Frontotemporal Dementia, Right Sided Cerebral Hemisphere Cerebrovascular Accident
Conditions
Keywords
Treatment, Social-Cognitive Training, Web-based, Right Hemisphere Stroke, Frontotemporal Dementia, Right Sided Cerebral Hemisphere Cerebrovascular Accident
Brief summary
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).
Detailed description
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.
Interventions
OTHERBrain 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.
Sponsors
University of California, San Francisco
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of right hemispheric stroke or behavioral variant frontotemporal dementia. * Able to give informed consent. * Premorbid proficiency in English (by self-report). * Age 18 or older. * Score of 21 or higher on the mini-mental state examination.
Exclusion criteria
* Prior history of neurological disease affecting the brain other than stroke or frontotemporal dementia (e.g., brain tumor, multiple sclerosis, traumatic brain injury) * Known uncorrected hearing loss * Known uncorrected vision loss * Prior history of severe psychiatric illness, developmental disorders, or mental retardation (e.g., schizophrenia, autism spectrum disorders) other than FTD * Score of 20 or lower on the Mini-Mental State Examination.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Social-Cognitive Functioning | Baseline, after intervention (4 - 6 weeks) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| 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. | 3 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (4-6 Weeks) | Death | 1 | 0 |
| First Intervention (4-6 Weeks) | Lost to Follow-up | 0 | 1 |
| First Intervention (4-6 Weeks) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Control Then Social Cognitive Training | Social Cognitive Training Then Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Continuous | 66.7 years | 67.3 years | 67 years |
| Number of Stars Missed On Star Cancellation Test | 1 Number of Stars Not Cancelled | 1 Number of Stars Not Cancelled | 1 Number of Stars Not Cancelled |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 6 Participants |
| Region of Enrollment United States | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 1 / 4 |
| other Total, other adverse events | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 |
Outcome results
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.
Time frame: Baseline, after intervention (4 - 6 weeks)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Social Cognitive Training | Change in Social-Cognitive Functioning | Facial Emotion Recognition After Intervention | 35.3 Number Correct |
| Social Cognitive Training | Change in Social-Cognitive Functioning | Facial Emotion Recognition At Baseline | 34.6 Number Correct |
| Control | Change in Social-Cognitive Functioning | Facial Emotion Recognition At Baseline | 34.6 Number Correct |
| Control | Change in Social-Cognitive Functioning | Facial Emotion Recognition After Intervention | 34.6 Number Correct |