Effect of Computerized Cognitive Training in Persons With MS
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ClinicalTrials.gov Identifier: NCT05345288 |
Recruitment Status :
Completed
First Posted : April 25, 2022
Last Update Posted : September 29, 2023
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Condition or disease | Intervention/treatment | Phase |
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Multiple Sclerosis, Relapsing-Remitting | Device: BrainHQ cognitive training Device: BrainHQ control games | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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. |
Masking: | Single (Participant) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
Official Title: | Effect of Computerized Cognitive Training in Persons With MS |
Actual Study Start Date : | June 28, 2022 |
Actual Primary Completion Date : | October 21, 2022 |
Actual Study Completion Date : | October 21, 2022 |
Arm | Intervention/treatment |
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Experimental: Intervention
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.
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Device: BrainHQ cognitive training
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.
Other Name: www.brainhq.com |
Active Comparator: Control
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.
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Device: BrainHQ control games
BrainHQ also offers control games for research studies. The control activities will be games similar to candy crush, connect four, gem swap and battleship.
Other Name: www.brainhq.com |
- Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) battery [ Time Frame: at study completion, approximately 3 months ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 19 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Ages 19-60 inclusive
- Expanded Disability Status Scale (EDSS) score of 2-5.5 inclusive
- Relapsing-Remitting MS according to McDonald Criteria
- 17 or above on the Montreal Cognitive Assessment (MoCA)
- 70 or above on the Test of Premorbid Functioning (TOPF)
- 29 or less on the Beck Depression Inventory (BDI-II)
- Less than 15 on the Generalized Anxiety Disorder (GAD-7)
Exclusion Criteria:
- 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
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): NCT05345288
United States, Nebraska | |
University of Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 |
Principal Investigator: | Samantha J Jack, MS | University of Nebraska |
Responsible Party: | University of Nebraska |
ClinicalTrials.gov Identifier: | NCT05345288 |
Other Study ID Numbers: |
0112-22-EP |
First Posted: | April 25, 2022 Key Record Dates |
Last Update Posted: | September 29, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |