Effect of Computerized Cognitive Training in Persons With MS

NCT05345288 | Completed

• 1 other identifier: 0112-22-EP
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple sclerosis (MS) affects approximately one million people in the United States and 2.5 million worldwide. Between one million and 1.75 million persons with MS (PwMS) worldwide are estimated to suffer from cognitive impairment. Unfortunately, there is currently no consensus on the best treatment for cognitive impairment in PwMS. The objective for this study is to determine if a computerized cognitive training using the BrainHQ platform can improve cognitive impairment in PwMS. The central hypothesis is that computerized cognitive training will show some improvement in cognitive impairment. The rationale for this study is to treat all aspects of MS, not just the physical symptoms and to help PwMS live their best life. Cognitive impairment is associated with higher rates of depression in PwMS and depression leads to medication non-adherence. This means the cognitive impairment so many PwMS are dealing with must be treated. Finding non-pharmacological interventions to mitigate cognitive declines are essential to ensure that quality of life for PwMS patients matches our ability to treat and mitigate their physical symptoms of MS. To obtain the overall objectives for this study the following specific aim will be pursued: Determine the effectiveness of computerized cognitive training on changes in cognitive impairment for PwMS. This will be accomplished by completing a randomized clinical trial with two groups: computerized cognitive training using BrainHQ and an active control group that will complete non-cognitive training programs on BrainHQ. Subjects will complete the BICAMS battery at baseline and at the end of their six week intervention. Subjects will be prescribed online activities through BrainHQ to complete 2-3 times a week for approximately 20-30 minutes each. Subjects will also be asked to wear an accelerometer for a week to determine if physical activity affects cognition. The proposed research is significant because MS is diagnosed on average at age 30, meaning a high percentage of the PwMS that are suffering with cognitive impairment are in their second, third and fourth decade when they are trying to raise a family, finish college, further their career and have active social lives.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (1)

• Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery

  score change in the 3 tests that make up the BICAMS battery - Symbol Digits Modalities Test (SDMT), California Verbal Learning Test 2nd Edition (CVLT-II), Brief Visuospatial Memory Test-Revised (BVMT-R). On all 3 tests a higher score is better. The tests all have normative values and t- or z-scores to compare. Baseline and post-intervention scores will be compared to see if subjects significantly improved post-intervention.

  at study completion, approximately 3 months

Study Arms (2)

Intervention

EXPERIMENTAL

Subjects randomized to the intervention group will complete prescribed cognitive training activities 3 times a week for 20-30 minutes each time for 6 weeks. Subjects randomized to the control group will complete computerized control activities that are not cognitive training on BrainHQ 3 times a week for 20-30 minutes each time for 6 weeks.

Device: BrainHQ cognitive training

Control

ACTIVE COMPARATOR

Subjects randomized to the control group will complete computerized control activities that are not cognitive training on BrainHQ 3 times a week for 20-30 minutes each time for 6 weeks.

Device: BrainHQ control games

Interventions

BrainHQ cognitive training DEVICE

Posit Science's BrainHQ exercises are based on the science of "neuroplasticity," also called "brain plasticity." Brain plasticity is your brain's natural ability to remodel itself throughout life. The brain is always changing, sometimes for better, and sometimes for worse. What BrainHQ's exercises do is harness that change and direct it in ways that can enhance your overall performance and improve the quality of your life. BrainHQ exercises are grouped into six categories: Attention, Memory, Brain Speed, Intelligence, People Skills, and Navigation.

Also known as: www.brainhq.com

Intervention

BrainHQ control games DEVICE

BrainHQ also offers control games for research studies. The control activities will be games similar to candy crush, connect four, gem swap and battleship.

Also known as: www.brainhq.com

Control

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 19-60 inclusive
• Expanded Disability Status Scale (EDSS) score of 2-5.5 inclusive
• Relapsing-Remitting MS according to McDonald Criteria
• or above on the Montreal Cognitive Assessment (MoCA)
• or above on the Test of Premorbid Functioning (TOPF)
• or less on the Beck Depression Inventory (BDI-II)
• Less than 15 on the Generalized Anxiety Disorder (GAD-7)

You may not qualify if:

• Relapse within the last 6 months
• Disease modifying treatment (DMT) change within the last 6 months
• Primary Progressive MS or Secondary Progressive MS according to McDonald Criteria
• No access to computer/internet
• Currently undergoing treatment for cognitive impairment
• Answers a 2 or 3 on the suicidal thoughts question of the BDI-II
• Answers a 1 on the suicidal thoughts question of the BDI-II and then a Columbia Suicide Severity Rating Scale indicates more than low risk

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related Links

• BrainHQ website which is what the subjects will be using for the intervention and control activities.

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Samantha J Jack, MS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know if there are in the intervention or control group until the completion of the study. The PI will know since she will have to assign the online activities.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention group will complete the prescribed computerized cognitive training while the control group will complete the control games that are not cognitive training and offered through the BrainHQ website as well.

Study Record Dates

• First Submitted: March 20, 2022
• First Posted: April 25, 2022
• Study Start: June 28, 2022
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2022
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)