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

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ClinicalTrials.gov Identifier: NCT02596906
Recruitment Status : Completed
First Posted : November 4, 2015
Results First Posted : December 11, 2020
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Sandra Chapman, PhD, The University of Texas at Dallas

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Device: tDCS Device: Sham tDCS Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Brain and Cognitive Changes After Reasoning Training in Individuals With Cognitive Complaints
Study Start Date : January 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: tDCS+Training
This group will receive 20 minutes of tDCS, 8x over four weeks immediately followed by reasoning training 8x over four weeks
 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 Comparator: 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in California Verbal Learning Task Score [ Time Frame: Baseline to 4 weeks and 3 months post-training ]

    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 :
  1. Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation [ Time Frame: Two longitudinal measurements at baseline and 1-month ]
    Non-invasive estimation of rCBF by perfusion maps using pseudo-continuous arterial spin labeling (pCASL) MRI. rCBF is quantified as mL/min/100g tissue.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596906


Locations
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United States, Texas
UTD Center for BrainHealth
Dallas, Texas, United States, 75235
Sponsors and Collaborators
The University of Texas at Dallas
Investigators
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Principal Investigator: Sandra Chapman, PhD The University of Texas at Dallas
  Study Documents (Full-Text)

Documents provided by Sandra Chapman, PhD, The University of Texas at Dallas:
Study Protocol and Statistical Analysis Plan  [PDF] July 10, 2017

More Information
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Publications:

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Responsible Party: Sandra Chapman, PhD, Director, Center for BrainHealth, The University of Texas at Dallas
ClinicalTrials.gov Identifier: NCT02596906    
Other Study ID Numbers: CBH-MCI-tDCS
First Posted: November 4, 2015    Key Record Dates
Results First Posted: December 11, 2020
Last Update Posted: January 7, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders