Cognitive ImpairmentNCT06665022
Neuromodulation Effects in Older Adults
A study testing Active tDCS in people with Cognitive Impairment and Cognitive Decline, run by University of Florida at 1 site in United States.
Trial summary
The current study is a mechanistic study to evaluate working memory gains from application of transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Cognitive Decline
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2024to 1 Dec 2024
- 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 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60-95 years
- Montreal Cognitive Assessment (MoCA) score 18 and above (scores will be adjusted for education)
- Able to receive electrical stimulation
- Adequate motor capacity to participate in intervention and training sessions
Who cannot join
- Contraindications to MRI recording
- Left-handed
- Inability to communicate in English
- History of neurological/psychiatric disorders and traumatic brain injury
- Incidence of stroke
- Severe visual and hearing impairment precluding completion of study assessments
Trial locations and contacts
1 site in 1 country.
About this study
The current study is a mechanistic study to evaluate working memory gains from application of transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control
Read the detailed description
The current study is a mechanistic study to evaluate working memory gains with transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control. The proposed study investigates the effects of acute (one-time) tDCS application on working memory gains (i.e., behavior and functional) by evaluating brain structure and cognitive function relationships. tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and enhances neural plasticity when paired with a training task. A mechanistic, in-scanner, crossover design tDCS study (active and sham stimulation) with 2milliamps (mA) fixed dosing application will enroll 110 participants comprising 55 cognitively normal/healthy older adults and 55 older adults with MCI. The study will employ multi-modal neuroimaging (structural and functional data), person-specific computational models, and machine learning to elucidate acute tDCS effects on working memory. Change in cognitive function (i.e., working memory performance) will be quantified using working memory tasks and magnetic resonance imaging (MRI). The investigators will compare changes in working memory performance resulting from active tDCS versus sham tDCS during 2-back task compared to 0-back task.
The investigators will test the following hypotheses:
- Acute tDCS will increase working memory performance during active tDCS and larger degree of brain atrophy seen in MCI patients will significantly decrease current intensity in stimulated brain regions.
- Acute tDCS will significantly increase functional connectivity within the working memory network during active tDCS but not sham.
The present study will provide insight into mechanisms underlying tDCS application in MCI population for combating cognitive decline in a rapidly aging population in the United States. Information gathered from this study may guide future intervention strategies to combat cognitive decline and improve the quality of life of aging population.
- Conditions
- Cognitive Impairment, Cognitive Decline
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- Cognitive Aging, Brain Stimulation, functional MRI, Computational Modeling, Finite Element Method (FEM)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSDevice
A neuroConn MR-safe 1x1 tDCS stimulator will be used to apply 12 minutes of 2.0 mA electrical current, with 30 seconds ramps up and 30 seconds ramps down. The electrical current will be applied by using two carbon rubber electrodes (one anode, one cathode) with added ten20 conductive paste. The electrode+paste will be affixed on the participant's scalp over the frontal cortices at F3 and F4 location (EEG 10-20 system). Inflow of current (anode) will occur at F4 location, and outflow of current will occur at F3 (cathode). For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group.
Sham tDCSDevice
Sham stimulation will be performed with the same 1x1 device. Participants will receive 2 mA of direct current stimulation for 30 seconds with 30 seconds ramps up and down. This provides the tingling and prickling sensation on the scalp associated with tDCS while prevent delivering sufficient current (12 minutes) to penetrate the skull and stimulate the brain. Prep in sham conditions will be identical to active stimulation conditions. For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | A neuroConn MR-safe 1x1 tDCS stimulator will be used to apply 12 minutes of 2.0 mA electrical current, with 30 seconds ramps up and 30 seconds ramps down. The electrical current will be applied by using two carbon rubber electrodes (one anode, one cathode) with added ten20 conductive paste. The electrode+paste will be affixed on the participant's scalp over the frontal cortices at F3 and F4 location (EEG 10-20 system). Inflow of current (anode) will occur at F4 location, and outflow of current will occur at F3 (cathode). For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group. Receives: Device: Active tDCS |
| Sham tDCS | Placebo comparator | Sham stimulation will be performed with the same 1x1 device. Participants will receive 2 mA of direct current stimulation for 30 seconds with 30 seconds ramps up and down. This provides the tingling and prickling sensation on the scalp associated with tDCS while prevent delivering sufficient current (12 minutes) to penetrate the skull and stimulate the brain. Prep in sham conditions will be identical to active stimulation conditions. For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-back Working Memory Accuracy
The descriptive name of the scale is 2-back Working Memory Accuracy. Participants will perform in-scanner 0 and 2-back (i.e., N-back) working memory task that asks them to acknowledge whether a letter was the same as the letter 2 or N times before. Participant will view one letter at a time, with a crosshair appear briefly as an inter-stimulus interval. The task paradigm for each run consists of four blocks of 2-back and four blocks of 0-back. Two runs (before and during stimulation) will be performed at each visit.
Measured: 12 minutes versus 24 minutes in each session. Then comparing active versus sham stimulation sessions, separated by at least two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Why it stopped: Study has been absorbed into a pre-existing, IRB-approved (IRB202202370) study with an active Clinical Trials page (NCT05998031). This IRB (IRB202401208) has been withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will enroll in a randomized double-blinded crossover within subject study. Each participant will undergo two MRI sessions. Each MRI session will include either one active tDCS or one sham tDCS. The order of delivering active or sham tDCS first will be randomized. A washout period between active and sham tDCS will be set for at least two-weeks to ensure no after-effect from the first stimulation session will be carried over to the second session.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aprinda I Queen, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665022
- Sponsor's protocol ID
- IRB202401208
- Status last verified
- Nov 2024
- First submitted
- 28 Oct 2024
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Effects in Older Adults
- ClinicalTrials.gov ID
- NCT06665022
- Acronym / sponsor ID
- IRB202401208
- Conditions
- Cognitive Impairment, Cognitive Decline
- Keywords
- Cognitive Aging, Brain Stimulation, functional MRI, Computational Modeling, Finite Element Method (FEM)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has been absorbed into a pre-existing, IRB-approved (IRB202202370) study with an active Clinical Trials page (NCT05998031). This IRB (IRB202401208) has been withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 30 Oct 2024 (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 current study is a mechanistic study to evaluate working memory gains from application of transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control
Detailed description
The current study is a mechanistic study to evaluate working memory gains with transcranial direct current stimulation (tDCS) in older adults with mild cognitive impairments (MCI) compared to cognitively healthy control. The proposed study investigates the effects of acute (one-time) tDCS application on working memory gains (i.e., behavior and functional) by evaluating brain structure and cognitive function relationships. tDCS is a method of non-invasive brain stimulation that directly stimulates brain regions involved in active cognitive function and enhances neural plasticity when paired with a training task. A mechanistic, in-scanner, crossover design tDCS study (active and sham stimulation) with 2milliamps (mA) fixed dosing application will enroll 110 participants comprising 55 cognitively normal/healthy older adults and 55 older adults with MCI. The study will employ multi-modal neuroimaging (structural and functional data), person-specific computational models, and machine learning to elucidate acute tDCS effects on working memory. Change in cognitive function (i.e., working memory performance) will be quantified using working memory tasks and magnetic resonance imaging (MRI). The investigators will compare changes in working memory performance resulting from active tDCS versus sham tDCS during 2-back task compared to 0-back task.
The investigators will test the following hypotheses:
- Acute tDCS will increase working memory performance during active tDCS and larger degree of brain atrophy seen in MCI patients will significantly decrease current intensity in stimulated brain regions.
- Acute tDCS will significantly increase functional connectivity within the working memory network during active tDCS but not sham.
The present study will provide insight into mechanisms underlying tDCS application in MCI population for combating cognitive decline in a rapidly aging population in the United States. Information gathered from this study may guide future intervention strategies to combat cognitive decline and improve the quality of life of aging population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will enroll in a randomized double-blinded crossover within subject study. Each participant will undergo two MRI sessions. Each MRI session will include either one active tDCS or one sham tDCS. The order of delivering active or sham tDCS first will be randomized. A washout period between active and sham tDCS will be set for at least two-weeks to ensure no after-effect from the first stimulation session will be carried over to the second session.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Active tDCSA neuroConn MR-safe 1x1 tDCS stimulator will be used to apply 12 minutes of 2.0 mA electrical current, with 30 seconds ramps up and 30 seconds ramps down. The electrical current will be applied by using two carbon rubber electrodes (one anode, one cathode) with added ten20 conductive paste. The electrode+paste will be affixed on the participant's scalp over the frontal cortices at F3 and F4 location (EEG 10-20 system). Inflow of current (anode) will occur at F4 location, and outflow of current will occur at F3 (cathode). For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group. |
| Sham tDCS | Placebo comparator | Device: Sham tDCSSham stimulation will be performed with the same 1x1 device. Participants will receive 2 mA of direct current stimulation for 30 seconds with 30 seconds ramps up and down. This provides the tingling and prickling sensation on the scalp associated with tDCS while prevent delivering sufficient current (12 minutes) to penetrate the skull and stimulate the brain. Prep in sham conditions will be identical to active stimulation conditions. For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 60-95 years
- Montreal Cognitive Assessment (MoCA) score 18 and above (scores will be adjusted for education)
- Able to receive electrical stimulation
- Adequate motor capacity to participate in intervention and training sessions
Key exclusion criteria (6 listed)
- Contraindications to MRI recording
- Left-handed
- Inability to communicate in English
- History of neurological/psychiatric disorders and traumatic brain injury
- Incidence of stroke
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 |
|---|---|---|
| Active tDCSA neuroConn MR-safe 1x1 tDCS stimulator will be used to apply 12 minutes of 2.0 mA electrical current, with 30 seconds ramps up and 30 seconds ramps down. The electrical current will be applied by using two carbon rubber electrodes (one anode, one cathode) with added ten20 conductive paste. The electrode+paste will be affixed on the participant's scalp over the frontal cortices at F3 and F4 location (EEG 10-20 system). Inflow of current (anode) will occur at F4 location, and outflow of current will occur at F3 (cathode). For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group. | Device | Active tDCS |
| Sham tDCSSham stimulation will be performed with the same 1x1 device. Participants will receive 2 mA of direct current stimulation for 30 seconds with 30 seconds ramps up and down. This provides the tingling and prickling sensation on the scalp associated with tDCS while prevent delivering sufficient current (12 minutes) to penetrate the skull and stimulate the brain. Prep in sham conditions will be identical to active stimulation conditions. For each stimulation condition (active, sham), each participant will perform two runs of N-back working memory task (baseline/pre-stimulation and during stimulation). Sham efficacy will be evaluated as a direct comparison in N-back performance and connectivity results in active group versus sham group. | Device | Sham tDCS |
Primary outcome
2-back Working Memory Accuracy
Time frame: 12 minutes versus 24 minutes in each session. Then comparing active versus sham stimulation sessions, separated by at least two weeks.
The descriptive name of the scale is 2-back Working Memory Accuracy. Participants will perform in-scanner 0 and 2-back (i.e., N-back) working memory task that asks them to acknowledge whether a letter was the same as the letter 2 or N times before. Participant will view one letter at a time, with a crosshair appear briefly as an inter-stimulus interval. The task paradigm for each run consists of four blocks of 2-back and four blocks of 0-back. Two runs (before and during stimulation) will be performed at each visit.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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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.
Aprinda I Queen, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Cognitive Impairment and Cognitive Decline, run by University of Florida 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 4 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: withdrawn, as of the sponsor's last update on 21 Nov 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
2-back Working Memory Accuracy (time frame: 12 minutes versus 24 minutes in each session. Then comparing active versus sham stimulation sessions, separated by at least two weeks.). 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 21 Nov 2024.