We are excited to offer ExoMind in our Spakinect Treatment Database. ExoMind is an FDA-cleared medical device that uses transcranial electrical stimulation technology (ExoTMS) to support treatment of depression. 

To support patient safety, Spakinect has outlined recommended steps clinics should include in their internal procedures, and we have also provided a summary of our own protocol for how Spakinect Telehealth Providers respond if a patient reports active suicidal ideation or self-harm during an ExoMind Good Faith Evaluation (GFE).

General Recommendations for ExoMind:

• All clinics should have an established protocol for patients experiencing thoughts of suicide or self harm. 

• Treating providers should stay in the room with patients during the GFE evaluation.

• Patient should be monitored throughout the treatment by the treating provider. 

• If the treating provider will not remain in the room with the patient during an evaluation with Spakinect, the patient should be using a movable device such as an IPad or tablet device in order to be able to get staff with the provider present.   

• All patients should be evaluated on-site (at the clinic) for Exomind treatments.

• ExoMind will not be available as an At-Home-Visit treatment at this time. 

Spakinect’s Protocol for Patients Reporting Active Suicidal Ideation or Self-Harm During ExoMind Evaluations

Spakinect Telehealth Providers follow a structured safety protocol whenever a patient expresses active suicidal thoughts or self-harm intent during an ExoMind Good Faith Evaluation (GFE). This protocol is designed to protect patient safety and ensure immediate coordination with onsite clinic staff.

Why This Protocol Is Necessary

ExoMind is not recommended for patients experiencing psychiatric emergencies or imminent suicidal risk, as it does not provide rapid therapeutic effects.

Conducting GFEs onsite allows for immediate safety interventions should a crisis occur.

Coordinated action between Spakinect providers and clinic staff ensures the highest standard of care and patient safety.

What Spakinect Providers Will Do:

If a patient reports active suicidal ideation or self-harm, the provider will:

• Remain on the call and ensure the patient is not left alone.

• Speak calmly, assess the situation, and confirm the patient’s location inside the clinic.

• Perform a brief safety assessment, which includes determining whether the patient has a plan, access to means, or intent to harm themselves.

• Ask the patient to bring the telehealth device with them to the nearest onsite staff member.

• Initiate a warm handoff to clinic staff.

• Inform staff that the patient expressed suicidal thoughts and advise that the onsite team remain with the patient, follow their internal safety protocols, and contact emergency services (911) as appropriate.

• Assist the patient in contacting the Suicide & Crisis Lifeline (988).

• Stay connected via video until the patient is speaking with a crisis counselor using their personal phone (via call or text).

• End the visit only after confirming the patient is connected with 988 and onsite staff before ending the call.

• Defer treatment and complete all required clinical documentation.

Client Responsibilities

Because ExoMind evaluations occur only with patients physically located inside the clinic, the client is expected to:

• Have onsite staff present and available to assist immediately if a patient expresses suicidal ideation or self-harm.

• Maintain and follow an internal emergency response procedure for suicidal ideation, including when to call 911.

• Remain with the patient once notified and ensure continuous supervision until emergency services or appropriate follow-up care is secured.

• Ensure onsite staff can help the patient connect to crisis resources (e.g., 988) and provide any needed support.