NCT03662295

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2019

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

September 3, 2018

Last Update Submit

March 9, 2021

Conditions

Keywords

Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Standardized assessment

    Aphasia Quotient of the Western Aphasia Battery - Revised

    Change from baseline at 6 months

Secondary Outcomes (2)

  • Spoken picture description

    Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks

  • Written picture description

    Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks

Interventions

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.

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quality Living, Inc.

Omaha, Nebraska, 68104, United States

Location

MeSH Terms

Conditions

Migraine DisordersAphasiaCognitive Dysfunction

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Karen Hux, Ph.D.

    Quality Living, Inc., Omaha, Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Research

Study Record Dates

First Submitted

September 3, 2018

First Posted

September 7, 2018

Study Start

September 3, 2018

Primary Completion

November 13, 2019

Study Completion

November 13, 2019

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations