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Moderate Cognitive ImpairmentNCT05117502

Foundations in Developing Precision Cognitive Restoration

A study testing intermittent Theta Burst Stimulation in people with Moderate Cognitive Impairment and Traumatic Brain Injury, run by VA Office of Research and Development at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This pilot study tests the merits of a unique research approach, transdiagnostic sampling. For Veterans with similar levels of cognitive impairments cause by different types of brain injuries (stroke or traumatic brain injury), this study examines effects of two cognitive restorative treatments. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
intermittent Theta Burst Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
24 Feb 2022to 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of TBI or Ischemic Stroke
  • 2-10 years post neurologic event having completed rehabilitation
  • Age 18 - 80 years old
  • Medically stable
  • Fluent in English
  • Moderately impaired cognitive function as defined by AMPS Processing sub-scale measures falling below 1.0 logits
  • Moderately impaired cognitive capacity as defined by having two or more scores falling 1 standard deviation below age normed expectations on: the RBANS index scores, DKEFS Color-Word Trials 3 and 4 scale scores, and/or WAIS-IV Digit Span scaled score

Who cannot join

  • Have BOTH TBI and Ischemic Stroke
  • Intracranial lesions or hemorrhagic stroke
  • Other primary neurologic diagnosis
  • Any dementia diagnosis
  • Reside in an extended care facility
  • Less than 2 years post TBI or ischemic stroke
Show all 21Show fewer
  • Anti-epileptic medications for seizure activity
  • Seizure within the past 3 months or active seizure
  • Contraindications to MRI/iTBS
  • Medication changes within 3 months of starting participation
  • Currently receiving therapy services
  • Pregnancy
  • FIM scores for problem solving <3 or >4 OR memory <4 or >5, or changes in FIM scores during screening process
  • Neurostimulants that cannot be safely withdrawn
  • Bilateral ischemic stroke
  • Mild or severe impairments in cognitive capacity or cognitive function
  • CHF, implanted pacemakers or defibrillators, or cochlear implants
  • Questionable test validity as indicated by DOT (E-score 17) or BRIEF (Negativity 6; Infrequency 3; Inconsistency 8)
  • RBANS Total Scale < 70
  • History of/or symptoms of psychotic spectrum disorders (i.e., bipolar, schizophrenia)
  • Persons with alcohol use disorder (AUD) and/or substance use disorder (SUD) diagnoses confirmed by clinical and/or scientific experts

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinois, 60141-3030

Other trials in United States

About this study

Official title: Foundational Elements of an Alternate Scientific Approach to Developing Veteran-centric Precision Cognitive Restoration Interventions

This pilot study tests the merits of a unique research approach, transdiagnostic sampling. For Veterans with similar levels of cognitive impairments cause by different types of brain injuries (stroke or traumatic brain injury), this study examines effects of two cognitive restorative treatments. Instead of using the traditional approach to examine treatment effects strictly by cause of brain injury, the transdiagnostic sampling approach recognizes that cause of injury does not drive treatment responsiveness of recovery.

Read the detailed description

The purpose of this study is to identify the supports and barriers to scalability of Veteran-tailored iTBS and APT across neurologic conditions, with the longer-term goal of providing an empirical basis for the tailoring of a broader range of cognitive rehabilitation strategies to optimize each Veteran's cognitive function in daily life. After Veterans receive standard cognitive rehabilitation, cognitive impairments often persist and if they do make gains there is limited carry-over to daily function. The tenets of precision neurorehabilitation suggest that tailored interventions will optimize gains and carry-over, but precision-tailoring of cognitive rehabilitation will only be possible if researchers develop and test scalable approaches for identifying, organizing, and analyzing the multitude of Veteran-specific variables driving and influencing treatment responsiveness. This project addresses long-standing scientific barriers to understanding treatment responsiveness, particularly study sample heterogeneity and individual variability. The investigators address study sample heterogeneity by linking Veterans, across TBI and ischemic stroke, according to levels of cognitive impairment. The investigators create a cohort of Veterans with a homogeneous level of cognitive impairment, thereby enabling explication of person-centric factors influencing treatment responsiveness and carry-over to daily function. Advancing understanding of the basic study design elements will be achieved by leveraging the knowledge of intermittent Theta Burst Stimulation (iTBS) and iTBS paired with Attention Processing Training exercises (iTBS + APT). iTBS is advantageous as it robustly improves working memory with just one treatment session. These interventions, together, are advantageous as they can each be tailored to a Veteran's unique cognitive challenges and to target the neural site, unique to each Veteran's neuropathology. These two interventions also directly address cognitive deficits, while simultaneously inducing neuroplasticity in neural regions hampered or impaired by neural injury. The investigators will study Veterans with moderately impaired cognition who, after standard cognitive rehabilitation, continue to struggle with daily life requiring assistance with complex instrumental activities of daily living (IADL). Veterans will participate in a series of two within-subject treatment studies, conducted on two separate days, 2-weeks apart. Veterans will be randomly assigned to first receive a single session of Active iTBS or Placebo iTBS and then they will receive APT paired with their assigned iTBS (Active iTBS + APT vs Placebo iTBS + APT). The investigators will test if diagnosis moderates the effects of these interventions on both immediate and persisting change in cognition. For immediate effects, the investigators use a novel testing battery and for persisting gains the investigators use established and feasible neuropsychological tests as well as an established test of cognitive function during IADL. Results will be used to obtain pilot data and examine feasibility in terms of study attrition relative to Veteran fatigue, mood, and Veteran reports of suitability of key aspects of the study design. These findings will be used to develop a future merit within-subject cross-over study examining the over-arching hypothesis that tailored iTBS and APT applied to a transdiagnostic sample and subsequently matched to a Veteran, according to a biotype algorithm, will result in better functional performance of Veteran-valued IADL.

Being tested
intermittent Theta Burst Stimulation, Placebo intermittent Theta Burst Stimulation
Keywords
Pilot projects, Cognition Disorders, Stroke, Brain Injury, Brain Injury, Traumatic, Activities of Daily Living, Working Memory
Medical subject headings
Brain Injuries, Traumatic, Stroke, Cognition Disorders, Brain Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • intermittent Theta Burst StimulationDevice

    Also called iTBS, TMS, rTMS

    intermittent Theta Burst Stimulation (iTBS) is a type of repetitive transcranial magnetic stimulation (rTMS), which uses short magnetic field pulses applied to the scalp to induce currents in the underlying brain. iTBS will be delivered by the MagVenture MagPROX100 with MagOption Stimulator and MagPro Cool Coil B65 A/P. The MagPro Cool Coil B65 A/P can be switched from active to placebo.

  • Placebo intermittent Theta Burst StimulationDevice

    Also called Placebo or Sham TMS, iTMS, rTMS

    The placebo coil magnetic stimulation, but does not actually emit a pulse. The placebo coil looks, sounds and feels like an active iTBS coil. The placebo coil, visually identical to the active coil, provides a slight sensory sensation and discharge noise (i.e. clicking) nearly identical to that of the active coil.

Study groups in NCT05117502
Study groupRoleWhat they receive
intermittent Theta Burst StimulationExperimentalParticipants will receive 2 treatments of intermittent Theta Burst Stimulation, each two weeks apart. First session will be iTBS alone, the second session will be combined iTBS with APT (Attention processing training).
Receives: Device: intermittent Theta Burst Stimulation
Placebo intermittent Theta Burst StimulationPlacebo comparatorPlacebo iTBS participants will not receive any stimulation as the coil will be switched to placebo (P) setting. To maintain double-blind in A and P settings, Veterans and researchers wear headphones connected to a sham noise generator. Participants will receive 2 treatments of placebo intermittent Theta Burst Stimulation, each two weeks apart. First session will be iTBS alone, the second session will be combined placebo iTBS with APT (Attention processing training).
Receives: Device: Placebo intermittent Theta Burst Stimulation

What is being measured

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

  1. Streamlined Assessment of Motor and Process Skills (s-APMS) Change 5 timepoints: before and after 1st and 2nd session, then follow up

    Observational assessment by a trained researcher that measures the performance quality of tasks related to activities of daily living in a natural environment. Examples of activities could include light house work, laundry or meal preparation. The sAMPS assesses the quality of the participant's Activity of Daily Living performance by rating effort, efficiency, safety and independence of motor and processing skill items. The performance of these activities are item-level scores ranging from 1=no problem to 6=inordinate, cannot test. This is an observational test and the research clinician interprets AMPS reports to define and interpret reasons for the person's ineffective ADL performance.

    Measured: 5 timepoints: week 1 before and after intervention, week 3 before and after intervention, week 5 as follow-up

Secondary outcomes (1)
  1. Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span subtest

    Researcher administered verbal assessment use to measure auditory attention as well as working memory. The researcher verbally presents a sequence of numbers to the participant. The participant is to repeat the sequence back to the researcher. The test is administered in three subtest: Digit span forward, Digit Span Backward, and Digit Span Sequencing. Each subtest is scored with correct minus incorrect responses. The final scoring is completed researcher by raw scores and age.

    Measured: 5 timepoints: week 1 before and after intervention, week 3 before and after intervention, week 5 as follow-up

Timeline

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

  1. First posted11 Nov 2021
  2. Study start24 Feb 2022
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Why it stopped: PI Retirement and no one completed the consent process

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
All iTBS (intermittent Theta Burst Stimulation) sessions will be double-blinded, but the Attention procession sessions will not. This is a within-subject placebo-controlled partially-blinded treatment study.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05117502
Sponsor's protocol ID
N3751-P
Status last verified
Aug 2024
First submitted
12 Oct 2021
Last updated
29 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing intermittent Theta Burst Stimulation in people with Moderate Cognitive Impairment and Traumatic Brain Injury, run by VA Office of Research and Development 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 7 inclusion and 21 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: withdrawn, as of the sponsor's last update on 29 Aug 2024. 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 was withdrawn before enrolling participants, so there are no results.

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?

Streamlined Assessment of Motor and Process Skills (s-APMS) Change 5 timepoints: before and after 1st and 2nd session, then follow up (time frame: 5 timepoints: week 1 before and after intervention, week 3 before and after intervention, week 5 as follow-up). 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 29 Aug 2024.

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