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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 weeks
Treatment ~ Varies
Follow Up ~5 timepoints: week 1 before and after intervention, week 3 before and after intervention, week 5 as follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 timepoints: week 1 before and after intervention, week 3 before and after intervention, week 5 as follow-up for reporting.

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).

Find a Location

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

Media Library

intermittent Theta Burst Stimulation (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05117502 — N/A
Traumatic Brain Injury Research Study Groups: intermittent Theta Burst Stimulation, Placebo intermittent Theta Burst Stimulation
Traumatic Brain Injury Clinical Trial 2023: intermittent Theta Burst Stimulation Highlights & Side Effects. Trial Name: NCT05117502 — N/A
intermittent Theta Burst Stimulation (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05117502 — N/A

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
~2 spots leftby Apr 2025