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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03662295
Other study ID # SMART
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 3, 2018
Est. completion date November 13, 2019

Study information

Verified date March 2021
Source Quality Living, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date November 13, 2019
Est. primary completion date November 13, 2019
Accepts healthy volunteers
Gender All
Age group 19 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Quality Living, Inc. Omaha Nebraska

Sponsors (1)

Lead Sponsor Collaborator
Quality Living, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Standardized assessment Aphasia Quotient of the Western Aphasia Battery - Revised Change from baseline at 6 months
Secondary Spoken picture description 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
Secondary Written picture description 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
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