Brain and Cognitive Changes After Reasoning Training in Individuals With Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sham tDCS
Sponsored by

About this trial
This is an interventional treatment trial for Mild Cognitive Impairment
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
Sites / Locations
- UTD Center for BrainHealth
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
tDCS+Training
Sham tDCS+training
Arm Description
This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks
This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02596906
First Posted
October 30, 2015
Last Updated
December 10, 2020
Sponsor
The University of Texas at Dallas
1. Study Identification
Unique Protocol Identification Number
NCT02596906
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas at Dallas
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tDCS+Training
Arm Type
Experimental
Arm Description
This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks
Arm Title
Sham tDCS+training
Arm Type
Sham Comparator
Arm Description
This group will receive 20 minutes of "sham" tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
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
Intervention Name(s)
Sham tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in California Verbal Learning Task Score
Description
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
Secondary Outcome Measure Information:
Title
Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Chapman, PhD
Organizational Affiliation
The University of Texas at Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTD Center for BrainHealth
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26022770
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.
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Brain and Cognitive Changes After Reasoning Training in Individuals With Mild Cognitive Impairment
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