Major Depressive DisorderNCT04621786
Electroconvulsive Therapy Amplitude Titration
A study testing Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation Interface in people with Major Depressive Disorder, run by University of New Mexico at 1 site in United States.
Trial summary
This study is focused on advancing ECT treatment for older adults with depressive disorders by refining neuromodulation stimulus parameters to improve efficacy and cognitive safety. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation Interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of major depressive disorder
- Clinical indications for ECT with right unilateral electrode placement
- Right-handed
- Age range between 50 and 80 years
Who cannot join
- Defined neurological or neurodegenerative disorder (e.g., traumatic brain injury, epilepsy, Alzheimer's disease)
- Other psychiatric conditions (e.g., schizophrenia, bipolar disorder)
- Current drug or alcohol use disorder (except for nicotine); and 4) contraindications to MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: Electroconvulsive Therapy Amplitude Titration for Improved Clinical Outcomes in Late Life Depression
This study is focused on advancing ECT treatment for older adults with depressive disorders by refining neuromodulation stimulus parameters to improve efficacy and cognitive safety.
Read the detailed description
Amplitude titration, as proposed in this current proposal, can reduce the variability related to fixed amplitude dosing and optimize clinical and cognitive outcomes. The goal of this project is to change standard ECT parameter selection from a fixed amplitude to an individualized and empirically determined amplitude. To achieve this goal, the investigators will focus on the relationship between amplitude titration and treatment-responsive changes in hippocampal neuroplasticity with RUL fixed amplitude ECT. Fixed amplitude ECT results in variable E-field or ECT dose. Over the course of an ECT series, the variable ECT dose will result in inconsistent changes in hippocampal neuroplasticity. In contrast, pre-translational investigations have demonstrated that amplitude titration results in a consistent E-field or ECT "dose". Seizure titration amplitudes (based on historic data, 233 to544mA) are below the amplitude range of FDA-approved ECT devices (500 to 900mA) and will require an adaptor to reduce the output amplitude (Investigational Device Exemption). Amplitude titration will also be below the hippocampal neuroplasticity threshold and insufficient for antidepressant response. The difference between RUL amplitude titration and RUL fixed amplitude (800mA) ECT will determine the degree of target engagement with the hippocampus. To illustrate, subjects with low amplitude titration of ~250 mA (800/250, high fixed/titration amplitude ratio) will have significant changes in hippocampal neuroplasticity. Subjects with high amplitude titration ~500mA (800/500, low fixed/titration ratio) will have minimal changes in hippocampal neuroplasticity. The relationship between amplitude titration and fixed amplitude hippocampal neuroplasticity will be used to develop the amplitude multiplier required for consistent and clinically effective ECT dosing.
- Conditions
- Major Depressive Disorder
- Being tested
- Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation Interface
- Keywords
- Electroconvulsive Therapy, Depressive Episode, Cognition
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation InterfaceDevice
The Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD-ECT Multi-Channel Stimulation Interface will reduce ECT current amplitude for amplitude-seizure titration.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | All subjects enrolled will receive amplitude titration for their first treatment. The remainder of the ECT series will be completed with traditional (800mA) pulse amplitude with right unilateral electrode placement. This investigation only includes the single open-label arm. Receives: Device: Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation Interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta Coefficient From Linear Regression of Amplitude-determined Seizure (Independent Variable) and Ebrain (Dependent Variable)
Electric field modeling is used to calculate Ebrain from the pre-ECT structural MRI. Ebrain is an individual's electric field strength (Volts/meter) per unit current (milliampere). To avoid confounds from the tissue boundary effects, Ebrain is calculated as the 90th percentile of maximal. Higher values (0.2 Volts/meter per milliampere) indicate that an individual receives a higher electric field strength per unit current. The Ebrain in this sample ranges from 0.1 to 0.19 Volts/meter per milliampere. Linear regression model assessed the relationship between amplitude-determined seizure (independent variable) and Ebrain (dependent variable) with beta coefficient and 95% confidence intervals.
Measured: First treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Mar 2021
- Primary completion1 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- The Zucker Hillside Hospital, National Institute of Mental Health (NIMH), The Mind Research Network, University of Texas Southwestern Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621786
- Sponsor's protocol ID
- MH125126
- Other IDs
- MH125126
- Status last verified
- Jan 2024
- First submitted
- 27 Oct 2020
- Last updated
- 11 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroconvulsive Therapy Amplitude Titration for Improved Clinical Outcomes in Late Life Depression
- ClinicalTrials.gov ID
- NCT04621786
- Acronym / sponsor ID
- MH125126
- Conditions
- Major Depressive Disorder
- Keywords
- Electroconvulsive Therapy, Depressive Episode, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- The Zucker Hillside Hospital, National Institute of Mental Health (NIMH), The Mind Research Network, University of Texas Southwestern Medical Center
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Posted 1 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is focused on advancing ECT treatment for older adults with depressive disorders by refining neuromodulation stimulus parameters to improve efficacy and cognitive safety.
Detailed description
Amplitude titration, as proposed in this current proposal, can reduce the variability related to fixed amplitude dosing and optimize clinical and cognitive outcomes. The goal of this project is to change standard ECT parameter selection from a fixed amplitude to an individualized and empirically determined amplitude. To achieve this goal, the investigators will focus on the relationship between amplitude titration and treatment-responsive changes in hippocampal neuroplasticity with RUL fixed amplitude ECT. Fixed amplitude ECT results in variable E-field or ECT dose. Over the course of an ECT series, the variable ECT dose will result in inconsistent changes in hippocampal neuroplasticity. In contrast, pre-translational investigations have demonstrated that amplitude titration results in a consistent E-field or ECT "dose". Seizure titration amplitudes (based on historic data, 233 to544mA) are below the amplitude range of FDA-approved ECT devices (500 to 900mA) and will require an adaptor to reduce the output amplitude (Investigational Device Exemption). Amplitude titration will also be below the hippocampal neuroplasticity threshold and insufficient for antidepressant response. The difference between RUL amplitude titration and RUL fixed amplitude (800mA) ECT will determine the degree of target engagement with the hippocampus. To illustrate, subjects with low amplitude titration of ~250 mA (800/250, high fixed/titration amplitude ratio) will have significant changes in hippocampal neuroplasticity. Subjects with high amplitude titration ~500mA (800/500, low fixed/titration ratio) will have minimal changes in hippocampal neuroplasticity. The relationship between amplitude titration and fixed amplitude hippocampal neuroplasticity will be used to develop the amplitude multiplier required for consistent and clinically effective ECT dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Device: Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation InterfaceAll subjects enrolled will receive amplitude titration for their first treatment. The remainder of the ECT series will be completed with traditional (800mA) pulse amplitude with right unilateral electrode placement. This investigation only includes the single open-label arm. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of major depressive disorder
- Clinical indications for ECT with right unilateral electrode placement
- Right-handed
- Age range between 50 and 80 years
Key exclusion criteria (3 listed)
- Defined neurological or neurodegenerative disorder (e.g., traumatic brain injury, epilepsy, Alzheimer's disease)
- Other psychiatric conditions (e.g., schizophrenia, bipolar disorder)
- Current drug or alcohol use disorder (except for nicotine); and 4) contraindications to MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation InterfaceThe Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD-ECT Multi-Channel Stimulation Interface will reduce ECT current amplitude for amplitude-seizure titration. | Device | Experimental arm |
Primary outcome
Beta Coefficient From Linear Regression of Amplitude-determined Seizure (Independent Variable) and Ebrain (Dependent Variable)
Time frame: First treatment
Electric field modeling is used to calculate Ebrain from the pre-ECT structural MRI. Ebrain is an individual's electric field strength (Volts/meter) per unit current (milliampere). To avoid confounds from the tissue boundary effects, Ebrain is calculated as the 90th percentile of maximal. Higher values (0.2 Volts/meter per milliampere) indicate that an individual receives a higher electric field strength per unit current. The Ebrain in this sample ranges from 0.1 to 0.19 Volts/meter per milliampere. Linear regression model assessed the relationship between amplitude-determined seizure (independent variable) and Ebrain (dependent variable) with beta coefficient and 95% confidence intervals.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation Interface in people with Major Depressive Disorder, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta Coefficient From Linear Regression of Amplitude-determined Seizure (Independent Variable) and Ebrain (Dependent Variable) (time frame: First treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.