Clinical trial NCT04420793: Voice Changes During ECT
Official title: Voice Analysis in Patients Receiving Electroconvulsive Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unipolar Depression
Bipolar Depression
Bipolar Disorder, Manic
Keywords: VAPRE
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing electroconvulsive therapy (ECT) at the Medical University of South Carolina on an outpatient or inpatient basis.

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.


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.

Primary outcomes:
measure: Acoustic feature: zero crossing rate
timeFrame: Throughout a course of electroconvulsive therapy (ECT) which may last between 2 and 7 weeks.
measure: Acoustic feature: energy and entropy
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Acoustic feature: spectral centroid, spectral spread, spectral entropy, spectral flux, spectral rolloff
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Acoustic feature: Mel-Frequency Cepstral Coefficients, Chroma Vectors, and Chroma Deviation
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Linguistic features: question ratio, filler ratio, number ratio, type token ratio
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Linguistic features: verb frequency, noun frequency, pronoun frequency, adverb frequency, adjective frequency, particle frequency, conjunction frequency, pronoun frequency
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Linguistic features: standardized word entropy
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Linguistic features: Brunets index
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Linguistic features: Honores statistic
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Linguistic features: rate of speech
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Meta-features: fatigue
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Meta-features: audio quality
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Meta-features: sentiment
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Meta-features: stress
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Meta-features: gender
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Meta-features: accent
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Meta-features: length
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Meta-features: age
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Comparing the voice feature(s) with greatest statistically significant change to Patient Health Questionnaire (PHQ)-9 scores
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Acoustic Feature Specific Changes within and across sessions
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Linguistic Feature Specific Changes within and across sessions
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Meta-Feature Specific Changes within and across sessions
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Secondary outcomes:
measure: Acoustic Feature Specific Changes between sessions
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Linguistic Feature Specific Changes between sessions
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Meta-Feature Specific Changes between sessions
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Age
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: inpatient/outpatient status
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: gender
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: race
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Psychiatric diagnosis for ECT
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: PHQ-9 score at each session
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Psychiatric hospitalizations
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Past Psychiatric Medication Trials
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Current Psychiatric Medication Trials
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Classes of Current Psychiatric Medications
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Suicidal Ideation at ECT consult
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Past Suicide Attempts
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Psychiatric Review of Systems
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Family Psychiatric History
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Number of non-psychiatric medical diagnoses
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Past non-psychiatric medication trials
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Current non-psychiatric Medications
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Tobacco use history
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Tobacco use pack year
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Prior ECT treatment
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: total # of prior ECT treatments for response in the past
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Prior transcranial magnetic stimulation (TMS) treatment
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data: Prior response to ECT or TMS
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Patient Chart Review Data against voice features
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Generating ROC curves: stress
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Generating ROC curves: fatigue
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
measure: Generating ROC curves: sentiment
timeFrame: Throughout a course of electroconvulsive therapy which may last between 2 and 7 weeks.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Sean Christensen, MD
role: PRINCIPAL_INVESTIGATOR
References: