Mild Cognitive Impairment
Conditions
Brief 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 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.
Interventions
DEVICEtDCS
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.
DEVICESham tDCS
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.
Sponsors
The University of Texas at Dallas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in California Verbal Learning Task Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation | Two longitudinal measurements at baseline and 1-month | Non-invasive estimation of rCBF by perfusion maps using pseudo-continuous arterial spin labeling (pCASL) MRI. rCBF is quantified as mL/min/100g tissue. |
Countries
United States
Participant flow
Recruitment details
22 participants consented for the study of which 15 were included in the final analysis.
Pre-assignment details
331 participants were screened for eligibility criteria, of which 52 participants were eligible for the study. Of the 52, a total of 30 participants dropped out due to time constraints, inability to complete the scans and/or after recommendation by the neurologist who questioned if they truly met eligibility criteria.
Participants by arm
| Arm | Count |
|---|---|
| tDCS+Training This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks
tDCS: 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. | 8 |
| Sham tDCS+Training This group will receive 20 minutes of sham tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.
Sham tDCS: 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. | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | tDCS+Training | Sham tDCS+Training | Total |
|---|---|---|---|
| Age, Continuous | 64.17 years STANDARD_DEVIATION 6.93 | 63.30 years STANDARD_DEVIATION 7.38 | 63.91 years STANDARD_DEVIATION 6.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 3 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 7 |
| other Total, other adverse events | 2 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
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.
Time frame: Baseline to 4 weeks and 3 months post-training
Population: 22 participants consented to the study of which 15 participants were in the final analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| tDCS+Training | Change From Baseline in California Verbal Learning Task Score | Baseline to 3-month follow-up | 4.22 score on a scale | Standard Deviation 1.45 |
| tDCS+Training | Change From Baseline in California Verbal Learning Task Score | Baseline to 4 weeks | 3.04 score on a scale | Standard Deviation 1.22 |
| Sham tDCS+Training | Change From Baseline in California Verbal Learning Task Score | Baseline to 3-month follow-up | 7.04 score on a scale | Standard Deviation 1.44 |
| Sham tDCS+Training | Change From Baseline in California Verbal Learning Task Score | Baseline to 4 weeks | 5.17 score on a scale | Standard Deviation 2.22 |
Secondary
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.
Time frame: Two longitudinal measurements at baseline and 1-month
Population: Participants between ages 50-80 years had a diagnosis of mild cognitive impairment (MCI)based on Petersen's or Alzheimer's Disease Neuroimaging Initiative (ADNI) criteria from the Dallas-Fort worth community.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| tDCS+Training | Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation | 0.19 ml/min/100g tissue scaled by whole brain |
| Sham tDCS+Training | Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation | -0.12 ml/min/100g tissue scaled by whole brain |