Spinal Cord InjuriesNCT03985540
Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI)
A study testing Behavorial; memory exercise and Behavioral: speed exercises in people with Spinal Cord Injuries, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the effectiveness of a memory retraining program and a processing speed program in a spinal cord injured (SCI) population. The study is designed to research how well different types of techniques can help people with SCI improve in areas where they might have… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Behavorial; memory exercise and Behavioral: speed exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2016to 14 Nov 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- I am between the ages of 18 and 75 years old.
- I have a spinal cord injury with the level of injury between C1-T12.
- I am non-ambulatory (I use a wheelchair as my primary means of getting around).
- I have an AIS grade of A, B or C as determined by study staff examination.
- My injury occurred at least 1 year ago.
- My primary language is English.
Who cannot join
- I have a current illness or infection. My enrollment in this study can be delayed until my current illness or infection is successfully treated.
- I have any neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.).
- I have a diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder.
- I have a history of Hypertension or Diabetes Mellitus (due to its impact on brain function).
- My vision is impaired- more than 20/60 in worst eye (with prescription eyewear).
- I have been taking steroids, benzodiazepines, or certain neuroleptics within past month, the study doctor will review my medications with me.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI): A Randomized Clinical Trial
The purpose of this research study is to investigate the effectiveness of a memory retraining program and a processing speed program in a spinal cord injured (SCI) population. The study is designed to research how well different types of techniques can help people with SCI improve in areas where they might have difficulties such as memory or processing speed, (time it takes to process information provided).
Read the detailed description
The objectives of the currently proposed randomized clinical trial are to (1) apply a treatment protocol for Processing Speed and Learning and memory impairments, well-validated in other neurological populations, to individuals with SCI with objectively observable deficits in these areas and document efficacy on standard neuropsychological testing; (2) assess the effectiveness of the interventions in persons with SCI utilizing global measures of everyday life; (3) evaluate the long-term benefit of treatment. Prior to enrollment in the study protocol, all potential subjects will undergo a 2-part screening: (1) an initial screening examination via telephone during which basic information will be gathered and (2) a detailed, in-person screening that will be completed on if the subject passes the initial screen. Individuals must meet full screening criteria to be eligible for participation.
- Conditions
- Spinal Cord Injuries
- Being tested
- Behavorial; memory exercise, Placebo; memory exercise, Behavioral: speed exercises, Placebo speed training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavorial; memory exerciseBehavioural
Memory training twice a week for 5 weeks.
Placebo; memory exerciseBehavioural
Placebo Memory training twice a week for 5 weeks
Behavioral: speed exercisesBehavioural
Speed training twice a week for 5 weeks.
Placebo speed trainingBehavioural
Placebo Speed training twice a week for 5 weeks.
| Study group | Role | What they receive |
|---|---|---|
| memory experimental group | Experimental | Experimental group will receive memory retraining exercises administered on a lab top computer twice a week for 5 weeks. Receives: Behavioral: Behavorial; memory exercise |
| Placebo comparator memory | Placebo comparator | Placebo controlled group will receive placebo memory retraining exercises administered on a lab top computer twice a week for 5 weeks. Receives: Behavioral: Placebo; memory exercise |
| Processing speed | Experimental | Processing speed group will receive processing speed training exercises administered on a lab top computer twice a week for 5 weeks. Receives: Behavioral: Behavioral: speed exercises |
| Processing speed placebo | Placebo comparator | Placebo controlled group will receive placebo processing speed training exercises administered on a lab top computer twice a week for 5 weeks. Receives: Behavioral: Placebo speed training |
What is being measured
The primary outcome is the main question the study is designed to answer.
California Verbal Learning Test
California Verbal Learning TestPerformance on a memory test using the
Measured: Assessments will look at change over 6 weeks of treatment and 3 months after completion
Secondary outcomes (1)
SCI Quality of Life Scale
Reports on emotional functioning, memory functioning and quality of life using the SCI Quality of Life Scale, which measures all of these constructs. DVs will be the depression subscale (range: 0-40; lower score is better) and cognitive subscale (range:0-40; higher score is better).
Measured: Assessments will look at change over 6 weeks of treatment and 3 months after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start16 Nov 2016
- Primary completion30 Oct 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, Nancy Chiaravalloti, Kessler Foundation
- Investigators
- Richard Green, PhD, Study chair, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985540
- Sponsor's protocol ID
- R-947-16
- Status last verified
- Jan 2023
- First submitted
- 15 Aug 2017
- Last updated
- 18 Jan 2023
- 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 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Cognitive Deficits in Traumatic Spinal Cord Injury (SCI): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03985540
- Acronym / sponsor ID
- R-947-16
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 13 Jun 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 purpose of this research study is to investigate the effectiveness of a memory retraining program and a processing speed program in a spinal cord injured (SCI) population. The study is designed to research how well different types of techniques can help people with SCI improve in areas where they might have difficulties such as memory or processing speed, (time it takes to process information provided).
Detailed description
The objectives of the currently proposed randomized clinical trial are to (1) apply a treatment protocol for Processing Speed and Learning and memory impairments, well-validated in other neurological populations, to individuals with SCI with objectively observable deficits in these areas and document efficacy on standard neuropsychological testing; (2) assess the effectiveness of the interventions in persons with SCI utilizing global measures of everyday life; (3) evaluate the long-term benefit of treatment. Prior to enrollment in the study protocol, all potential subjects will undergo a 2-part screening: (1) an initial screening examination via telephone during which basic information will be gathered and (2) a detailed, in-person screening that will be completed on if the subject passes the initial screen. Individuals must meet full screening criteria to be eligible for participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| memory experimental group | Experimental | Behavioral: Behavorial; memory exerciseExperimental group will receive memory retraining exercises administered on a lab top computer twice a week for 5 weeks. |
| Placebo comparator memory | Placebo comparator | Behavioral: Placebo; memory exercisePlacebo controlled group will receive placebo memory retraining exercises administered on a lab top computer twice a week for 5 weeks. |
| Processing speed | Experimental | Behavioral: Behavioral: speed exercisesProcessing speed group will receive processing speed training exercises administered on a lab top computer twice a week for 5 weeks. |
| Processing speed placebo | Placebo comparator | Behavioral: Placebo speed trainingPlacebo controlled group will receive placebo processing speed training exercises administered on a lab top computer twice a week for 5 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- I am between the ages of 18 and 75 years old.
- I have a spinal cord injury with the level of injury between C1-T12.
- I am non-ambulatory (I use a wheelchair as my primary means of getting around).
- I have an AIS grade of A, B or C as determined by study staff examination.
- My injury occurred at least 1 year ago.
Key exclusion criteria (6 listed)
- I have a current illness or infection. My enrollment in this study can be delayed until my current illness or infection is successfully treated.
- I have any neurological condition other than SCI (Alzheimer's disease, dementia, stroke, multiple sclerosis, Parkinson's disease, etc.).
- I have a diagnosis of a psychiatric disorder such as post-traumatic stress disorder, schizophrenia or bipolar disorder.
- I have a history of Hypertension or Diabetes Mellitus (due to its impact on brain function).
- My vision is impaired- more than 20/60 in worst eye (with prescription eyewear).
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 |
|---|---|---|
| Behavorial; memory exerciseMemory training twice a week for 5 weeks. | Behavioural | memory experimental group |
| Placebo; memory exercisePlacebo Memory training twice a week for 5 weeks | Behavioural | Placebo comparator memory |
| Behavioral: speed exercisesSpeed training twice a week for 5 weeks. | Behavioural | Processing speed |
| Placebo speed trainingPlacebo Speed training twice a week for 5 weeks. | Behavioural | Processing speed placebo |
Primary outcome
California Verbal Learning Test
Time frame: Assessments will look at change over 6 weeks of treatment and 3 months after completion
California Verbal Learning TestPerformance on a memory test using the
1 secondary outcome
SCI Quality of Life Scale
Time frame: Assessments will look at change over 6 weeks of treatment and 3 months after completion
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 18 Jan 2023.
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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 Behavorial; memory exercise and Behavioral: speed exercises in people with Spinal Cord Injuries, 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 6 inclusion and 6 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 18 Jan 2023. 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: Assessments will look at change over 6 weeks of treatment and 3 months after completion). 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 18 Jan 2023.