Traumatic Brain InjuryNCT02020564
Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment
A study testing Speed of Processing Training in people with Traumatic Brain Injury and Mild Cognitive Impairment, 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 technique designed to improve processing speed (i.e. the amount of time it takes to process information) in a Traumatic Brain Injury (TBI) population. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Traumatic Brain Injury, Mild Cognitive Impairment
- What is being tested?
- Speed of Processing Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2012to 30 Dec 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of Traumatic Brain Injury or Mild cognitive impairment
- Fluent in English
- processing speed impairment
Who cannot join
- prior stroke or neurological disease
- currently taking steroids and/or benzodiazepines
- history of significant pyschiatric illness (for example, bipolar disorder, schizophrenia, or pyschosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
- significant alcohol or drug abuse history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment: A Randomized Clinical Trial
The purpose of this research study is to investigate the effectiveness of a technique designed to improve processing speed (i.e. the amount of time it takes to process information) in a Traumatic Brain Injury (TBI) population. The study is designed to study how well this technique can help people with TBI increase their processing speed and their ability to function better in everyday life.
Read the detailed description
The current proposal is designed to apply this treatment protocol to a large sample of individuals with moderate to severe TBI with documented impairment in PS. The goals of the trial are to (a) test the efficacy of this treatment protocol within a TBI population, (b) evaluate the impact of the treatment on everyday functioning, (c) evaluate the longer-term efficacy of the treatment, and (d) examine the utility of booster sessions in facilitating longer-term treatment effects. Individuals with moderate to severe TBI, with documented impairment in PS, will be randomly assigned to a treatment group or a control group. Both groups will undergo baseline, immediate post-treatment and long-term follow-up assessment consisting of: (1) a standardized neuropsychological battery and (2) an assessment of global functioning examining the impact of the treatment on daily activities. This design will allow us to assess the efficacy of SPT in persons with TBI and evaluate its impact on everyday life.
- Conditions
- Traumatic Brain Injury, Mild Cognitive Impairment
- Being tested
- Speed of Processing Training, Placebo Control
- Keywords
- Processing Speed, Cognition, Intervention, Traumatic Brain Injury, Mild Cognitive Impairment
- Medical subject headings
- Brain Injuries, Traumatic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Speed of Processing TrainingBehavioural
Placebo ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Computerized exercised will be administered on a laptop computer twice a week for 5 weeks (10 training sessions). Receives: Behavioral: Speed of Processing Training |
| Placebo control group | Placebo comparator | Computerized exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions). Receives: Behavioral: Placebo Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symbol-Digit Modalities Test
Change in scores on standardized neuropsychological tests of Processing Speed using Symbol-Digit Modalities Test
Measured: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Secondary outcomes (3)
TBI Quality of Life, Depression scale
Change in scores on self-report of emotional functioning, measured via questionnaire. The TBI QOL Depression scale measures depression. The range is 1-40. A higher score indicates greater depression.
Measured: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Perceived Deficits Questionnaire
Change in scores on self-report of perceived cognitive deficits in daily life, measured via questionnaire. A higher score indicates greater perceived deficits in daily life. Range of scores on the scale is 0-80.
Measured: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
TBI Quality of Life, Total Score
Change in scores on self-report of quality of life, measured via questionnaire. DV is the TBI-QOL total score. The range is 1-40. A higher score indicates better quality of life.
Measured: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study start12 Dec 2012
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Chiaravalloti, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020564
- Sponsor's protocol ID
- R-755-12
- Status last verified
- Jan 2023
- First submitted
- 19 Dec 2013
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Goverover Y, Costa SL, DeLuca J, Chiaravalloti N. Does speed of processing training improve everyday life functional activity in traumatic brain injury: A pilot randomized controlled trial. Neuropsychol Rehabil. 2026 May;36(4):714-729. doi: 10.1080/09602011.2025.2526663. Epub 2025 Jul 4.
PubMed 40615123
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
- Speed of Processing Training to Improve Cognition in Traumatic Brain Injury and Mild Cognitive Impairment: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02020564
- Acronym / sponsor ID
- R-755-12
- Conditions
- Traumatic Brain Injury, Mild Cognitive Impairment
- Keywords
- Processing Speed, Cognition, Intervention, Traumatic Brain Injury, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 12 Dec 2012 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 25 Dec 2013 (estimated)
- 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 technique designed to improve processing speed (i.e. the amount of time it takes to process information) in a Traumatic Brain Injury (TBI) population. The study is designed to study how well this technique can help people with TBI increase their processing speed and their ability to function better in everyday life.
Detailed description
The current proposal is designed to apply this treatment protocol to a large sample of individuals with moderate to severe TBI with documented impairment in PS. The goals of the trial are to (a) test the efficacy of this treatment protocol within a TBI population, (b) evaluate the impact of the treatment on everyday functioning, (c) evaluate the longer-term efficacy of the treatment, and (d) examine the utility of booster sessions in facilitating longer-term treatment effects. Individuals with moderate to severe TBI, with documented impairment in PS, will be randomly assigned to a treatment group or a control group. Both groups will undergo baseline, immediate post-treatment and long-term follow-up assessment consisting of: (1) a standardized neuropsychological battery and (2) an assessment of global functioning examining the impact of the treatment on daily activities. This design will allow us to assess the efficacy of SPT in persons with TBI and evaluate its impact on everyday life.
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 |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Speed of Processing TrainingComputerized exercised will be administered on a laptop computer twice a week for 5 weeks (10 training sessions). |
| Placebo control group | Placebo comparator | Behavioral: Placebo ControlComputerized exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions). |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- diagnosis of Traumatic Brain Injury or Mild cognitive impairment
- Fluent in English
- processing speed impairment
Key exclusion criteria (4 listed)
- prior stroke or neurological disease
- currently taking steroids and/or benzodiazepines
- history of significant pyschiatric illness (for example, bipolar disorder, schizophrenia, or pyschosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
- 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 |
|---|---|---|
| Speed of Processing Training | Behavioural | Treatment Group |
| Placebo Control | Behavioural | Placebo control group |
Primary outcome
Symbol-Digit Modalities Test
Time frame: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Change in scores on standardized neuropsychological tests of Processing Speed using Symbol-Digit Modalities Test
3 secondary outcomes
TBI Quality of Life, Depression scale
Time frame: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
Perceived Deficits Questionnaire
Time frame: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
TBI Quality of Life, Total Score
Time frame: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention
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.
- Derived from this study: PubMed 40615123Goverover Y, Costa SL, DeLuca J, Chiaravalloti N. Does speed of processing training improve everyday life functional activity in traumatic brain injury: A pilot randomized controlled trial. Neuropsychol Rehabil. 2026 May;36(4):714-729. doi: 10.1080/09602011.2025.2526663. Epub 2025 Jul 4.
Related trials for Traumatic Brain Injury
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
Not yet recruitingObservational study
A Prospective Study of Cognitive Changes in Retired and Late-Career Professional Soccer Players
Cognitive Impairment, Chronic Traumatic Encephalopathy (CTE)
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Speed of Processing Training in people with Traumatic Brain Injury and Mild Cognitive Impairment, 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 3 inclusion and 4 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?
Symbol-Digit Modalities Test (time frame: Baseline (week 1), immediately post-intervention (week 7) and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02020564, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 3 Nov 2026.