Migraine DisordersNCT03662295
Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention
An observational study of Migraine Disorders and Aphasia, run by Quality Living, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Migraine Disorders, Aphasia
- What is being tested?
- Language treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2018to 13 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Migraine Disorders, Aphasia
- Being tested
- Language treatment
- Keywords
- Cognitive Impairment
- Medical subject headings
- Migraine Disorders, Aphasia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language treatmentBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized assessment
Aphasia Quotient of the Western Aphasia Battery - Revised
Measured: Change from baseline at 6 months
Secondary outcomes (2)
Spoken picture description
Spoken language sample elicited through a request to describe events depicted in a Norman Rockwell drawing.
Measured: Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks
Written picture description
Written language sample elicited through a request to write about events depicted in a Norman Rockwell drawing.
Measured: Change from baseline at 6 weeks, 10 weeks, 14 weeks, 20 weeks, and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start3 Sep 2018
- Primary completion13 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quality Living, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Hux, Quality Living, Inc.
- Investigators
- Karen Hux, Ph.D., Principal investigator, Quality Living, Inc., Omaha, Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662295
- Sponsor's protocol ID
- SMART
- Status last verified
- Mar 2021
- First submitted
- 3 Sep 2018
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke-like Migraine Attacks After Radiation Treatment (SMART) Syndrome Language Intervention
- ClinicalTrials.gov ID
- NCT03662295
- Acronym / sponsor ID
- SMART
- Conditions
- Migraine Disorders, Aphasia
- Keywords
- Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Quality Living, Inc.University, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 13 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Language treatmentIndividual 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. | Behavioural | – |
Primary outcome
Standardized assessment
Time frame: Change from baseline at 6 months
Aphasia Quotient of the Western Aphasia Battery - Revised
2 secondary outcomes
Spoken picture description
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Hux, Ph.D. principal investigator
Quality Living, Inc., Omaha, Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders and Aphasia, run by Quality Living, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized assessment (time frame: Change from baseline at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.