Efficacy of Web-Based Social-Cognitive Interventions in Right Hemisphere Stroke and Frontotemporal Dementia

Frontotemporal Dementia Clinical Trial

Official title:

Efficacy of Web-Based Social-Cognitive Interventions in Right Hemisphere Stroke and Frontotemporal Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506036
• Other study ID #: IRB00061812
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: May 2017

Study information

• Verified date: February 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain
• Right Sided Cerebral Hemisphere Cerebrovascular Accident
• Stroke

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Hosptial	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline, after intervention (4 - 6 weeks)