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Trial record 6 of 38 for:    neurology AND university of california, san francisco | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Johns Hopkins University
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Argye Beth Hillis, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02506036
First received: July 20, 2015
Last updated: April 7, 2016
Last verified: April 2016
  Purpose
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).

Condition Intervention
Frontotemporal Dementia
Right Sided Cerebral Hemisphere Cerebrovascular Accident
Other: Brain HQ

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Web-Based Social-Cognitive Interventions in Right Hemisphere Stroke and Frontotemporal Dementia

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Change in Social-Cognitive Functioning from Baseline to 12 weeks [ Time Frame: Baseline and 12 weeks ]
    Participants will be given a comprehensive social-cognitive assessment battery that evaluates multiple areas of social-emotional ability and functioning.


Estimated Enrollment: 50
Study Start Date: August 2015
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02506036

Contacts
Contact: Charltien Long clong30@jhmi.edu
Contact: Argye Hillis, MD 410-614-2381 argye@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hosptial Recruiting
Baltimore, Maryland, United States, 21287
Contact: Charltien Long    410-502-6045    clong30@jhmi.edu   
Principal Investigator: Argye Hillis, MD         
Sponsors and Collaborators
Johns Hopkins University
University of California, San Francisco
Investigators
Principal Investigator: Argye Hillis, MD Johns Hopkins School of Medicine
  More Information

Responsible Party: Argye Beth Hillis, Professor of Neurology, Physical Medicine & Rehabilitation, and Cognitive Science, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02506036     History of Changes
Other Study ID Numbers: IRB00061812 
Study First Received: July 20, 2015
Last Updated: April 7, 2016

Keywords provided by Johns Hopkins University:
Treatment
Social-Cognitive Training
Web-based
Right Hemisphere Stroke
Frontotemporal Dementia
Right Sided Cerebral Hemisphere Cerebrovascular Accident

Additional relevant MeSH terms:
Dementia
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Stroke
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 20, 2017