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

NCT02596906 | Completed Results FDA Device

• 1 other identifier: CBH-MCI-tDCS
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Regional Brain Blood Flow Change Immediately After 1 Month of Cognitive Training and tDCS Brain Stimulation

  Two longitudinal measurements at baseline and 1-month

Study Arms (2)

tDCS+Training

EXPERIMENTAL

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

Device: tDCS

Sham tDCS+training

SHAM COMPARATOR

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

Interventions

tDCS 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.

tDCS+Training

Sham tDCS 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.

Sham tDCS+training

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age
• Comprehend simple instructions, perform tasks, and take part in intervention

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

UTD Center for BrainHealth

Dallas, Texas, 75235, United States

Location

Related 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.

  PMID: 26022770 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Limitations and Caveats

Participant enrollment was limited due to constraints on time and funding sources.

Results Point of Contact

• Title: Dr. Namrata Das
• Organization: Center for BrainHealth, The university of Texas at Dallas

Namrata.Das@utdallas.edu

9728833266

Study Officials

• Sandra Chapman, PhD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for BrainHealth

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 4, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: October 30, 2023
• Results First Posted: December 11, 2020

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)