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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03662295
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
Karen Hux, Quality Living, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Migraine Disorders Aphasia Behavioral: Language treatment

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Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention
Actual Study Start Date : September 3, 2018
Actual Primary Completion Date : November 13, 2019
Actual Study Completion Date : November 13, 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Aphasia Migraine


Intervention Details:
  • Behavioral: Language treatment
    Individual speech-language therapy sessions totaling 1.5 to 2.5 hours five days per week. Intervention activities include performing oral and written confrontation and responsive naming, writing single words to dictation, reading single words and sentences aloud, and generating written and spoken picture descriptions.


Primary Outcome Measures :
  1. Standardized assessment [ Time Frame: Change from baseline at 6 months ]
    Aphasia Quotient of the Western Aphasia Battery - Revised


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes 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.
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03662295


Locations
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United States, Nebraska
Quality Living, Inc.
Omaha, Nebraska, United States, 68104
Sponsors and Collaborators
Quality Living, Inc.
Investigators
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Principal Investigator: Karen Hux, Ph.D. Quality Living, Inc., Omaha, Nebraska
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Responsible Party: Karen Hux, Director of Research, Quality Living, Inc.
ClinicalTrials.gov Identifier: NCT03662295    
Other Study ID Numbers: QualityLiving
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Hux, Quality Living, Inc.:
Cognitive Impairment
Additional relevant MeSH terms:
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Migraine Disorders
Aphasia
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations