- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02506036
Efficacy of Web-Based Social-Cognitive Interventions in Right Hemisphere Stroke and Frontotemporal Dementia
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hosptial
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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 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.
|
EXPERIMENTAL: 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 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Social-Cognitive Functioning
Time Frame: 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.
|
Baseline, after intervention (4 - 6 weeks)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Argye Hillis, MD, Johns Hopkins School of Medicine
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Stroke
- Dementia
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
Other Study ID Numbers
- IRB00061812
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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