Neuroplasticity-Based Cognitive Remediation for Chemotherapy-Related Cognitive Impairment

NCT04230863 | Completed

• 1 other identifier: 191394
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI).

Conditions

Cancer Survivors; Chemotherapy-related Cognitive Impairment

Keywords

Chemotherapy; Cognitive Impairment; neuroplasticity-based computerized cognitive remediation; nCCR

Outcome Measures

Primary Outcomes (3)

• Evaluate completion rates of nCCR

  Assess the percentage of enrolled participants who completed of the 40-hour nCCR treatment

  2 years

• Evaluate visit frequency throughout nCCR treatment

  Assess the frequency of visits during nCCR treatment

  through study completion, an average of 5 weeks.

• Evaluate visit duration throughout nCCR treatment

  Assess the duration of visits during nCCR treatment

  through study completion, an average of 5 weeks.

Study Arms (1)

Neuroplasticity-based Computerized Cognitive Remediation

EXPERIMENTAL

Participants will receive a 45-hour of Neuroplasticity-based Computerized Cognitive Remediation.

Behavioral: Neuroplasticity-based Computerized Cognitive Remediation

Interventions

Neuroplasticity-based Computerized Cognitive Remediation BEHAVIORAL

The nCCR has two major components: Bottom up and Top down training. "Bottom up" training: The training includes selected tasks from "Brain HQ", a program designed for older adults, that enhances basic processing of sensory stimuli with the goal to improve fidelity of auditory and visual encoding. "Top down training": We designed programs to target cognitive control functions associated with poor treatment response, i.e., initiation and use of verbal strategy and susceptibility to interference. These "Top Down" Programs include a visual attention program, either Catch the Ball or Neurogrow, and a semantic strategy program, Semantic Organization.

Neuroplasticity-based Computerized Cognitive Remediation

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants will:
• Be between 35 and 80 years of age,
• Have been diagnosed with noninvasive or invasive (Stage 1, 2, or 3A) breast cancer, colon cancer, lymphoma, endometrial cancer or ovarian cancer
• Have undergone treatment with systemic chemotherapy within the last 1-8 years,
• Endorse persistent CRCI subjective complaints (as defined below),
• Have no active cardiac, neurologic, or psychiatric illness,
• Fluent in and able to read English.

You may not qualify if:

• Participants will be excluded for:
• Any active neurologic psychiatric disease, clinically significant cognitive impairment or dementia, history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities,
• Current major depression or another major psychiatric disorder as described in DSM-5 (use of CNS active medications (e.g. antidepressants) will be permitted, provided dosing has been stable for at least 3 months),
• Any history of alcohol or substance abuse or dependence within the past 2 years (DSM-5 criteria),
• Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol.
• Use of any investigational drugs within 30 days or 5 half-lives, whichever is longer, prior to screening, and
• Use of cholinergic agents will be discouraged but will be reviewed on a case-by-case basis by the PI.
• Red-green color blindness. Other types of color blindness will be reviewed on a case-by-case basis by the PI.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• University of Utah: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Chemotherapy-Related Cognitive Impairment; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Paul A Newhouse, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Principal Investigator

Model Details: A single-arm, open label design; All analyses are pre-post, with participants serving as their own controls.

Study Record Dates

• First Submitted: January 10, 2020
• First Posted: January 18, 2020
• Study Start: February 17, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)