Mild Cognitive ImpairmentNCT02596906
Brain and Cognitive Changes After Reasoning Training in Individuals With Mild Cognitive Impairment
A study testing tDCS in people with Mild Cognitive Impairment, run by The University of Texas at Dallas at 1 site in United States.
Trial summary
Individuals aged 55 and older may experience negative effects of cognitive decline. The proposed research seeks to evaluate the benefits of different types of interventions: reasoning training following transcranial direct current stimulation (tDCS) and reasoning training following sham transcranial direct current… Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2018
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Safely have an MRI
- Cognitive complaints in the absence of dementia
- Participate in tasks involving motor abilities such as use of at least one arm and hand
- Read, speak, and comprehend English
- 50-80 years of age
- Comprehend simple instructions, perform tasks, and take part in intervention
Who cannot join
- Not proficient in reading, comprehending, or speaking English
- Individuals who have any significant health, neurological, or psychiatric illness, or history of substance abuse
- Individuals with any MR contraindications (i.e., non-removable metal within/on the body)
- Individuals taking medications which are contraindicatory for the tDCS procedure
- Individuals who are left-handed
- Not proficient in reading,comprehending, and speaking English
Show all 9Show fewer
- Females who are not post-menopausal
- Pre-existing cerebral palsy, autism, epilepsy, schizophrenia, pervasive developmental disorder, thyroid diseases, diabetes, claustrophobia, non-correctable vision problems, major depression, psychosis, active behavioral disorder, or uncontrolled epilepsy.
- Women who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain and Cognitive Changes After Reasoning Training in Individuals With Cognitive Complaints
Individuals aged 55 and older may experience negative effects of cognitive decline. The proposed research seeks to evaluate the benefits of different types of interventions: reasoning training following transcranial direct current stimulation (tDCS) and reasoning training following sham transcranial direct current stimulation (tDCS) on frontal- lobe mediated cognitive measures of executive control in adults with memory complaints, in the absence of dementia.
Read the detailed description
The purpose of this study is to evaluate the impact of reasoning training on individuals with complaints of changes in memory or thinking in the absence of dementia, when combined with transcranial current stimulation (tDCS). The reasoning training being studied is a strategy based program where individuals are taught strategies designed to engage the frontal lobes. Participants will randomly be placed into one of two groups (1) reasoning training following transcranial current stimulation (tDCS) as compared to (2) reasoning training following sham tDCS. The study will be done with adults between the ages of 50 and 80 with consistent memory complaints or lower baseline performance on memory measures. The primary hypothesis is that individuals receiving tDCS prior to brain training will have a stronger response to brain training than those in the sham tDCS group. Response to training will be measured by improved cognitive function and neural changes as measured by neuropsychological testing, MRI, and EEG. MRI will be used to evaluate the impact of reasoning training on brain blood flow, structure and function, and to measure changes in brain energy metabolism and electroencephalogram (EEG) to evaluate intervention outcomes. The reasoning training program will be conducted in small groups at the Center for BrainHealth.
- Conditions
- Mild Cognitive Impairment
- Being tested
- tDCS, Sham tDCS
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session.
Sham tDCSDevice
For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group.
| Study group | Role | What they receive |
|---|---|---|
| tDCS+Training | Experimental | This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks Receives: Device: tDCS |
| Sham tDCS+training | Sham comparator | This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in California Verbal Learning Task Score
To examine short-term and long-term effects of treatment on cognition and real-life outcomes. The participant will undergo neuropsychological testing at baseline, post-training (4 weeks), as well as 3-months post-training.
Scores on the scale range from 0 to 16 on the California Verbal Learning Task. Higher the values are better their memory.
Measured: Baseline to 4 weeks and 3 months post-training
Secondary outcomes (1)
Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation
Non-invasive estimation of rCBF by perfusion maps using pseudo-continuous arterial spin labeling (pCASL) MRI. rCBF is quantified as mL/min/100g tissue.
Measured: Two longitudinal measurements at baseline and 1-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2018
- Study completionJan 2018
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 Mild Cognitive ImpairmentStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Chapman, PhD, The University of Texas at Dallas
- Investigators
- Sandra Chapman, PhD, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596906
- Sponsor's protocol ID
- CBH-MCI-tDCS
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2015
- Last updated
- 30 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Hsu WY, Ku Y, Zanto TP, Gazzaley A. Effects of noninvasive brain stimulation on cognitive function in healthy aging and Alzheimer's disease: a systematic review and meta-analysis. Neurobiol Aging. 2015 Aug;36(8):2348-59. doi: 10.1016/j.neurobiolaging.2015.04.016. Epub 2015 May 1.
PubMed 26022770
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain and Cognitive Changes After Reasoning Training in Individuals With Cognitive Complaints
- ClinicalTrials.gov ID
- NCT02596906
- Acronym / sponsor ID
- CBH-MCI-tDCS
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 4 Nov 2015 (estimated)
- Results
- Posted 11 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals aged 55 and older may experience negative effects of cognitive decline. The proposed research seeks to evaluate the benefits of different types of interventions: reasoning training following transcranial direct current stimulation (tDCS) and reasoning training following sham transcranial direct current stimulation (tDCS) on frontal- lobe mediated cognitive measures of executive control in adults with memory complaints, in the absence of dementia.
Detailed description
The purpose of this study is to evaluate the impact of reasoning training on individuals with complaints of changes in memory or thinking in the absence of dementia, when combined with transcranial current stimulation (tDCS). The reasoning training being studied is a strategy based program where individuals are taught strategies designed to engage the frontal lobes. Participants will randomly be placed into one of two groups (1) reasoning training following transcranial current stimulation (tDCS) as compared to (2) reasoning training following sham tDCS. The study will be done with adults between the ages of 50 and 80 with consistent memory complaints or lower baseline performance on memory measures. The primary hypothesis is that individuals receiving tDCS prior to brain training will have a stronger response to brain training than those in the sham tDCS group. Response to training will be measured by improved cognitive function and neural changes as measured by neuropsychological testing, MRI, and EEG. MRI will be used to evaluate the impact of reasoning training on brain blood flow, structure and function, and to measure changes in brain energy metabolism and electroencephalogram (EEG) to evaluate intervention outcomes. The reasoning training program will be conducted in small groups at the Center for BrainHealth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS+Training | Experimental | Device: tDCSThis group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks |
| Sham tDCS+training | Sham comparator | Device: Sham tDCSThis group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Safely have an MRI
- Cognitive complaints in the absence of dementia
- Participate in tasks involving motor abilities such as use of at least one arm and hand
- Read, speak, and comprehend English
- 50-80 years of age
Key exclusion criteria (9 listed)
- Not proficient in reading, comprehending, or speaking English
- Individuals who have any significant health, neurological, or psychiatric illness, or history of substance abuse
- Individuals with any MR contraindications (i.e., non-removable metal within/on the body)
- Individuals taking medications which are contraindicatory for the tDCS procedure
- Individuals who are left-handed
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 |
|---|---|---|
| tDCSPrior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session. | Device | tDCS+Training |
| Sham tDCSFor the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group. | Device | Sham tDCS+training |
Primary outcome
Change From Baseline in California Verbal Learning Task Score
Time frame: Baseline to 4 weeks and 3 months post-training
To examine short-term and long-term effects of treatment on cognition and real-life outcomes. The participant will undergo neuropsychological testing at baseline, post-training (4 weeks), as well as 3-months post-training. Scores on the scale range from 0 to 16 on the California Verbal Learning Task. Higher the values are better their memory.
1 secondary outcome
Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation
Time frame: Two longitudinal measurements at baseline and 1-month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26022770Hsu WY, Ku Y, Zanto TP, Gazzaley A. Effects of noninvasive brain stimulation on cognitive function in healthy aging and Alzheimer's disease: a systematic review and meta-analysis. Neurobiol Aging. 2015 Aug;36(8):2348-59. doi: 10.1016/j.neurobiolaging.2015.04.016. Epub 2015 May 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.
Sandra Chapman, PhD principal investigator
The University of Texas at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Mild Cognitive Impairment, run by The University of Texas at Dallas 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 6 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 30 Oct 2023. 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 11 Dec 2020). 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 From Baseline in California Verbal Learning Task Score (time frame: Baseline to 4 weeks and 3 months post-training). 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 NCT02596906, 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 30 Oct 2023.