Clinical trial NCT02506036: Efficacy of Web-Based Social-Cognitive Interventions in Right Hemisphere Stroke and Frontotemporal Dementia
Official title: Efficacy of Web-Based Social-Cognitive Interventions in Right Hemisphere Stroke and Frontotemporal Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frontotemporal Dementia
Right Sided Cerebral Hemisphere Cerebrovascular Accident
Keywords: Treatment
Social-Cognitive Training
Web-based
Right Hemisphere Stroke
Frontotemporal Dementia
Right Sided Cerebral Hemisphere Cerebrovascular Accident
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
First posted: 2015-07-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Social-Cognitive Functioning
timeFrame: Baseline, after intervention (4 - 6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hosptial
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Argye Hillis, MD
role: PRINCIPAL_INVESTIGATOR
References: