Brain and Cognitive Changes After Reasoning Training in Individuals With Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Brain and Cognitive Changes After Reasoning Training in Individuals With Cognitive Complaints

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596906
• Other study ID #: CBH-MCI-tDCS
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: October 2023
• Source: The University of Texas at Dallas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 stimulation (tDCS) on frontal- lobe mediated cognitive measures of executive control in adults with memory complaints, in the absence of dementia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United States	UTD Center for BrainHealth	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas at Dallas

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to 4 weeks and 3 months post-training
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.	Two longitudinal measurements at baseline and 1-month