Trial Outcomes & Findings for Efficacy of Web-Based Social-Cognitive Interventions in Right Hemisphere Stroke and Frontotemporal Dementia (NCT NCT02506036)
NCT ID: NCT02506036
Last Updated: 2019-05-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Baseline, after intervention (4 - 6 weeks)
Results posted on
2019-05-31
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention (4-6 Weeks)
STARTED
|
3
|
3
|
|
First Intervention (4-6 Weeks)
COMPLETED
|
2
|
1
|
|
First Intervention (4-6 Weeks)
NOT COMPLETED
|
1
|
2
|
|
Washout (1-2 Weeks)
STARTED
|
2
|
1
|
|
Washout (1-2 Weeks)
COMPLETED
|
2
|
1
|
|
Washout (1-2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (4-6 Weeks)
STARTED
|
2
|
1
|
|
Second Intervention (4-6 Weeks)
COMPLETED
|
2
|
1
|
|
Second Intervention (4-6 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
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
Efficacy of Web-Based Social-Cognitive Interventions in Right Hemisphere Stroke and Frontotemporal Dementia
Baseline characteristics by cohort
| Measure |
Control Then Social Cognitive Training
n=3 Participants
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.
|
Social Cognitive Training Then Control
n=3 Participants
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.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
66.7 years
n=5 Participants
|
67.3 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Number of Stars Missed On Star Cancellation Test
|
1 Number of Stars Not Cancelled
n=5 Participants
|
1 Number of Stars Not Cancelled
n=7 Participants
|
1 Number of Stars Not Cancelled
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Social Cognitive Training
n=3 Participants
This is a combined group of all patients who completed social cognitive training during the study regardless of whether they completed the control condition first or second. The scores reported were taken before and immediately after completion of the training intervention specifically.
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.
|
Control
n=3 Participants
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.
|
|---|---|---|
|
Change in Social-Cognitive Functioning
Facial Emotion Recognition At Baseline
|
34.6 Number Correct
Interval 34.0 to 36.0
|
34.6 Number Correct
Interval 34.0 to 36.0
|
|
Change in Social-Cognitive Functioning
Facial Emotion Recognition After Intervention
|
35.3 Number Correct
Interval 34.0 to 38.0
|
34.6 Number Correct
Interval 34.0 to 36.0
|
Adverse Events
Social Cognitive Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Argye Hillis
Johns Hopkins University School of Medicine
Phone: 410-614-2381
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place