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Behavioral Intervention

Cognitive Rehabilitation for Traumatic Brain Injury (TBPM Trial)

N/A

Waitlist Available

Led By Erica Weber, PhD

Research Sponsored by Kessler Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Steroid and/or benzodiazepine use

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a computer program designed to improve thinking skills in people with TBI.

Who is the study for?

This trial is for English-speaking individuals who have had a moderate-to-severe traumatic brain injury (TBI) at least one year ago and are struggling with strategic thinking skills. It's not suitable for those with other serious neurological conditions, major psychiatric disorders like bipolar or schizophrenia, a history of substance abuse, or current steroid/benzodiazepine use.

What is being tested?

The study is examining the effectiveness of a computer-based cognitive rehabilitation program aimed at enhancing thinking abilities in people who have suffered from TBI. Participants will engage with this digital therapy to see if it can help improve their memory and cognitive functions.

What are the potential side effects?

Since the intervention involves cognitive exercises on a computer, side effects may be minimal but could include eye strain, headache, or fatigue due to the mental effort required by these tasks.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently using steroids or benzodiazepines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to mid-intervention assessment #2 (8 weeks), mid-intervention assessment #3 (12 weeks), and final follow-up (16 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intervention Tolerability Assessment Scale

Recruitment rate percentage

Retention rate percentage

Secondary study objectives

Changes in strategic cognitive functions (performance on NIH EXAMINER)

Changes in time monitoring & time-based prospective memory

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExperimentalExperimental Treatment1 Intervention

The experimental group will receive treatment program designed to train strategic cognitive functions. Sessions will last 50 minutes and take place twice per week for 16 weeks.

Group II: Control groupActive Control1 Intervention

The control group will receive no active treatment and will be treated as a "no-contact control" group.

0 / 1Eligibility criteria met