Alzheimer DiseaseNCT05270408
Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia
A study testing Active Transcranial direct current stimulation (STARStim 8) in people with Alzheimer Disease and Mild Cognitive Impairment, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The research objective of this study is to examine the efficacy of HD-tDCS to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be three treatment arms: two active HD-tDCS (1 mA or 2 mA) and a sham group. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- What is being tested?
- Active Transcranial direct current stimulation (STARStim 8)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2022to 15 Feb 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 and older
- Fluent in English
- Active diagnosis of MCI or dementia
Who cannot join
- Substance use disorder
- Has metal fragments in head
- Taking medications that may interact with the HD-tDCS effect (i.e., amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, dextromethorphan, D-cycloserine, flunarizine, or ropinirole)
Trial locations and contacts
1 site in 1 country.
About this study
The research objective of this study is to examine the efficacy of HD-tDCS to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be three treatment arms: two active HD-tDCS (1 mA or 2 mA) and a sham group. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up.
Read the detailed description
This is a pilot study being done to attempt to improve verbal episodic memory in persons with mild cognitive impairment (MCI) and dementia. Although the hippocampus is a brain structure most often associated with early deficits in MCI and dementia, the pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (DACC) have been shown to play a role in verbal episodic memory for such patients. The purpose of this study is to examine the efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI and dementia. Entraining the preSMA/DACC circuit with 10 sessions at one of two levels of HD-tDCS will allow the researchers to investigate whether neuromodulation may be used to improve verbal episodic memory. Participants will receive 10 sessions at one of two levels of active stimulation (1 mA or 2 mA anodal HD-tDCS targeting preSMA/DACC for 20 min) or sham across 2 weeks. The device is used to deliver high definition transcranial direct current stimulation to targeted regions. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up. The investigators plan to recruit English-speaking participants aged 50 years and older with MCI and dementia. Participants will be randomized into HD-tDCS conditions.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Being tested
- Active Transcranial direct current stimulation (STARStim 8), Sham Transcranial direct current stimulation (STARStim 8)
- Keywords
- Transcranial direct current stimulation, Alzheimer Disease, Mild Cognitive Impairment, Dementia, MCI, Mild neurocognitive disorder, Amnestic, Pre- alzheimer
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcranial direct current stimulation (STARStim 8)Device
Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 1mA to the scalp.
Active Transcranial direct current stimulation (STARStim 8)Device
Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp.
Sham Transcranial direct current stimulation (STARStim 8)Device
Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation at 1mA | Experimental | Participants will receive 1 mA active HD-tDCS for 20 minutes. Receives: Device: Active Transcranial direct current stimulation (STARStim 8) |
| Active stimulation at 2mA | Experimental | Participants will receive 2 mA active HD-tDCS for 20 minutes. Receives: Device: Active Transcranial direct current stimulation (STARStim 8) |
| Sham group | Sham comparator | Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation. Receives: Device: Sham Transcranial direct current stimulation (STARStim 8) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)
The RAVLT is a verbal episodic memory task where a list of 15 words is read aloud for 5 consecutive trials followed by a 20 minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-75. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-15. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured as the primary outcomes.
Measured: Baseline, immediately following last treatment session, and 2-months post treatment
Secondary outcomes (7)
Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R)
The BVMT-R is a visual episodic memory task where 6 simple designs are shown for 10 seconds in a 2 x 3 matrix for 3 learning trials followed by a 25-minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-36. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-12. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better visual episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured.
Measured: Baseline, immediately following last treatment session, and 2-months post treatment
Change in Score on the Boston Naming Test Short Form
The Boston Naming Test Short Form is a 30 item version of the task (odd and even item versions of the full test) and a measure of language. The subject is shown pictures of objects and is required to correctly name them as quickly as possible. The outcome measure for this task is the total number of correct responses, ranging from 0-30. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.
Measured: Baseline, immediately following last treatment session, and 2-months post treatment
Change in Score on the Delis Kaplan Executive Function System (DKEFS) Phonemic Fluency
The DKEFS phonemic verbal fluency task is a measure of language. The subject is required to name as many words as possible that begin with specified letters within 1 minute. Three different letter trials are completed. The outcome measure for this task is the total number of correct responses across the trials, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.
Measured: Baseline, immediately following last treatment session, and 2-months post treatment
Change in Score on the Delis Kaplan Executive Function System (DKEFS) Semantic Fluency
The DKEFS semantic verbal fluency task is a measure of language and involves 3 conditions. The subject is required to name as many animals and people names as possible within 1 minute. The outcome measure for this task is the total number of correct responses for both conditions combined, ranging from 0-90. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.
Measured: Baseline, immediately following last treatment session, and 2-months post treatment
Change in Score on the Trail Making Test
The Trail Making Test is a measure of cognitive flexibility and executive functions. The task requires the subject to as quickly as possible complete two conditions, involving number sequencing and then number-letter switching. The outcome measure for this task is the time in seconds to complete the number-letter switching condition, ranging from 15-300. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.
Measured: Baseline, immediately following last treatment session, and 2-months post treatment
Change in Score on the Southwestern Assessment of Processing Speed
The Southwestern Assessment of Processing Speed is a measure of psychomotor processing speed. The subject is required to transcribe numbers to their corresponding written symbol as quickly as possible within 60 seconds. The outcome measure for this task is the total number of correct responses, ranging from 0-75. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.
Measured: Baseline, immediately following last treatment session, and 2-months post treatment
Change in Score on the DKEFS Color-Word Interference Test
The DKEFS Color-Word Interference test is a measure of information processing speed and complex attention. The task requires the subject to as quickly as possible complete four conditions, involving color naming, word reading, response inhibition, and then switching back-and-forth between two response patterns. The outcome measures for this task was the response inhibition trial and the switching trial, which are scored as the time in seconds to complete the conditions, ranging from 20-180. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better performance. Changes from baseline to the last HD-tDCS session and the 2-month follow-up will be measured.
Measured: Baseline, immediately following last treatment session, and 2-months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start13 Jul 2022
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Lobue, University of Texas Southwestern Medical Center
- Investigators
- Christian LoBue, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270408
- Sponsor's protocol ID
- STU-2021-0974
- Status last verified
- Feb 2025
- First submitted
- 30 Dec 2021
- Last updated
- 5 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
LoBue C, Chiang HS, Salter A, McClintock S, Nguyen TP, Logan R, Smernoff E, Pandya S, Hart J. High definition transcranial direct current stimulation as an intervention for cognitive deficits in Alzheimer's dementia: A randomized controlled trial. J Prev Alzheimers Dis. 2025 Feb;12(2):100023. doi: 10.1016/j.tjpad.2024.100023. Epub 2025 Jan 1.
PubMed 39863318
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Brain Stimulation in Mild Cognitive Impairment and Dementia
- ClinicalTrials.gov ID
- NCT05270408
- Acronym / sponsor ID
- STU-2021-0974
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Keywords
- Transcranial direct current stimulation, Alzheimer Disease, Mild Cognitive Impairment, Dementia, MCI, Mild neurocognitive disorder, Amnestic, Pre- alzheimer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 8 Mar 2022 (actual)
- Results
- Posted 5 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research objective of this study is to examine the efficacy of HD-tDCS to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI or dementia after 10 sessions of HD-tDCS. There will be three treatment arms: two active HD-tDCS (1 mA or 2 mA) and a sham group. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up.
Detailed description
This is a pilot study being done to attempt to improve verbal episodic memory in persons with mild cognitive impairment (MCI) and dementia. Although the hippocampus is a brain structure most often associated with early deficits in MCI and dementia, the pre-supplemental motor area (preSMA) and dorsal anterior cingulate cortex (DACC) have been shown to play a role in verbal episodic memory for such patients. The purpose of this study is to examine the efficacy of high-definition transcranial direct current stimulation (HD-tDCS) to the preSMA/DACC region and its influence on verbal episodic memory in patients with MCI and dementia. Entraining the preSMA/DACC circuit with 10 sessions at one of two levels of HD-tDCS will allow the researchers to investigate whether neuromodulation may be used to improve verbal episodic memory. Participants will receive 10 sessions at one of two levels of active stimulation (1 mA or 2 mA anodal HD-tDCS targeting preSMA/DACC for 20 min) or sham across 2 weeks. The device is used to deliver high definition transcranial direct current stimulation to targeted regions. A verbal episodic memory task will be completed at baseline, immediately following the last HD-tDCS session, and a 2-month follow-up. The investigators plan to recruit English-speaking participants aged 50 years and older with MCI and dementia. Participants will be randomized into HD-tDCS conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active stimulation at 1mA | Experimental | Device: Active Transcranial direct current stimulation (STARStim 8)Participants will receive 1 mA active HD-tDCS for 20 minutes. |
| Active stimulation at 2mA | Experimental | Device: Active Transcranial direct current stimulation (STARStim 8)Participants will receive 2 mA active HD-tDCS for 20 minutes. |
| Sham group | Sham comparator | Device: Sham Transcranial direct current stimulation (STARStim 8)Participants will receive sham HD-tDCS for 20 minutes, meaning no stimulation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 50 and older
- Fluent in English
- Active diagnosis of MCI or dementia
Key exclusion criteria (3 listed)
- Substance use disorder
- Has metal fragments in head
- Taking medications that may interact with the HD-tDCS effect (i.e., amphetamines, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, dextromethorphan, D-cycloserine, flunarizine, or ropinirole)
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 Transcranial direct current stimulation (STARStim 8)Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 1mA to the scalp. | Device | Active stimulation at 1mA |
| Active Transcranial direct current stimulation (STARStim 8)Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver 2mA to the scalp. | Device | Active stimulation at 2mA |
| Sham Transcranial direct current stimulation (STARStim 8)Participants wear a neoprene cap on their head and electrodes filled with gel are attached and will deliver no current to the scalp. | Device | Sham group |
Primary outcome
Change in Score on the Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Baseline, immediately following last treatment session, and 2-months post treatment
The RAVLT is a verbal episodic memory task where a list of 15 words is read aloud for 5 consecutive trials followed by a 20 minute delayed recall trial. The number of items recalled immediately after each trial are summed to create a total learning score, ranging from 0-75. Also, the number of items recalled for the delayed trial are recorded as a delayed recall score, ranging from 0-15. Scores were converted to standardized scores (T-scores) using normative data, ranging from 2-86. Higher scores reflect better episodic memory performance. Changes from baseline for the total learning and delayed recall scores at the last HD-tDCS session and the 2-month follow-up will be measured as the primary outcomes.
7 secondary outcomes
Change in Score on the Brief Visuospatial Memory Test-Revised (BVMT-R)
Time frame: Baseline, immediately following last treatment session, and 2-months post treatment
Change in Score on the Boston Naming Test Short Form
Time frame: Baseline, immediately following last treatment session, and 2-months post treatment
Change in Score on the Delis Kaplan Executive Function System (DKEFS) Phonemic Fluency
Time frame: Baseline, immediately following last treatment session, and 2-months post treatment
Change in Score on the Delis Kaplan Executive Function System (DKEFS) Semantic Fluency
Time frame: Baseline, immediately following last treatment session, and 2-months post treatment
Change in Score on the Trail Making Test
Time frame: Baseline, immediately following last treatment session, and 2-months post treatment
Change in Score on the Southwestern Assessment of Processing Speed
Time frame: Baseline, immediately following last treatment session, and 2-months post treatment
Change in Score on the DKEFS Color-Word Interference Test
Time frame: Baseline, immediately following last treatment session, and 2-months post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39863318LoBue C, Chiang HS, Salter A, McClintock S, Nguyen TP, Logan R, Smernoff E, Pandya S, Hart J. High definition transcranial direct current stimulation as an intervention for cognitive deficits in Alzheimer's dementia: A randomized controlled trial. J Prev Alzheimers Dis. 2025 Feb;12(2):100023. doi: 10.1016/j.tjpad.2024.100023. Epub 2025 Jan 1.
- 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.
Christian LoBue, PhD principal investigator
University of Texas Southwestern Medical Center
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 Transcranial direct current stimulation (STARStim 8) in people with Alzheimer Disease and Mild Cognitive Impairment, run by University of Texas Southwestern Medical Center 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 3 inclusion and 3 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 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Score on the Rey Auditory Verbal Learning Test (RAVLT) (time frame: Baseline, immediately following last treatment session, and 2-months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05270408, which also lists 1 linked publication.
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 Mar 2025.