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Behavioural Intervention
Theta Burst Stimulation for Cognitive Impairment
N/A
Waitlist Available
Led By Theresa L Pape, DrPH MA BS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 timepoints: week 1 before and after intervention, week 3 before and after intervention, week 5 as follow-up
Awards & highlights
Study Summary
This trial is testing if a new method, transdiagnostic sampling, is effective in treating Veterans with cognitive impairments caused by different types of brain injuries.
Who is the study for?
This trial is for Veterans aged 18-80 who are 2-10 years post a single neurologic event (TBI or ischemic stroke) and have moderate cognitive impairments. They must be medically stable, fluent in English, and not currently receiving therapy services. Excluded are those with mild/severe cognitive issues, recent medication changes, multiple brain injuries, certain medical devices/conditions, psychotic disorders history, substance abuse problems or seizures recently.Check my eligibility
What is being tested?
The study tests intermittent Theta Burst Stimulation (iTBS), a non-invasive brain stimulation technique against a placebo version to improve cognition in individuals with different types of brain injuries. It uses transdiagnostic sampling to see if treatment effects vary by the cause of injury or by the level of cognitive impairment.See study design
What are the potential side effects?
While iTBS is generally considered safe, potential side effects may include discomfort at the stimulation site on the scalp, headache during or after treatment sessions, lightheadedness and rarely seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 timepoints: week 1 before and after intervention, week 3 before and after intervention, week 5 as follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 timepoints: week 1 before and after intervention, week 3 before and after intervention, week 5 as follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Streamlined Assessment of Motor and Process Skills (s-APMS) Change 5 timepoints: before and after 1st and 2nd session, then follow up
Secondary outcome measures
Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span subtest
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: intermittent Theta Burst StimulationExperimental Treatment1 Intervention
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).
Group II: Placebo intermittent Theta Burst StimulationPlacebo Group1 Intervention
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).
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,598 Total Patients Enrolled
Theresa L Pape, DrPH MA BSPrincipal InvestigatorEdward Hines Jr. VA Hospital, Hines, IL
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a traumatic brain injury or stroke less than 2 years ago.Taking medication for seizures.You had a neurologic event (like a stroke or brain injury) 2-10 years ago and finished rehab.You are between 18 and 80 years old.You have difficulty thinking or remembering things.Your RBANS Total Scale score is less than 70.You have been diagnosed with traumatic brain injury or ischemic stroke.You have had a stroke on both sides of your brain.You have congestive heart failure or have certain medical devices implanted in your body.You have a history of or currently have symptoms of bipolar disorder or schizophrenia.You have been diagnosed with alcohol or drug addiction by a healthcare professional.You live in a nursing home or long-term care facility.You have trouble thinking or remembering things, as measured by specific tests.You have trouble with memory and thinking, as shown by certain test scores.You are taking medications that cannot be stopped safely.You have both traumatic brain injury and a type of stroke called ischemic stroke.You have a tumor or bleeding in your brain.You have low or high scores on problem solving or memory tests, or your scores change during the screening process.Your test results show that the test may not be accurate.You have a different main neurological condition.You have been diagnosed with dementia.You have had a seizure in the past 3 months or currently have seizures.You have health conditions that make it unsafe for you to have an MRI or iTBS treatment.
Research Study Groups:
This trial has the following groups:- Group 1: intermittent Theta Burst Stimulation
- Group 2: Placebo intermittent Theta Burst Stimulation
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are geriatric patients being accepted into this clinical research?
"The ages of 18 to 80 are the only patients that meet the requirements to participate in this clinical trial. Out of 100 trials, only 1238 patients over the age of 65 qualify."
Answered by AI
Who would be an eligible candidate to enroll in this research project?
"This trial is open to 48 patients who have previously suffered a stroke. All participants must be between 18 and 80 years old and meet the following cognitive impairment criteria: falling one standard deviation below age-normed expectations on two or more of the following measures: the RBANS index scores, DKEFS Color-Word Trials 3 and 4 scale scores, and/or WAIS-IV Digit Span scaled score. In addition, all patients must be medically stable, fluent in English, and have completed rehabilitation 2-10 years post-neurologic event."
Answered by AI
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