Voice Changes During ECT

NCT ID: NCT04420793

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-07
• Study Completion Date: 2021-02-17

Brief Summary

Depressed patients talk differently when they are depressed compared to when they are well. But it is hard to actually measure what the differences are. The study team will record voice samples from patients with mood disturbances, like depression, over the course of their receiving an electroconvulsive therapy (ECT) series. The study team will try and measure or quantify exactly what has changed in their speech and voice. The study team will choose ECT as it is one of the most effective and rapid treatment for depression. The study team will use a service provided by a company, NeuroLex, who has complex computer programs (artificial intelligence, AI) to analyze the voice samples.

Conditions

Unipolar Depression; Bipolar Depression; Bipolar Disorder, Manic

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

ECT and Voice Recorded Group

This is an add-on study of voice samples to be gathered during ECT clinical treatments. The ONLY research procedures are four tasks on an online form, one text task and three voice recording tasks. These voice recordings will take place in a private room on the 5th floor of the Institute of Psychiatry on the same day of a patient's ECT treatment. The questionnaire will take less than 10 minutes.

Questionnaire

Intervention Type: OTHER

3 voice recording tasks and 1 text entry task will be performed.

Interventions

Questionnaire

3 voice recording tasks and 1 text entry task will be performed.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Any candidate for electroconvulsive therapy who is about to initiate their ECT course at Medical University of South Carolina (MUSC) for a clinically indicated diagnosis
• Age 18 to 90 years old
• Able to speak and understand English
• Able to give consent to participate in the study

Exclusion Criteria

• Any medical condition that limits the ability to speak or speak clearly, for example a history of head and/or neck cancer, spinal cord injury affecting speech, amyotrophic lateral sclerosis, or those with absence of critical anatomical structures involved in speech.
• Any voice characteristics that may limit the ability to speak English clearly including speech impediments or heavy accents (as evidenced by the pronunciation of the English language in such a non-standard way that research staff). If study staff have significant difficulty understanding the participant's responses in conversation, this may warrant exclusion.
• Patients who are receiving ECT by involuntary order, by order of their guardian, or by a court order, as evidenced by patient report or brief chart review.
• Patients who elect to not receive their full course of ECT at MUSC.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean Christensen, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

00089198

Identifier Type: -

Identifier Source: org_study_id