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

NCT ID: NCT02596906

Last Updated: 2023-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

tDCS+Training

This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks

Group Type: EXPERIMENTAL

tDCS

Intervention Type: DEVICE

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+training

This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.

Group Type: SHAM_COMPARATOR

Sham tDCS

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The University of Texas at Dallas

OTHER

Sponsor Role: lead

Responsible Party

Sandra Chapman, PhD

Director, Center for BrainHealth

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra Chapman, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas at Dallas

Locations

UTD Center for BrainHealth

Dallas, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26022770 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CBH-MCI-tDCS

Identifier Type: -

Identifier Source: org_study_id