80 Participants NeededMy employer runs this trial

SeeMe Protocol for Traumatic Brain Injury

SM
Overseen BySima Mofakham, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stony Brook University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called SeeMe, which uses advanced computer technology to detect small movements in people with Traumatic Brain Injury (TBI). Traditional methods often miss these tiny movements, leading to misdiagnosis of patients as unresponsive. The trial aims to demonstrate that SeeMe can better identify when patients begin to recover movement, potentially helping doctors predict recovery more accurately. Individuals who have experienced a TBI with loss of consciousness and can hear commands might be suitable for this study. As an unphased trial, participants have the opportunity to contribute to groundbreaking research that could enhance diagnosis and recovery predictions for future TBI patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to get a clear answer.

What prior data suggests that the SeeMe protocol is safe for patients with Traumatic Brain Injury?

Research has shown that the SeeMe protocol, which uses sound and computer technology, is generally well-tolerated by people with traumatic brain injury (TBI). Studies have found that similar methods, such as therapies using multiple senses, have positive effects without causing major side effects. These treatments help identify and improve small movements in TBI patients who appear unresponsive but still have a chance to recover.

Additionally, research on similar techniques, such as using rhythmic sounds, supports their safety and potential benefits for TBI recovery. Although specific data on the side effects of the SeeMe protocol is not available, sound therapy has been shown to be safe in other contexts. This suggests that the SeeMe protocol might also be safe for participants.12345

Why are researchers excited about this trial?

Researchers are excited about the SeeMe protocol because it offers a novel way to detect covert motor responses in patients with traumatic brain injury (TBI). Unlike current treatment options that focus primarily on managing symptoms and rehabilitation, the SeeMe protocol uses auditory stimulation to identify hidden motor activity, which might be overlooked otherwise. This innovative approach could lead to better understanding and monitoring of TBI recovery, providing insights that standard care doesn't currently offer. By establishing a "ground truth" with healthy volunteers and understanding the "noise floor" in sedated patients, the protocol aims to enhance the precision and sensitivity of detecting motor responses in TBI patients.

What evidence suggests that the SeeMe protocol is effective for detecting motor responses in TBI patients?

Research has shown that sound can aid in recovering movement after a traumatic brain injury (TBI). Some studies found that listening to rhythmic sounds improved abilities like walking and coordination. Other research suggests that sound-based methods enhance TBI patients' awareness of their surroundings. This type of sound therapy might activate the brain's natural healing processes, improving patients' responses to treatment. In this trial, the SeeMe protocol, an auditory stimulation method, will detect covert motor responses in TBI patients and could be promising for aiding recovery.12467

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older who have had a recent traumatic brain injury, lost consciousness with a GCS score of 8 or less when hospitalized, are medically stable, can hear commands (as confirmed by tests), and whose families agree to participate.

Inclusion Criteria

I am 22 or older and have had a serious brain injury.
* Documented loss of consciousness with a Glasgow Coma Scale (GCS) score less than or equal to 8 upon hospitalization
* Clinically stable as determined by the primary neurosurgery or ICU team
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SeeMe Auditory Stimulation protocol daily to detect covert motor responses

45 days
Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Periodic assessments

Long-term Follow-up

Assessment of long-term functional outcomes and consciousness recovery

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • SeeMe

Trial Overview

The study is testing 'SeeMe,' a computer system that uses cameras and sensors to detect tiny facial and hand movements in response to sounds. It aims to see if SeeMe can spot signs of awareness better than standard bedside exams in people recovering from severe brain injuries.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: TBI PatientsExperimental Treatment1 Intervention
Group II: Healthy Control CohortActive Control1 Intervention
Group III: Sedated/Paralyzed PatientsPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stony Brook University

Lead Sponsor

Trials
225
Recruited
41,700+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

SeeMe Protocol for Traumatic Brain Injury

Patients with Traumatic Brain Injury receiving the SeeMe Auditory Stimulation protocol daily to detect covert motor responses. Group II ...

Efficacy of Multimodal Sensory Therapy in Adult Acquired ...

Multimodal sensory therapy was mostly used as a coma arousal technique following traumatic brain injury, finding positive effects.

Auditory Stimulation of Slow‐Wave Sleep Promotes ...

In this proof-of-concept study, we delivered upCLAS to rats immediately after TBI to: (1) determine the efficacy, safety, specificity, and ...

(PDF) Effectiveness of auditory sensory stimulation on level ...

Results: According to the independent samples t-test, there was a significant increase in the level of consciousness on the third, fifth, and ...

The effects of Rhythmic Auditory Stimulation (RAS) on gait ...

The effects of Rhythmic Auditory Stimulation (RAS) on gait training for persons with Traumatic Brain Injury ; In Collections: Electronic Theses & Dissertations.

Computer vision detects covert voluntary facial movements ...

Many brain injury patients who appear unresponsive retain subtle, purposeful motor behaviors, signaling capacity for recovery.

Non-pharmacologic approaches to neurological ...

One crucial issue is which of NPNS is the best method for treatment of severe brain injury in terms of efficacy and safety. Actually, data are not enough to ...