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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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This study is being done to test the feasibility and effectiveness of web-based social-cognitive training exercises in treating social-emotional deficits in patients with stroke or frontotemporal dementia (FTD).
Although deficits in empathy and social interaction are relatively common in certain forms of FTD and stroke, there are currently no proven treatments for these symptoms. Spouses and caregivers often cite these symptoms as a major concern, and these deficits can have a negative impact on the quality of life that patients experience. The purpose of this study is to evaluate whether or not web-based social training exercises can improve social-cognitive impairments in patients with FTD or right hemisphere stroke. These training exercises have been shown to improve social skills and empathy in other disorders. This study will be the first to examine if these exercises can be effective and feasible for treating social deficits in stroke and FTD.
The study will be based out of the Johns Hopkins Hospital where patients will be assessed three times in total. Patients will be assessed upon enrollment in the study and after each of the two treatment conditions. The training itself will be completed at home on a provided laptop, with monitoring and support by the study team. This study uses a crossover design, which means that all patients will receive the training treatment and a control treatment during their participation in the study. The approximate timeline for the study is 9 weeks total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control then Social Cognitive Training | Active Comparator | Patients assigned to this arm will first receive a control therapy on a laptop followed by the Brain HQ social-cognitive training. |
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| Social Cognitive Training then Control | Experimental | Patients assigned to this arm will first receive the Brain HQ social-cognitive training and then undergo a control therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain HQ | Other | Brain HQ is a web application that will be used to provide patients with a training intervention that addresses deficits in social-emotional functions. These include areas such as identifying facial expression, understanding tone of voice, and predicting how people may react in certain situations. The training will take about 30 hours over the course of 4-6 weeks and is done at home. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Social-Cognitive Functioning | Participants will be administered a test of facial emotion recognition called the Penn Emotion recognition task (Range of Scores: 0-40). Participants are shown a face and asked to identify the emotion the face displays, if any. The score reflects the number of faces where the emotion is correctly identified. A score of 35 means that the emotions of 35 out of the 40 faces was correctly identified. | Baseline, after intervention (4 - 6 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Argye Hillis, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hosptial | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Then Social Cognitive Training | Patients assigned to this arm will first receive a control therapy on a laptop followed by the Brain HQ social-cognitive training. Brain HQ: Brain HQ is a web application that will be used to provide patients with a training intervention that addresses deficits in social-emotional functions. These include areas such as identifying facial expression, understanding tone of voice, and predicting how people may react in certain situations. The training will take about 30 hours over the course of 4-6 weeks and is done at home. |
| FG001 | Social Cognitive Training Then Control | Patients assigned to this arm will first receive the Brain HQ social-cognitive training and then undergo a control therapy. Brain HQ: Brain HQ is a web application that will be used to provide patients with a training intervention that addresses deficits in social-emotional functions. These include areas such as identifying facial expression, understanding tone of voice, and predicting how people may react in certain situations. The training will take about 30 hours over the course of 4-6 weeks and is done at home. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (4-6 Weeks) |
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| Washout (1-2 Weeks) |
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| Second Intervention (4-6 Weeks) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Then Social Cognitive Training | Patients assigned to this arm will first receive a control therapy on a laptop followed by the Brain HQ social-cognitive training. Brain HQ: Brain HQ is a web application that will be used to provide patients with a training intervention that addresses deficits in social-emotional functions. These include areas such as identifying facial expression, understanding tone of voice, and predicting how people may react in certain situations. The training will take about 30 hours over the course of 4-6 weeks and is done at home. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Social-Cognitive Functioning | Participants will be administered a test of facial emotion recognition called the Penn Emotion recognition task (Range of Scores: 0-40). Participants are shown a face and asked to identify the emotion the face displays, if any. The score reflects the number of faces where the emotion is correctly identified. A score of 35 means that the emotions of 35 out of the 40 faces was correctly identified. | Posted | Mean | Full Range | Number Correct | Baseline, after intervention (4 - 6 weeks) |
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Adverse event data was collected over the course of participation in the study, which on average was between 12-14 weeks dependent on patient availability for testing.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Social Cognitive Training | This is a combined group of all patients who received social cognitive training during the study regardless of whether they completed the control condition first or second. This includes patients who did not finish the training but started it. Brain HQ: Brain HQ is a web application that will be used to provide patients with a training intervention that addresses deficits in social-emotional functions. These include areas such as identifying facial expression, understanding tone of voice, and predicting how people may react in certain situations. The training will take about 30 hours over the course of 4-6 weeks and is done at home. |
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This was a small scale feasibility study mainly designed to determine how this kind of computerized treatment can be tailored for patients with either frontotemporal dementia or right hemisphere stroke. Further trials will be needed to test efficacy.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Argye Hillis | Johns Hopkins University School of Medicine | 410-614-2381 | argye@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2015 | Aug 6, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D057180 | Frontotemporal Dementia |
| ID | Term |
|---|---|
| D057174 | Frontotemporal Lobar Degeneration |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Withdrawal by Subject |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Social Cognitive Training Then Control | Patients assigned to this arm will first receive the Brain HQ social-cognitive training and then undergo a control therapy. Brain HQ: Brain HQ is a web application that will be used to provide patients with a training intervention that addresses deficits in social-emotional functions. These include areas such as identifying facial expression, understanding tone of voice, and predicting how people may react in certain situations. The training will take about 30 hours over the course of 4-6 weeks and is done at home. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Number of Stars Missed On Star Cancellation Test | Participants circle every star on a page, in which stars are intermixed with other figures. There are a total of 54 stars. The score is the number of stars that the participant failed to circle. A low number of stars missed (eg. 1 or 2 out of a total of 54) indicates no major visual impairment given then they were able to see and circle almost all of the stars. | Median | Full Range | Number of Stars Not Cancelled |
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| OG001 | Control | This is a combined group of all patients who received the control condition and who completed all testing. The scores reported were taken before and immediately after completion of the control portion specifically. Control: Participants were given an comparable amount (35 hours) of audiobooks to listen to at home over a 4-6 week period. |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Control | This is a combined group of all patients who received the control condition during the study. This includes patients who did not finish the control condition but started it. Control: Participants were given an comparable amount (35 hours) of audiobooks to listen to at home over a 4-6 week period. | 1 | 4 | 0 | 4 | 0 | 4 |
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| D009422 | Nervous System Diseases |
| D057177 | TDP-43 Proteinopathies |
| D019636 | Neurodegenerative Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |