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

February 18, 2019 updated by: Johns Hopkins University
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).

Study Overview

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

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hosptial

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Argye Hillis, MD, Johns Hopkins School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2015

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

July 20, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (ESTIMATE)

July 22, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 31, 2019

Last Update Submitted That Met QC Criteria

February 18, 2019

Last Verified

February 1, 2019

More Information

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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