Foundations in Developing Precision Cognitive Restoration
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05117502|
Recruitment Status : Not yet recruiting
First Posted : November 11, 2021
Last Update Posted : November 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Moderate Cognitive Impairment Traumatic Brain Injury Stroke||Device: intermittent Theta Burst Stimulation Device: Placebo intermittent Theta Burst Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||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.|
|Official Title:||Foundational Elements of an Alternate Scientific Approach to Developing Veteran-centric Precision Cognitive Restoration Interventions|
|Estimated Study Start Date :||April 1, 2022|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: intermittent Theta Burst Stimulation
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
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.
Other Name: iTBS, TMS, rTMS
Placebo Comparator: Placebo intermittent Theta Burst Stimulation
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
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.
Other Name: Placebo or Sham TMS, iTMS, rTMS
- 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 ]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.
- Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span subtest [ Time Frame: 5 timepoints: week 1 before and after intervention, week 3 before and after intervention, week 5 as follow-up ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05117502
|Contact: Theresa L Pape, DrPH MA BS||(708) 202-8387 ext email@example.com|
|Contact: Cheryl C Odle, MBA||(708) 202-8387 ext firstname.lastname@example.org|
|United States, Illinois|
|Edward Hines Jr. VA Hospital, Hines, IL|
|Hines, Illinois, United States, 60141-5000|
|Contact: William Wolf, PhD 708-202-5689 William.Wolf@va.gov|
|Contact: Amanda Smithy (708) 202-8387 ext 25691 Amanda.Smithy@va.gov|
|Principal Investigator: Theresa L Pape, DrPH MA BS|
|Principal Investigator:||Theresa L Pape, DrPH MA BS||Edward Hines Jr. VA Hospital, Hines, IL|