Traumatic Brain InjuryNCT04056312
Modified Story Memory Technique (mSMT) in Persons With TBI
A study testing Group Memory retraining exercises in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
The current RCT is designed to: 1. test the efficacy of the group based mSMT in persons with TBI on NPE, the current gold-standard for measuring memory functioning 2. assess the effectiveness of the group mSMT on more global measures of everyday life, including an objective measure shown through our previous work to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Group Memory retraining exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2016to 30 Jun 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
- I am between the ages of 18-65.
- I have had a Traumatic Brain Injury at least one year ago.
- I can read and speak English fluently.
- I have difficulties with learning and memory skills.
Who cannot join
- I am currently taking steroids and /or benzodiazepines as determined by study staff review of my medications.
- I have had a prior stroke or neurological injury/disease other than a traumatic brain injury.
- I have a history of significant psychiatric illness (for example, bipolar disorder or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
- I have unstable or uncontrolled seizures.
- I have a significant alcohol or drug abuse history.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial Examining The Efficacy of The Group Administered Modified Story Memory Technique (mSMT) in Persons With TBI
The current RCT is designed to:
- test the efficacy of the group based mSMT in persons with TBI on NPE, the current gold-standard for measuring memory functioning
- assess the effectiveness of the group mSMT on more global measures of everyday life, including an objective measure shown through our previous work to be sensitive to memory changes following the mSMT, as well as additional questionnaires to be completed by both the participant and a significant other
- evaluate the changes in brain functioning following treatment with the mSMT via fMRI and
- evaluate the long-term effects of the treatment protocol.
To accomplish these goals investigators will conduct a double-blind, placebo-controlled, RCT, applying the group mSMT to a sample of 60 participants with moderate to severe TBI (30 treatment; 30 control).
Read the detailed description
Outcome measures will assess objective memory abilities, everyday memory abilities and patterns of cerebral activation during learning. A long-term follow-up assessment will be conducted, designed to measure the impact of the mSMT 3 months following treatment completion. Alternate forms will be utilized wherever available.
- Conditions
- Traumatic Brain Injury
- Being tested
- Group Memory retraining exercises, Placebo controlled group memory exercise training
- Keywords
- memory, learning, cognition, traumatic brain injury, treatment and therapy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Memory retraining exercisesBehavioural
Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.
Placebo controlled group memory exercise trainingBehavioural
Placebo group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.
| Study group | Role | What they receive |
|---|---|---|
| Group memory retraining | Experimental | Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group. Receives: Behavioral: Group Memory retraining exercises |
| Placebo | Placebo comparator | Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group. Receives: Behavioral: Placebo controlled group memory exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
California Verbal Learning Test
Change on scores on memory tests will be assessed using the California Verbal Learning Test
Measured: Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later
The Traumatic Brain Injury-Quality of Life Scale
Self-reports of emotional functioning, memory functioning and quality of life on The Traumatic Brain Injury-Quality of Life Scale, which measures these constructs. DVs will be change on the Depression subscale (range: 0-40; lower score is better) and Cognition scale (range: 0-40; higher score is better).
Measured: Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2019
- Study start29 Jun 2016
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Nancy Chiaravalloti, Kessler Foundation
- Investigators
- Richard Green, PhD, Study chair, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04056312
- Sponsor's protocol ID
- R-926-16
- Other IDs
- AZ150145
- Status last verified
- Jul 2026
- First submitted
- 15 Aug 2017
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Examining The Efficacy of The Group Administered Modified Story Memory Technique (mSMT) in Persons With TBI
- ClinicalTrials.gov ID
- NCT04056312
- Acronym / sponsor ID
- R-926-16
- Conditions
- Traumatic Brain Injury
- Keywords
- memory, learning, cognition, traumatic brain injury, treatment and therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 29 Jun 2016 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 14 Aug 2019 (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 current RCT is designed to:
- test the efficacy of the group based mSMT in persons with TBI on NPE, the current gold-standard for measuring memory functioning
- assess the effectiveness of the group mSMT on more global measures of everyday life, including an objective measure shown through our previous work to be sensitive to memory changes following the mSMT, as well as additional questionnaires to be completed by both the participant and a significant other
- evaluate the changes in brain functioning following treatment with the mSMT via fMRI and
- evaluate the long-term effects of the treatment protocol.
To accomplish these goals investigators will conduct a double-blind, placebo-controlled, RCT, applying the group mSMT to a sample of 60 participants with moderate to severe TBI (30 treatment; 30 control).
Detailed description
Outcome measures will assess objective memory abilities, everyday memory abilities and patterns of cerebral activation during learning. A long-term follow-up assessment will be conducted, designed to measure the impact of the mSMT 3 months following treatment completion. Alternate forms will be utilized wherever available.
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 |
|---|---|---|
| Group memory retraining | Experimental | Behavioral: Group Memory retraining exercisesExperimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group. |
| Placebo | Placebo comparator | Behavioral: Placebo controlled group memory exercise trainingExperimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- I am between the ages of 18-65.
- I have had a Traumatic Brain Injury at least one year ago.
- I can read and speak English fluently.
- I have difficulties with learning and memory skills.
Key exclusion criteria (5 listed)
- I am currently taking steroids and /or benzodiazepines as determined by study staff review of my medications.
- I have had a prior stroke or neurological injury/disease other than a traumatic brain injury.
- I have a history of significant psychiatric illness (for example, bipolar disorder or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
- I have unstable or uncontrolled seizures.
- I have a significant alcohol or drug abuse history.
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 |
|---|---|---|
| Group Memory retraining exercisesExperimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group. | Behavioural | Group memory retraining |
| Placebo controlled group memory exercise trainingPlacebo group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group. | Behavioural | Placebo |
Primary outcome
California Verbal Learning Test
Time frame: Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later
Change on scores on memory tests will be assessed using the California Verbal Learning Test
The Traumatic Brain Injury-Quality of Life Scale
Time frame: Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later
Self-reports of emotional functioning, memory functioning and quality of life on The Traumatic Brain Injury-Quality of Life Scale, which measures these constructs. DVs will be change on the Depression subscale (range: 0-40; lower score is better) and Cognition scale (range: 0-40; higher score is better).
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 22 Jul 2026.
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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.
Richard Green, PhD study chair
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Memory retraining exercises in people with Traumatic Brain Injury, run by Kessler Foundation 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 4 inclusion and 5 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 22 Jul 2026. 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. Some participants in this study may receive a placebo. 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?
California Verbal Learning Test (time frame: Change will be assessed. Scales will be administered at 3 time points;pretreatment immediately following 5 months later). The study lists 2 primary outcomes in all. 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 22 Jul 2026.