TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis)NCT03453125
Improving Learning in Hispanics With TBI or MS
A study testing Spanish modified Story Memory Technique (mSMT) in people with TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis), run by Kessler Foundation at 2 sites in 2 countries.
Trial summary
The goal of this study is to establish that a memory retraining protocol, originally developed for English-speakers, and translated into Spanish, is effective. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis)
- What is being tested?
- Spanish modified Story Memory Technique (mSMT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Sep 2013to 30 Sep 2022
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between the ages of 18 and 65
- Spanish is my dominant language, and I have had a traumatic brain injury or I have multiple sclerosis.
Who cannot join
- Participants with major depressive disorder, schizophrenia, bipolar disorder I or II
- MS subjects: Individuals with a history of head injury, stroke, seizures, or any other significant neurological history will not be included in the study.
- TBI subjects: Individuals must have sustained a TBI at least one year prior to enrollment in the study protocol. Individuals with a history of significant neurological insult other than TBI (e.g. premorbid epilepsy, multiple sclerosis, Alzheimer's disease) will not be included in the study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
East Hanover, New Jersey, 07936
Denise Krch, PhD, 973-324-8392, dkrch@kesslerfoundation.org
Belinda Washington, BA, 973-324-8440, bwashington@kesslerfoundation.org
Spain1 site, 1 recruiting
- Recruiting
Hospital Aita Menni
Arrasate / Mondragón
Garazi Labayr Isusquiza, PhD, +34 943794411, glabairu@aita-menni.org
Jose Ignacio, MD, +34 943794411, jiquemada@aita-menni.org
About this study
Official title: Improving Learning in Hispanics With TBI or MS: A Pilot Trial
The goal of this study is to establish that a memory retraining protocol, originally developed for English-speakers, and translated into Spanish, is effective.
Read the detailed description
A pilot study will be conducted to carry out this validation and resolve any methodological concerns in the translated protocol. 20 Spanish-speaking Hispanics at least one year post-traumatic brain injury (TBI) and 20 Spanish-speaking Hispanics with multiple sclerosis (MS), both with an objective deficit in learning and memory will be recruited. Baseline assessment includes neuropsychological evaluation using traditional measures as well as completion of a number of questionnaires designed to measure everyday memory and everyday functioning. Subjects are randomly assigned to either the experimental or control groups. Experimental and control treatments includes two 45-60 minute sessions, twice per week, for 5 weeks. Follow-up assessment includes a neuropsychological evaluation using traditional measures as well as completion of a number of questionnaires designed to measure everyday memory and everyday functioning. Protocol efficacy will be determined by improvements between baseline and follow-up on an objective measure of learning and memory.
- Being tested
- Spanish modified Story Memory Technique (mSMT)
- Keywords
- cognitive rehabilitation, memory
- Medical subject headings
- Brain Injuries, Traumatic, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spanish modified Story Memory Technique (mSMT)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Spanish mSMT Experimental Treatment | Experimental | Administered by computer and paper and pencil. Receives: Behavioral: Spanish modified Story Memory Technique (mSMT) |
| Spanish mSMT Control Treatment | Active comparator | Administered by computer and paper and pencil. Receives: Behavioral: Spanish modified Story Memory Technique (mSMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total learning post-treatment (covarying for baseline performance)
Comparison between treatment and control groups on post-treatment Hopkins Verbal Learning Test (HVLT) learning score, covarying for baseline HVLT performance.
Measured: 7 weeks (between pre- and post testing)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2018
- Study start25 Sep 2013
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Vocacional Enrique Díaz de León A.C., Guadalajara, Mexico
- Responsible party
- Principal investigator, Denise Krch, Kessler Foundation
- Investigators
- Nancy Chiaravalloti, PhD, Study director, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03453125
- Sponsor's protocol ID
- R-799-13
- Status last verified
- Dec 2021
- First submitted
- 21 Feb 2018
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Learning in Hispanics With TBI or MS: A Pilot Trial
- ClinicalTrials.gov ID
- NCT03453125
- Acronym / sponsor ID
- R-799-13
- Keywords
- cognitive rehabilitation, memory
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- Instituto Vocacional Enrique Díaz de León A.C., Guadalajara, Mexico
- Study start
- 25 Sep 2013 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 5 Mar 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.
The goal of this study is to establish that a memory retraining protocol, originally developed for English-speakers, and translated into Spanish, is effective.
Detailed description
A pilot study will be conducted to carry out this validation and resolve any methodological concerns in the translated protocol. 20 Spanish-speaking Hispanics at least one year post-traumatic brain injury (TBI) and 20 Spanish-speaking Hispanics with multiple sclerosis (MS), both with an objective deficit in learning and memory will be recruited. Baseline assessment includes neuropsychological evaluation using traditional measures as well as completion of a number of questionnaires designed to measure everyday memory and everyday functioning. Subjects are randomly assigned to either the experimental or control groups. Experimental and control treatments includes two 45-60 minute sessions, twice per week, for 5 weeks. Follow-up assessment includes a neuropsychological evaluation using traditional measures as well as completion of a number of questionnaires designed to measure everyday memory and everyday functioning. Protocol efficacy will be determined by improvements between baseline and follow-up on an objective measure of learning and memory.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spanish mSMT Experimental Treatment | Experimental | Behavioral: Spanish modified Story Memory Technique (mSMT)Administered by computer and paper and pencil. |
| Spanish mSMT Control Treatment | Active comparator | Behavioral: Spanish modified Story Memory Technique (mSMT)Administered by computer and paper and pencil. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- between the ages of 18 and 65
- Spanish is my dominant language, and I have had a traumatic brain injury or I have multiple sclerosis.
Key exclusion criteria (3 listed)
- Participants with major depressive disorder, schizophrenia, bipolar disorder I or II
- MS subjects: Individuals with a history of head injury, stroke, seizures, or any other significant neurological history will not be included in the study.
- TBI subjects: Individuals must have sustained a TBI at least one year prior to enrollment in the study protocol. Individuals with a history of significant neurological insult other than TBI (e.g. premorbid epilepsy, multiple sclerosis, Alzheimer's disease) will not be included in the study.
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 |
|---|---|---|
| Spanish modified Story Memory Technique (mSMT) | Behavioural | Spanish mSMT Control Treatment, Spanish mSMT Experimental Treatment |
Primary outcome
Total learning post-treatment (covarying for baseline performance)
Time frame: 7 weeks (between pre- and post testing)
Comparison between treatment and control groups on post-treatment Hopkins Verbal Learning Test (HVLT) learning score, covarying for baseline HVLT performance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Individual participant dataSharing planned: Undecided
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.
Nancy Chiaravalloti, PhD study director
Kessler Foundation
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spanish modified Story Memory Technique (mSMT) in people with TBI (Traumatic Brain Injury) or MS (Multiple Sclerosis), run by Kessler Foundation at 2 sites in 2 countries.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Denise Krch, PhD (973-324-8392, dkrch@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total learning post-treatment (covarying for baseline performance) (time frame: 7 weeks (between pre- and post testing)). 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 12 Jan 2022.