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

Primary Purpose

Frontotemporal Dementia, Right Sided Cerebral Hemisphere Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain HQ
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frontotemporal Dementia focused on measuring Treatment, Social-Cognitive Training, Web-based, Right Hemisphere Stroke, Frontotemporal Dementia, Right Sided Cerebral Hemisphere Cerebrovascular Accident

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control then Social Cognitive Training

Social Cognitive Training then Control

Arm Description

Patients assigned to this arm will first receive a control therapy on a laptop followed by the Brain HQ social-cognitive training.

Patients assigned to this arm will first receive the Brain HQ social-cognitive training and then undergo a control therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 20, 2015
Last Updated
February 18, 2019
Sponsor
Johns Hopkins University
Collaborators
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02506036
Brief Title
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

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control then Social Cognitive Training
Arm Type
Active Comparator
Arm Description
Patients assigned to this arm will first receive a control therapy on a laptop followed by the Brain HQ social-cognitive training.
Arm Title
Social Cognitive Training then Control
Arm Type
Experimental
Arm Description
Patients assigned to this arm will first receive the Brain HQ social-cognitive training and then undergo a control therapy.
Intervention Type
Other
Intervention Name(s)
Brain HQ
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Social-Cognitive Functioning
Description
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.
Time Frame
Baseline, after intervention (4 - 6 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Argye Hillis, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hosptial
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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