Traumatic Brain InjuryPACTNCT04560946

Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans with a History of TBI

A study testing Personalized Augmented Cognitive Training (PACT) and Enhanced Treatment As Usual in people with Traumatic Brain Injury, run by Veterans Medical Research Foundation at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Traumatic Brain Injury
What is being tested?: Personalized Augmented Cognitive Training (PACT) and Enhanced Treatment As Usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 107 participants
Where: 2 sitesUnited States
Study dates: 30 Sep 2019to 30 Sep 2023
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 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

All participants:
Male or female
All racial and ethnic groups
Ages 18 to 55
Veteran or service member
History of mild TBI (as defined by the DoD/VA criteria used in conjunction with the OSU TBIID method)
Score of ≥4 on the cognitive subscale of the Neurobehavioral Symptom Inventory reflecting 'very severe' symptoms in at least one area or at least 'mild' symptoms in all four areas surveyed
have a compatible device (computer, tablet, or smartphone) with internet connection (wifi or cellular plan).

Who cannot join

Mild TBI sustained < 3 months previously
History of moderate, severe, or penetrating TBI
History of other neurological condition unrelated to TBI
Current psychiatric disturbance that would preclude study participation (e.g. clinically significant mania or psychosis)
Current substance use disorder
Current, active suicidal or homicidal ideation

Show all 11Show fewer

Current use of benzodiazepines or medications with anticholinergic effects
Not stable on psychiatric medications for at least 6 weeks
Impaired decision making capacity
Unable to provide voluntary informed consent
Previously completed >4 sessions of cognitive rehabilitation

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Naval Medical Center San Diego
San Diego, California, 92134
VA San Diego Healthcare System
San Diego, California, 92161

Other trials in United States

About this study

Mild traumatic brain injury (TBI) is a common medical condition that occurs when a head injury causes someone to lose consciousness, feel dazed or confused, or be unable to remember events occurring immediately after the injury. While most individuals with mild TBI recover within weeks or months, some individuals with mild TBI report chronic symptoms such as difficulty with cognitive skills like attention, learning, or memory, along with other symptoms such as irritability or headache. Previous studies, including those conducted by our scientific team, have shown that cognitive rehabilitation can help patients with persistent symptoms after mild TBI return to full duty, work, school, and other important life activities. Specifically, cognitive rehabilitation can provide lasting improvements in thinking abilities, functional capacity, post-concussive symptoms, and quality of life after mild TBI. However, effective interventions are still out of reach for many service members and Veterans with TBI. For patients who have returned to duty, employment, or education, scheduling up to 60 hours of treatment (a typical treatment schedule in many settings) may not be feasible. Additionally, some patients may live in areas where it is burdensome to make numerous visits to a medical center. Personalized Augmented Cognitive Training (PACT) compresses treatment into six hours of once-weekly personalized, one-on-one training by selecting treatment modules based on patient needs and priorities-substantially reducing the total amount of time required to complete treatment. PACT can be offered either in-person (in clinic) or via home-based video telemedicine, depending upon patients' preferences. Additionally, PACT includes training and encouragement for service members and Veterans to make self-directed use of mobile apps that train cognitive skills and strategies.The primary goal of this study is to evaluate whether PACT is effective at improving cognition, symptoms, and functional outcomes among military service members and Veterans with a history of mild TBI. The study will also yield information about factors that can enhance or interfere with treatment, such as number of previous TBIs, presence of post-traumatic stress; and choice of in-person vs. video telemedicine delivery of care.

Conditions: Traumatic Brain Injury
Being tested: Personalized Augmented Cognitive Training (PACT), Enhanced Treatment As Usual
Keywords: traumatic brain injury, cognitive rehabilitation
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.

Personalized Augmented Cognitive Training (PACT)Behavioural
Personalized Augmented Cognitive Training (PACT) group. Intervention: Behavioral: The study neuropsychologist will use a portion of the TBI education session to describe available treatment modules and make recommendations for module selection based on results from baseline assessment. After discussion, five 60-minute CogSMART modules will be selected. PACT participants will receive guidance to complete 2 modules per week of the CogSMART app. PACT participants will also receive guidance to complete BrainHQ exercises of their choice for 30 minutes a day, 5 days per week, for a total training time of 15 hours.
Enhanced Treatment As UsualBehavioural
Enhanced Treatment As Usual (ETAU) group. Intervention: Behavioral: The ETAU condition was designed to replicate treatment as usual following neuropsychological assessment of post-TBI cognitive problems. Treatment as usual for mTBI patients at the VA hospital usually consists of: 1) A general evaluation by the polytrauma clinic, 2) Possible neuropsychological assessment evaluation by the TBI Cognitive Rehabilitation Clinic, and 3) If impairments are present, cognitive rehabilitation is offered. The current study's condition is considered "enhanced" treatment as usual because standard of care for chronic mTBI does not always involve neuropsychological assessment with feedback and psychoeducation or the provision of self-directed tools such as the CogSMART app or BrainHQ cognitive training software.

Study groups in NCT04560946
Study group	Role	What they receive
PACT	Experimental	Personalized Augmented Cognitive Training (PACT) Receives: Behavioral: Personalized Augmented Cognitive Training (PACT)
ETAU	Active comparator	Enhanced Treatment As Usual (ETAU) Receives: Behavioral: Enhanced Treatment As Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Neurobehavioral Symptom Inventory (NSI)
Measure of post concussive symptoms
Measured: 6, 12 weeks

Secondary outcomes (14)

Change in UCSD Performance-Based Skills Assessment-B (UPSA-B)
Measure of everyday communication and financial capacity
Measured: 6, 12 weeks
Change in WMS-IV Digit Span
Measure of verbal working memory
Measured: 6, 12 weeks
Change in California Verbal Learning Test-III (CVLT-III)
Measure of verbal and learning memory
Measured: 6, 12 weeks
Change in D-KEFS Verbal Fluency
Measure of executive function
Measured: 6, 12 weeks
Change in Oral Trails
Measure of visual psychomotor, and executive processes
Measured: 6, 12 weeks
Change in Test My Brain Continuous Performance Test
Measure of sustained attention
Measured: 6, 12 weeks
Change in Test My Brain Matrix Reasoning
Measure of visual reasoning
Measured: 6, 12 weeks
Change in Test My Brain Digit Symbol Matching
Measure of visual scanning and information processing speed
Measured: 6, 12 weeks
Change in Test My Brain Choice Reaction Time
Measure of reaction time
Measured: 6, 12 weeks
Change in the Pittsburgh Sleep Quality Index (PSQI)
Measure of sleep quality and disturbances over the past month
Measured: 6, 12 weeks
Change in Cognitive Problems and Strategies Assessment
Measure of frequency of use of common strategies to enhance cognitive performance, as well as perceived cognitive problems
Measured: 6, 12 weeks
Change in Patient Global Impression of Change (PGIC)
Measure of activity limitations, symptoms, and overall quality of life
Measured: 6, 12 weeks
Change in Traumatic Brain Injury Quality of Life (TBI-QoL)
Measure of patient reported outcomes and NINDS CDEs for TBI
Measured: 6, 12 weeks
Change in WHO Disability Assessment Schedule (WHODAS) 2.0 (plus supplementary questions for duty status, work/school)
Measure of function in the following areas: life activities (work, school, domestic responsibilities), cognition, mobility, self-care, social, and community participation. To supplement the WHODAS 2.0, we will also ask supplemental questions regarding current duty status (for military service members), and number of hours of work/school per week
Measured: 6, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 201930 Sep 2023

First posted23 Sep 2020
Study start30 Sep 2019
Primary completion30 Sep 2023
Study completion30 Sep 2023

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.
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
Model description: Two group randomized controlled trial.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04560946
Sponsor's protocol ID: W81XWH1910656
Acronym: PACT
Status last verified: Apr 2023
First submitted: 16 Sep 2020
Last updated: 21 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No individual participant data will be shared with other researchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans with a History of TBI
ClinicalTrials.gov ID: NCT04560946
Acronym / sponsor ID: PACT / W81XWH1910656
Conditions: Traumatic Brain Injury
Keywords: traumatic brain injury, cognitive rehabilitation
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: Veterans Medical Research FoundationUniversity, hospital or other
Collaborators: United States Naval Medical Center, San Diego
Study start: 30 Sep 2019 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 30 Sep 2023 (actual)
First posted: 23 Sep 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Two group randomized controlled trial.

Arm	Type	Receives
PACT	Experimental	Behavioral: Personalized Augmented Cognitive Training (PACT)Personalized Augmented Cognitive Training (PACT)
ETAU	Active comparator	Behavioral: Enhanced Treatment As UsualEnhanced Treatment As Usual (ETAU)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Male or female
All racial and ethnic groups
Ages 18 to 55
Veteran or service member
History of mild TBI (as defined by the DoD/VA criteria used in conjunction with the OSU TBIID method)

Key exclusion criteria (11 listed)

Mild TBI sustained < 3 months previously
History of moderate, severe, or penetrating TBI
History of other neurological condition unrelated to TBI
Current psychiatric disturbance that would preclude study participation (e.g. clinically significant mania or psychosis)
Current substance use disorder

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
Personalized Augmented Cognitive Training (PACT)Personalized Augmented Cognitive Training (PACT) group. Intervention: Behavioral: The study neuropsychologist will use a portion of the TBI education session to describe available treatment modules and make recommendations for module selection based on results from baseline assessment. After discussion, five 60-minute CogSMART modules will be selected. PACT participants will receive guidance to complete 2 modules per week of the CogSMART app. PACT participants will also receive guidance to complete BrainHQ exercises of their choice for 30 minutes a day, 5 days per week, for a total training time of 15 hours.	Behavioural	PACT
Enhanced Treatment As UsualEnhanced Treatment As Usual (ETAU) group. Intervention: Behavioral: The ETAU condition was designed to replicate treatment as usual following neuropsychological assessment of post-TBI cognitive problems. Treatment as usual for mTBI patients at the VA hospital usually consists of: 1) A general evaluation by the polytrauma clinic, 2) Possible neuropsychological assessment evaluation by the TBI Cognitive Rehabilitation Clinic, and 3) If impairments are present, cognitive rehabilitation is offered. The current study's condition is considered "enhanced" treatment as usual because standard of care for chronic mTBI does not always involve neuropsychological assessment with feedback and psychoeducation or the provision of self-directed tools such as the CogSMART app or BrainHQ cognitive training software.	Behavioural	ETAU

Primary outcome

Change in the Neurobehavioral Symptom Inventory (NSI)
Time frame: 6, 12 weeks
Measure of post concussive symptoms

14 secondary outcomes

Change in UCSD Performance-Based Skills Assessment-B (UPSA-B)
Time frame: 6, 12 weeks
Change in WMS-IV Digit Span
Time frame: 6, 12 weeks
Change in California Verbal Learning Test-III (CVLT-III)
Time frame: 6, 12 weeks
Change in D-KEFS Verbal Fluency
Time frame: 6, 12 weeks
Change in Oral Trails
Time frame: 6, 12 weeks
Change in Test My Brain Continuous Performance Test
Time frame: 6, 12 weeks
Change in Test My Brain Matrix Reasoning
Time frame: 6, 12 weeks
Change in Test My Brain Digit Symbol Matching
Time frame: 6, 12 weeks
Change in Test My Brain Choice Reaction Time
Time frame: 6, 12 weeks
Change in the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 6, 12 weeks
Change in Cognitive Problems and Strategies Assessment
Time frame: 6, 12 weeks
Change in Patient Global Impression of Change (PGIC)
Time frame: 6, 12 weeks
Change in Traumatic Brain Injury Quality of Life (TBI-QoL)
Time frame: 6, 12 weeks
Change in WHO Disability Assessment Schedule (WHODAS) 2.0 (plus supplementary questions for duty status, work/school)
Time frame: 6, 12 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 21 Nov 2024.
Individual participant dataSharing planned: No. No individual participant data will be shared with other researchers.

Related trials for Traumatic Brain Injury

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Recruiting
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Valproic AcId for Traumatic BRAin INjury Trial
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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.

Elizabeth W Twamley, PhD principal investigator

Veterans Medical Research Foundation

Mark L Ettenhofer, PhD principal investigator

Veterans Medical Research Foundation

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 11 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 21 Nov 2024. 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. 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?

Change in the Neurobehavioral Symptom Inventory (NSI) (time frame: 6, 12 weeks). 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 NCT04560946.

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 21 Nov 2024.