HIV, Mild Neurocognitive Disorder
Conditions
Brief summary
The purpose of this study is to develop pilot data on the potential efficacy of computer-based cognitive training or the combination of computer-based cognitive training with transcranial direct current stimulation (tDCS) in improving cognitive function in persons with HIV-related mild neurocognitive disorder (MND).
Detailed description
The purpose of this study is to develop pilot data on the potential efficacy of computer-based cognitive training or the combination of computer-based cognitive training with transcranial direct current stimulation (tDCS) in improving cognitive function in persons with HIV-related mild neurocognitive disorder (MND). tDCS is a noninvasive brain stimulation technique in which a small direct current (1-2 mA) is applied to the scalp during a cognitive or motor activity, inducing a very small current that affects specific neural circuits related to the site at which electrodes are placed. tDCS has been judged safe and has shown significant treatment effects in studies with other populations, but has not been extensively studied in individuals with HIV infection. tDCS has been shown to facilitate learning in a number of studies, suggesting that it may improve or enhance learning in those with cognitive problems. As HIV infection is associated with decrements in a number of cognitive skills, including working memory, executive functions, and psychomotor speed that are related to individuals' functional status and medication adherence, the demonstration of a technique to enhance the effects of cognitive training in this population would have substantial clinical benefits as well as scientific value.
Interventions
DEVICETranscranial direct current stimulation
Direct current stimulation at a current of 1.5 mA with anode at F3 (left dorsolateral prefrontal cortex) and cathode at Fp2 (right frontal pole) for a period of 20 minutes each for 6 sessions over two weeks simultaneously with cognitive training.
PROCEDURECognitive training
Computer delivered intervention designed to improve cognitive speed and executive functioning for a period of 20 minutes each for 6 sessions over two weeks.
DEVICESham transcranial direct current stimulation
Direct current stimulation at a current of 1.5 mA with anode at F3 (left dorsolateral prefrontal cortex) and cathode at Fp2 (right frontal pole) for a period of one minute to simulate active treatment applied in 6 sessions over two weeks.
Sponsors
Nova Southeastern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * Fluent in English * Meets Frascati criteria for mild neurocognitive disorder
Exclusion criteria
* Left handed * Presence of dementia * Use of specific psychotropic medications including antidepressants, antipsychotics, and sleep-promoting medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Working Memory: Participants' Rate of Improvement | 3 weeks | Participants' rate of improvement on a verbal working memory task. Participants completed a battery of cognitive measures administered by an evaluator blind to treatment assignment. We used the Digits Backward trial of the Digit Span subtest of the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV; Pearson Assessment) to measure working memory. We used raw scores for analyses. These are the largest number of digits the participant could remember and repeat in reverse order. Possible range of scores is from zero to 10. Normal persons typically remember from 5 to 7 digits. Higher scores are considered better. Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, helper T cell count, and log viral load as covariates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Center for Epidemiological Studies Depression Scale (CES-D) | 3 weeks | Participants' mood over the course of the study. We used the Center for Epidemiological Studies--Depression scale (CES-D) to measure mood. This measure includes 20 items that ask the person assessed to report his or her experience of mood symptoms over the past two weeks. Participants completed this measure before and after the study intervention. Scores can range from zero to 60, with most persons attaining a score of 15 or less. Higher scores are considered worse as they indicate more frequent or more severe mood symptoms. |
| Patient's Own Assessment of Function (PAOF) | 3 weeks | Patient report of cognitive difficulties on the Patient Assessment of Own Functioning. This scale comprises 33 items describing problems in thinking, language, and memory. Participants rate each items according to how often they experience each problem on a six-point scale from almost never (score of 0) to almost always (score of 5). The participant's score is the sum of ratings on all items. The range of possible scores on each item is from 0 to 5, with most persons achieving a score of 1.5 or lower. Higher scores represent more frequent report of cognitive difficulties and thus are considered worse. The range of all possible scores for the full scale of 33 items is is 0 to 165. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Training Cognitive training Sham tDCS
Transcranial direct current stimulation: Direct current stimulation | 11 |
| Cognitive Training With tDCS Cognitive training Active tDCS
Transcranial direct current stimulation: Direct current stimulation | 10 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 1 |
Baseline characteristics
| Characteristic | Cognitive Training | Total | Cognitive Training With tDCS |
|---|---|---|---|
| Age, Continuous | 46.45 years STANDARD_DEVIATION 10.16 | 47.52 years STANDARD_DEVIATION 8.68 | 48.70 years STANDARD_DEVIATION 7.04 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 15 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 6 Participants | 2 Participants |
| Region of Enrollment United States | 11 Participants | 21 Participants | 10 Participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 14 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 10 |
| other Total, other adverse events | 0 / 11 | 0 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 10 |
Outcome results
Primary
Working Memory: Participants' Rate of Improvement
Participants' rate of improvement on a verbal working memory task. Participants completed a battery of cognitive measures administered by an evaluator blind to treatment assignment. We used the Digits Backward trial of the Digit Span subtest of the Wechsler Adult Intelligence Scale Fourth Edition (WAIS-IV; Pearson Assessment) to measure working memory. We used raw scores for analyses. These are the largest number of digits the participant could remember and repeat in reverse order. Possible range of scores is from zero to 10. Normal persons typically remember from 5 to 7 digits. Higher scores are considered better. Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, helper T cell count, and log viral load as covariates.
Time frame: 3 weeks
Population: All participants who completed treatment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Training | Working Memory: Participants' Rate of Improvement | 6.61 units on a scale | Standard Error 0.62 |
| Cognitive Training With tDCS | Working Memory: Participants' Rate of Improvement | 7.45 units on a scale | Standard Error 0.62 |
Comparison: Analysis results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, cluster of differentiation (CD4) cell count, and log viral load as covariates.p-value: 0.02ANCOVA
Secondary
Center for Epidemiological Studies Depression Scale (CES-D)
Participants' mood over the course of the study. We used the Center for Epidemiological Studies--Depression scale (CES-D) to measure mood. This measure includes 20 items that ask the person assessed to report his or her experience of mood symptoms over the past two weeks. Participants completed this measure before and after the study intervention. Scores can range from zero to 60, with most persons attaining a score of 15 or less. Higher scores are considered worse as they indicate more frequent or more severe mood symptoms.
Time frame: 3 weeks
Population: All participants who completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Training | Center for Epidemiological Studies Depression Scale (CES-D) | 12.95 units on a scale | Standard Error 6.21 |
| Cognitive Training With tDCS | Center for Epidemiological Studies Depression Scale (CES-D) | 23.37 units on a scale | Standard Error 5.1 |
Comparison: Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.p-value: 0.34ANCOVA
Secondary
Patient's Own Assessment of Function (PAOF)
Patient report of cognitive difficulties on the Patient Assessment of Own Functioning. This scale comprises 33 items describing problems in thinking, language, and memory. Participants rate each items according to how often they experience each problem on a six-point scale from almost never (score of 0) to almost always (score of 5). The participant's score is the sum of ratings on all items. The range of possible scores on each item is from 0 to 5, with most persons achieving a score of 1.5 or lower. Higher scores represent more frequent report of cognitive difficulties and thus are considered worse. The range of all possible scores for the full scale of 33 items is is 0 to 165.
Time frame: 3 weeks
Population: All participants who completed training.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Training | Patient's Own Assessment of Function (PAOF) | 7.39 Score on a scale | Standard Error 0.73 |
| Cognitive Training With tDCS | Patient's Own Assessment of Function (PAOF) | 9.17 Score on a scale | Standard Error 0.73 |
Comparison: Results are overall estimated marginal means from repeated measures analysis of covariance with treatment group as a fixed factor and age, gender, race, education, CD4 count, and log viral load as covariates.p-value: 0.33ANCOVA