## Protocol Section
### Identification Module
**NCT ID:** NCT06426602

**Brief Title:** mindBEAGLE: Unlocking Functional Communication for Patients With Disorders of Consciousness

**Official Title:** Unlocking Functional Communication for Patients With Disorders of Consciousness With Innovative Brain Computer Interface Technology

#### Organization Study ID Info
**ID:** STUDY23080022
#### Organization
**Class:** OTHER
**Full Name:** University of Pittsburgh
#### Secondary ID Infos
**Domain:** UPMC Beckwith Institute
**ID:** BECKW/12863
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-16
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** The Beckwith Institute

#### Lead Sponsor

**Class:** OTHER

**Name:** Amy Wagner

#### Responsible Party

**Investigator Affiliation:** University of Pittsburgh

**Investigator Full Name:** Amy Wagner

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this clinical trial is to test how effective the mindBEAGLE device is in allowing people who are unconscious (due to a brain injury or other condition) to communicate using brain waves to answer Yes/No questions. Participants will wear a cap that will be connected to a computer that measures brain waves, wrist bands that vibrate at different strengths, and ear phones that create different levels of loud tones and will be asked to associate Yes/No answers with the vibrations or tones. They will also be asked to "think about" moving different parts of their body to answer Yes or No. The mindBEAGLE device has already been proven effective for this kind of communication in a previous study, and the study team would like to trial it on a population of unconscious people who enter the UPMC Rehabilitation Institute to see if patients are able to be trained to use the device as part of their everyday inpatient rehabilitation until they are discharged, or until they are able to regain consciousness.

**Detailed Description:** The team's research reflects an integrated clinical and research team who will characterize and implement an aggressive and innovative approach using brain-computer interface (BCI) technology for Disorders of Consciousness (DoC) evaluation, prognostication, and rehabilitation care. The work proposed strives for equity in accessing healthcare systems and technology effectively, even among vulnerable individuals with profound levels of disability due to their DoC state.

The "gold-standard" for assessing cognitive capacity among patients with DoC relies on behavioral response observations and neuroimaging modalities. However, these approaches underestimate patients' capabilities. The current problem is that without other clinical data, rehabilitation teams rely solely on observable behavioral changes in patients' awareness of their environment in order to treat and improve communication. The project's challenge rests with implementing BCI focused assistive technology that identifies a unique and specific electrophysiological biomarker of cognitive and communication capacities that cannot be tapped using current clinical tools. If successful, this approach will allow clinical teams to initiate treatment and communication, avoiding therapeutic delays arising from traditional methods that require behavioral indicators needed to participate in functional communication.

The P300 wave is a positive deflection in the human event-related potential. It is most commonly elicited in an "oddball" paradigm when a subject detects an occasional "target" stimulus in a regular train of standard stimuli.

This project will compare standard awareness training methods used at the UPMC RI Brain Injury program with novel BCI research by using mindBEAGLE, a suite of P300 paradigms (vibrations, sound tones, and mental visualization) used for cognitive and communication assessment and treatment. European studies using the mindBEAGLE system with DoC patients reveal patients' cognitive and communication capabilities that impact current functional assessment and influence prognostication and recovery. The mindBEAGLE gives additional diagnostic data to enhance clinical neuroscience practice by showing reactions to stimuli that benefit from electroencephalogram (EEG) P300 use. However, clinical neuroscience implementation studies have not been conducted. Armed with more detailed and accurate assessments from this study, the investigators are confident that the clinical teams will be able to offer exciting rehabilitation treatments designed by UPMC RI treatment teams, patients, and families that leverage the mindBEAGLE interface for functional communication. Specifically, the EEG-based mindBEAGLE BCI suite will provide a practical platform for cognitive assessment of command following and a communication system for patients with DoC that will allow the research teams to offer more intensive, multidimensional rehabilitation treatments that meet the UPMC ideal of Life Changing Medicine.

### Conditions Module

**Conditions:**

- Disorders of Consciousness

**Keywords:**

- Coma

- Locked-in syndrome

- Vegetative state

- Unresponsive wakefulness syndrome

- Minimally conscious state

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Single arm Phase 2 experimental device efficacy clinical trial

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 15

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients identified as "disorders of consciousness" admitted to UPMC Rehabilitation Institute will be considered for the trial. As patients will not be able to communicate, health care proxy will provide consent. Participants will undergo 3 trials within a 7 day period (2-3 hours each ) to assess if they are responding to the device.

**Intervention Names:**

- Device: mindBEAGLE daily device use

**Label:** mindBEAGLE trial participants

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- mindBEAGLE trial participants

**Description:** If participants are considered responsive, they will continue to use the device daily for the remainder of their stay at inpatient rehab, or until they regain consciousness.

**Name:** mindBEAGLE daily device use

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** The ability to answer Yes/No questions at over above 60% accuracy using 1 of the following paradigms:

1. vibro-tactile (VT) stimulation with 3 tractors;
2. VT stimulation with 7 tractors;
3. motor imagery

**Measure:** Neural and Multisensory DOC mindBEAGLE Initial Classification Accuracy Assessment

**Time Frame:** 18 months

**Description:** Among DOC patients who pass initial classification assessment: ability to communicate yes/no questions at or above 60% accuracy with one of the two P300 paradigms.

mindBEAGLE P300 paradigm #1

1. Baseline - No response to yes/no questions
2. Change in baseline - Response to yes/no questions using mindBEAGLE

mindBEAGLE P300 paradigm #2

1. Baseline - 0% accuracy on yes/no questions
2. Change in baseline - 60% or higher in response to yes/no questions.

**Measure:** DOC mindBEAGLE Communication Assessment

**Time Frame:** 18 months

**Description:** Clinicians agree that mindBEAGLE is feasible to implement with DOC patients in the inpatient setting.

**Measure:** Acceptability of mindBEAGLE treatment by clinical staff.

**Time Frame:** Within 2 weeks Post-intervention

**Description:** Family/Caregivers of DOC patient agree that the mindBEAGLE was beneficial.

**Measure:** Acceptability of mindBEAGLE treatment by families of DOC patients.

**Time Frame:** Within 2 weeks Post-intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 18-50
* Medically able to tolerate Disorders of Consciousness (DoC) rehabilitation program as determined by UPMC Physicians
* Clinically assessed capacity for functional improvement in the rehabilitation environment
* Measuring improvements with pharmacological stimulation (using JFK Coma Recovery Scale)
* Electrophysiological prognostic testing confirming brain activity.

Exclusion Criteria:

* Coma
* Bilateral non-response with standard electrophysiological studies
* Medical instability
* Open scalp wound

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wagnerak@upmc.edu

**Name:** Amy K. Wagner, M.D.

**Phone:** 412-648-6666

**Role:** CONTACT

**Contact 2:**

**Email:** khill@pitt.edu

**Name:** Katherine Hill, Ph.D.

**Phone:** (412) 647-1310

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Pittsburgh

**Contacts:**

***Contact 1:***

- **Email:** schiappavj2@upmc.edu

- **Name:** Vince Schiappa, MS, ATP

- **Phone:** 412-647-1310

- **Role:** CONTACT

**Country:** United States

**Facility:** UPMC Center for Assistive Technology

**State:** Pennsylvania

**Zip:** 15213

**Location 2:**

**City:** Pittsburgh

**Contacts:**

***Contact 1:***

- **Email:** wagnerak@upmc.edu

- **Name:** Amy Wagner, M.D.

- **Phone:** 412-648-6666

- **Role:** CONTACT

**Country:** United States

**Facility:** UPMC Rehabilitation Institute

**State:** Pennsylvania

**Zip:** 15219

#### Overall Officials

**Official 1:**

**Affiliation:** University of Pittsburgh

**Name:** Amy Wagner, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Pittsburgh

**Name:** Katherine Hill, Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** It is possible that the investigators may use the information obtained from this study in other future research studies. All information disseminated to outside collaborators or entities will be done in a de-identified manner so as to mitigate a breach of confidentiality and protect PHI/PII. Data will be coded using unique identifying numbers that do not contain PII. Any links to PII will be kept locally but will not be disseminated to outside collaborators.

Any data shared with outside institutions or collaborators will be conducted under the guidelines of an approved data use agreement between the University of Pittsburgh and the collaborating entity. This includes any plans to publish published peer-reviewed manuscripts.

**IPD Sharing:** YES

### References Module

#### References

**Citation:** Kondziella D, Amiri M, Othman MH, Beghi E, Bodien YG, Citerio G, Giacino JT, Mayer SA, Lawson TN, Menon DK, Rass V, Sharshar T, Stevens RD, Tinti L, Vespa P, McNett M, Venkatasubba Rao CP, Helbok R; Curing Coma Campaign Collaborators. Incidence and prevalence of coma in the UK and the USA. Brain Commun. 2022 Sep 1;4(5):fcac188. doi: 10.1093/braincomms/fcac188. eCollection 2022.

**PMID:** 36132425

**Citation:** Godbolt AK, Deboussard CN, Stenberg M, Lindgren M, Ulfarsson T, Borg J. Disorders of consciousness after severe traumatic brain injury: a Swedish-Icelandic study of incidence, outcomes and implications for optimizing care pathways. J Rehabil Med. 2013 Sep;45(8):741-8. doi: 10.2340/16501977-1167.

**PMID:** 24002309

**Citation:** Mainali S, Aiyagari V, Alexander S, Bodien Y, Boerwinkle V, Boly M, Brown E, Brown J, Claassen J, Edlow BL, Fink EL, Fins JJ, Foreman B, Frontera J, Geocadin RG, Giacino J, Gilmore EJ, Gosseries O, Hammond F, Helbok R, Claude Hemphill J, Hirsch K, Kim K, Laureys S, Lewis A, Ling G, Livesay SL, McCredie V, McNett M, Menon D, Molteni E, Olson D, O'Phelan K, Park S, Polizzotto L, Javier Provencio J, Puybasset L, Venkatasubba Rao CP, Robertson C, Rohaut B, Rubin M, Sharshar T, Shutter L, Sampaio Silva G, Smith W, Stevens RD, Thibaut A, Vespa P, Wagner AK, Ziai WC, Zink E, I Suarez J; Curing Coma Campaign collaborators. Proceedings of the Second Curing Coma Campaign NIH Symposium: Challenging the Future of Research for Coma and Disorders of Consciousness. Neurocrit Care. 2022 Aug;37(1):326-350. doi: 10.1007/s12028-022-01505-3. Epub 2022 May 10. Erratum In: Neurocrit Care. 2022 Jun 17;:

**PMID:** 35534661

**Citation:** Torres-Saavedra PA, Winter KA. An Overview of Phase 2 Clinical Trial Designs. Int J Radiat Oncol Biol Phys. 2022 Jan 1;112(1):22-29. doi: 10.1016/j.ijrobp.2021.07.1700. Epub 2021 Aug 4.

**PMID:** 34363901

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000019965

- Term: Neurocognitive Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M6468

- Name: Consciousness Disorders

- Relevance: HIGH

- As Found: Disorders of Consciousness

- ID: M6356

- Name: Coma

- Relevance: LOW

- As Found: Unknown

- ID: M2155

- Name: Locked-In Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M21836

- Name: Neurocognitive Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T3491

- Name: Locked-in Syndrome

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003244

- Term: Consciousness Disorders

### Misc Info Module

- Version Holder: 2024-05-31
