Foundations in Developing Precision Cognitive Restoration

NCT05117502 | Withdrawn DMC FDA Device

• 1 other identifier: N3751-P
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Moderate Cognitive Impairment; Traumatic Brain Injury; Stroke

Keywords

Pilot projects; Cognition Disorders; Stroke; Brain Injury; Brain Injury, Traumatic; Activities of Daily Living; Working Memory

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span subtest

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

Study Arms (2)

intermittent Theta Burst Stimulation

EXPERIMENTAL

Participants 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).

Device: intermittent Theta Burst Stimulation

Placebo intermittent Theta Burst Stimulation

PLACEBO COMPARATOR

Placebo 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).

Device: Placebo intermittent Theta Burst Stimulation

Interventions

intermittent Theta Burst Stimulation DEVICE

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.

Also known as: iTBS, TMS, rTMS

intermittent Theta Burst Stimulation

Placebo intermittent Theta Burst Stimulation DEVICE

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.

Also known as: Placebo or Sham TMS, iTMS, rTMS

Placebo intermittent Theta Burst Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of TBI or Ischemic Stroke
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Stroke; Cognition Disorders; Brain Injuries

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Theresa L Pape, DrPH MA BS

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After the participant has been consented and meets all study enrollment criteria, the participant will be randomized to a sham or real iTBS treatment. The participant and treating researcher will be blinded. A unique code for the iTBS (Magstim) will be provided by an unblinded research team member, this will provide the sham or real treatment to the participant.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 11, 2021
• Study Start: February 24, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)