders
- . History of head injury with unconsciousness lasting more than 5 minutes
- . History of psychiatric disorders
- . Currently abusing alcohol or drugs (prescription or otherwise)
- . History of epilepsy or seizures within the past 6 months
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 StimulationtDCS is a neuromodulatory technique that delivers a small electric current (about the equivalent of a 9V battery) to the head. A fixed current between 1 and 2 mA is typically applied. tDCS works by applying a positive (anodal) or negative (cathodal) current via electrodes to an area, facilitating the depolarization or hyperpolarization of neurons, respectively. | Device | Real tDCS + CBCT, Sham + CBCT |
| Computer-based cognitive therapy (CBCT)Repetitive, drill-like training usually presented in the form of a game that targets a specific cognitive construct. | Behavioural | Real tDCS + CBCT, Sham + CBCT |
Primary outcome
Executive Function
Time frame: baseline, day 5, 2 week, 2 months
Change in tDCS induced executive function as measured by the Delis-Kaplan Executive Function Systems (DKEFS) test. DKEFS utilizes a scaled score which ranges from 1-20 with scores between 8-12 considered average.
1 secondary outcome
TMS brain activation
Time frame: 2 week
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 11 Feb 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation and Computer-based cognitive therapy (CBCT) in people with Normal Aging, run by University of Pennsylvania.
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 7 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 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Executive Function (time frame: baseline, day 5, 2 week, 2 months). 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 11 Feb 2021.