Clinical trial NCT02596906: Brain and Cognitive Changes After Reasoning Training in Individuals With Mild Cognitive Impairment
Official title: Brain and Cognitive Changes After Reasoning Training in Individuals With Cognitive Complaints
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in California Verbal Learning Task Score
timeFrame: Baseline to 4 weeks and 3 months post-training
Secondary outcomes:
measure: Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation
timeFrame: Two longitudinal measurements at baseline and 1-month
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UTD Center for BrainHealth
state: Texas
Study officials:
affiliation: The University of Texas at Dallas
name: Sandra Chapman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.