Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention

March 9, 2021 updated by: Karen Hux, Quality Living, Inc.
Stroke-like migraine attacks after radiation therapy-also known as SMART syndrome-constitute a rare condition typically characterized by headache, seizures, vision abnormalities, hemiparesis, and aphasia. The condition usually resolves within a few days or weeks of onset with no residual impairments. However, resolution in some cases extends over a period of months rather than weeks and may be incomplete. The purpose of this case report is to provide an in-depth description of the progression of changes in cognitive and language functioning for a person exhibiting SMART syndrome characterized by slow recovery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1

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

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68104
        • Quality Living, Inc.

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

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

One adult with SMART syndrome will participate in this study. The person will have cognitive and language deficits typical of those exhibited by people with SMART syndrome. Given the rarity of the disorder, only one participant is anticipated.

Description

Inclusion Criteria:

  • exhibit cognitive and language deficits secondary to SMART syndrome
  • be a former or current client of Quality Living, Inc., Omaha, Nebraska
  • be a native speaker of English

Exclusion Criteria:

-

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized assessment
Time Frame: Change from baseline at 6 months
Aphasia Quotient of the Western Aphasia Battery - Revised
Change from baseline at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spoken picture description
Time Frame: Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks
Spoken language sample elicited through a request to describe events depicted in a Norman Rockwell drawing.
Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks
Written picture description
Time Frame: Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks
Written language sample elicited through a request to write about events depicted in a Norman Rockwell drawing.
Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks

Collaborators and Investigators

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

Sponsor

Quality Living, Inc.

Investigators

  • Principal Investigator: Karen Hux, Ph.D., Quality Living, Inc., Omaha, Nebraska

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)

September 3, 2018

Primary Completion (Actual)

November 13, 2019

Study Completion (Actual)

November 13, 2019

Study Registration Dates

First Submitted

September 3, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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