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| ID | Type | Description | Link |
|---|---|---|---|
| UAB CAS | Other Identifier | UAB CAS |
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| Name | Class |
|---|---|
| UAB College of Arts and Sciences & Department of Psychology | UNKNOWN |
| Posit Science Corporation | INDUSTRY |
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The purpose of this study is to compare two approaches to cognitive rehabilitation in adults with post-viral cognitive syndrome, which resulted in brain fog. All participants will be screened for eligibility prior to participation. Most of the procedures will take place over a phone call or secure telehealth platform (i.e., Zoom). However, participants will be asked to visit UAB on three occasions for blood sample collection and brain imaging (about 2 hours each). Online testing will happen one month before treatment, one day before treatment, one day afterwards, and 6 months afterwards. The study will utilize two different forms of rehabilitation training to improve participants' cognitive ability. Participants will be randomized to one of the two treatment groups. The first treatment approach, known as Constraint-Induced Cognitive Therapy (CICT), will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) online training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation, also known as trans-auricular VNS (taVNS). The second approach, known as Brain Fitness Training (BFT), will include (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, breathing, healthy nutrition, and healthy sleep, (C) education about how relaxation, breathing, nutrition, and sleep are connected to thinking effectiveness, and (D) taVNS. Approximately 30 hours of training will be conducted over a secure telehealth platform (i.e., Zoom) in the span of two- to four- weeks. A typical CICT session will consist of one hour of gaming, with the bulk of the session being spent on cognitive training of the target behaviors and procedures designed to promote transfer of therapeutic gains to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. A typical BFT session will consist of one hour of gaming, training on healthy lifestyle behaviors (i.e., healthy sleep, nutrition, and relaxation habits), as well as procedures designed to promote transfer of behavior changes to daily life. Ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. Training sessions in both conditions will be scheduled based on participants' availability, with the options for sessions scheduled to be as close as every weekday over 2 weeks or as loosely as every other weekday (i.e., over a 4-week span). If a caregiver is available, they will receive training on how to best support participants in their therapeutic program. After the training ends, both groups will receive 4 follow-up phone calls approximately one week apart to promote integration of the gained skills into everyday life. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CICT + taVNS | Experimental | Constraint-Induced Cognitive Therapy uses in-lab training on everyday activities with important cognitive components, along with the procedures designed to transfer improvements from the treatment setting to everyday life. This will be combined with computer-based processing speed training and non-invasive vagus nerve stimulation. |
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| BFT + taVNS | Active Comparator | Brain Fitness Training involves in-lab training on relaxation, healthy nutrition, and healthy sleep with procedures designed to promote integration of these lifestyles into everyday life. This will be combined with computer-based reaction time training and non-invasive vagus nerve stimulation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Processing Speed Training | Behavioral | Speed of processing training involves trainer-guided practice of computer-based video "games." The games require the "player" to rapidly distinguish targets from decoys, which trains the player to process information from their senses quickly. |
| Measure | Description | Time Frame |
|---|---|---|
| Canadian Occupational Performance Measure (COPM) | The COPM is a standard, validated, trans-diagnostic, patient-centered structured interview commonly used to measure the real-world outcome of rehabilitation procedures that span both motor and cognitive functions after stroke. The Performance Scale assesses how well a participant performs five activities in their daily life, i.e., outside the lab, that are important to the participant. Activities, for this purpose, will be restricted to those with an important cognitive component ,i.e., IADL. The 10-point response scale ranges from 1 (not able to do the activity at all) to 10 (able to do the activity extremely well). Performance Scale scores from the participant will be the primary outcome. | Change from Day 30 to Day 60 (i.e., change from Pre- to Post-treatment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natalie Greig, BS | Contact | 205-934-9768 | nggreig@uab.edu | |
| Helen Bliss, BS | Contact | 205-934-0433 | stacemc@uab.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gitendra Uswatte, PhD | Professor of Psychology, University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
We will share baseline, post-treatment, and follow-up scores on the primary outcome on a de-identified basis.
The IPD will be published along with the primary outcome paper as a supplement. The primary outcome paper will describe the study protocol and the statistical analysis plan. We estimate this will take place within two years of the collection of the last data follow-up data point. The data will be available for as long the journal in which the paper appears exists.
Anyone who can access the journal article will be able to access the supplemental data. As noted, we will post scores on the primary outcome on a de-identified basis. Interested parties will be able to access the data by going to the journal website, finding the article, and then downloading the supplement.
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| In-session Instrumental Activities of Daily Living Training | Behavioral | Participants will receive shaping on IADLs. Participants will receive training on everyday tasks with important cognitive components, in which the difficulty is increased in small steps over the course of treatment. |
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| Transfer Package | Behavioral | The Transfer Package was designed to try to bridge the gap between what is trained in-session and what the participant does outside of treatment sessions. These components include negotiation of a behavioral contract with participants at the outset of treatment regarding the responsibilities of the participant, family caregivers, if available, and the treatment team, self-monitoring, assignment of "homework," review of homework by the trainer, and support of problem-solving by the participant. |
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| Follow Up Phone Calls | Behavioral | After completing training, participants will receive four weekly follow-up phone calls in the first month of training. The focus of the calls will incorporate the lessons learnt during treatment into daily life. |
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| Trans-auricular Vagus Nerve Stimulation: High Intensity | Procedure | The vagus nerve runs from the brain to the external ear, throat, chest, and abdomen and controls, among other functions, the rest and relax response, which supports learning and turns down inflammatory processes. The rest-and-relax response can be activated by electrically stimulating the vagus nerve. We will place electrodes on the external part of each ear and safely apply a microcurrent of at least 4 milliamps. Stimulation will be administered for 10 minutes near the start and midway point of each treatment session. |
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| In-session Brain Health Training | Behavioral | Participants will receive training on healthy eating, sleeping, and relaxation techniques that have been shown to improve brain health. |
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| Reaction Time Training | Behavioral | Reaction time training involves trainer-guided practice of computer-based video "games." Several different games will be featured that train how rapidly "players" react to "threats" and train eye-hand coordination. |
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| Trans-auricular Vagus Nerve Stimulation: Low Intensity | Procedure | The vagus nerve run from the brain to the external ear, throat, chest, and abdomen and controls, among other functions, the rest and relax response, which supports learning and turns down inflammatory processes. The rest and relax response can be turned on by electrically stimulating the vagus nerve. We will place electrodes on the external part of each ear and safely apply a microcurrent of less than 4 milliamps. Stimulation will administered for 10 minutes near the start and midway point of each treatment session. |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| D005222 | Mental Fatigue |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005221 | Fatigue |
| D012816 | Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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