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

NCT02506036 | Completed Results

• 1 other identifier: IRB00061812
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Control then Social Cognitive Training

ACTIVE COMPARATOR

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

Social Cognitive Training then Control

EXPERIMENTAL

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

Other: Brain HQ

Interventions

Brain HQ OTHER

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.

Control then Social Cognitive Training; Social Cognitive Training then Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Johns Hopkins Hosptial

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Frontotemporal Dementia

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

This was a small scale feasibility study mainly designed to determine how this kind of computerized treatment can be tailored for patients with either frontotemporal dementia or right hemisphere stroke. Further trials will be needed to test efficacy.

Results Point of Contact

• Title: Dr. Argye Hillis
• Organization: Johns Hopkins University School of Medicine

argye@jhmi.edu

410-614-2381

Study Officials

• Argye Hillis, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: July 22, 2015
• Study Start: August 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 31, 2019
• Results First Posted: May 31, 2019

Record last verified: 2019-02

Locations

US (1)