Unipolar DepressionPhase 1NCT03895658
Title: Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST)
A Phase 1 study testing MRI, MagPro TMS stimulator and coil and Thymatron (R) System IV paired with 4X1 HDECT in people with Unipolar Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
Background: Electroconvulsive therapy (ECT) is used to treat people with severe depression. During ECT, the brain is given electric pulses that cause a seizure. Although it is effective, it can cause side effects, including memory loss. Researchers want to study a new way to give ECT called iLAST. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Unipolar Depression
- What is being tested?
- MRI, MagPro TMS stimulator and coil and Thymatron (R) System IV paired with 4X1 HDECT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2025to 26 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female, 22-70 years old
- Use of effective method of birth control for women of childbearing capacity. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the entire period of study participation (or until last clinical labs and rating) and have a negative pregnancy test at screening.
- DSM-5 diagnosis of major depressive disorder, confirmed by the structured clinical interview for the DSM 5 (SCID)
- Eligible for ECT, including patients receiving maintenance ECT
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document
- Subjects are willing and able to adhere to the intensive treatment schedule and all required study procedures
- On a stable dose of all psychotropic medications (no new medications, discontinuations or dose changes) for 4 weeks prior to baseline assessment and agreement not to change psychotropic medications during the experimental phase (Phase II) of the study, unless advised otherwise by the Investigator.
Who cannot join
- Pregnant or nursing women or women who plan to become pregnant during the study period.
- Current or recent (within the past 6 months) substance abuse or dependence (excluding nicotine and caffeine)
- Current serious medical illness, such as high blood pressure, diabetes, heart or lung disease that is not controlled by treatment and/or judged by the investigators to significantly affect the validity of the study or the safety of study participation.
- History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, concussion resulted in loss of consciousness or hospitalization, cranial metal implants that are not safety-compatible with magnetic resonance imaging (MRI) and/or electroconvulsive therapy (ECT), known structural brain lesion, devices that may be affected by TMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator, vagus nerve stimulator)
- Diagnosed with the following conditions (current unless otherwise stated):
- Any other current primary mood, anxiety, or psychotic disorder
Show all 37Show fewer
- Depression secondary to a general medical condition, or substance-induced
- Psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in the current episode
- Eating disorder (current or within the past year)
- Obsessive compulsive disorder (current or within the past year)
- Post-traumatic stress disorder (current or within the past year)
- ADHD (currently being treated)
- Subjects meeting criteria of any psychiatric illness based upon DSM-5, which in the judgment of the Investigator, may hinder the subjects in completing the procedures required by the study protocol
- Actively suicidal
- Increased risk of complications from seizures, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication at a dose that significantly alters seizure threshold, as determined by the investigators.
- Subjects with a clinically defined neurological disorder including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure
- Space occupying brain lesion
- History of stroke
- Transient ischemic attack within two years
- Cerebral aneurysm
- Dementia
- Mini Mental Status Exam (MMSE) score < 24
- Parkinson s disease
- Huntington s disease
- Multiple sclerosis
- Subjects with any of the following treatment histories:
- Failure to respond to ECT treatment (i.e., consistent with ATHF confidence level 3 or higher) in this or any previous episode
- Lifetime history of treatment with Deep Brain Stimulation or Vagus Nerve Stimulation
- Use of any investigational drug or device within 4 weeks of the screening
- Subjects with:
- intracranial metal that are not safety-compatible with MRI and/or ECT, and/or
- extracranial metal, that are not safety-compatible with MRI and/or ECT
- A history of claustrophobia that may make it difficult for the patient to complete the MRI study or may adversely impact the quality of the images or the interpretation of the findings
- Current visual, auditory, or motor impairment that compromises ability to complete evaluations
- Positive HIV test
- NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST)
Background:
Electroconvulsive therapy (ECT) is used to treat people with severe depression. During ECT, the brain is given electric pulses that cause a seizure. Although it is effective, it can cause side effects, including memory loss. Researchers want to study a new way to give ECT called iLAST.
Read more
Objective:
To see if iLAST is safe and feasible in treating depression.
Eligibility:
People ages 22 70 years old who have major depressive disorder and are eligible for ECT
Design:
Participants will be screened under protocol 01-M-0254. This includes:
Medical and psychiatric history and exam
Blood and urine tests
Participants will be inpatients at the Clinical Center. They study has 3 phases and will last up to 20 weeks.
Phase I will last 1 week. It includes:
MRI: Participants will lie in a scanner that takes pictures of the body
MEG: A cone over the participant s head will record brain activity.
TMS: A wire coil placed on the participant s scalp will produce an electrical current to affect brain activity.
SEP: An electrode on the participant s wrist will give a small electrical shock to test nerve function.
Phase II will last 2 and a half weeks. It includes:
Seven sessions of iLAST under general anesthesia. Participants may also get standard ECT.
EEG: A small electrode placed on the participant s scalp will record brain waves.
Interviews about mood, symptoms, and side effects. Participants facial expressions may be video recorded.
TMS
Phase III will last at least 1 week. It will include:
MRI
EEG
TMS
MEG
Standard ECT if needed. Participants will have sessions every other day, 3 times a week.
Read the detailed description
Objective
Despite advances in antidepressant interventions, none has replaced electroconvulsive therapy (ECT) in its acute efficacy and spectrum of action in severely depressed patients, including in psychotic depression, catatonia, and acutely suicidal patients. However, ECT carries a risk of significant adverse effects including cognitive and physiological side effects, some of which can be long term. The side effects are thought to be related to stimulation of brain areas beyond those implicated in depression, so called non-target regions. While these advances have improved the safety and tolerability of seizure therapy, a risk of cognitive side effects remains, and none of the currently used procedures individualize the current amplitude for each patient despite knowledge that anatomical variation significantly impacts the strength of the current delivered to the brain. We propose a first-in-human safety and feasibility study of this approach (termed individualized low amplitude seizure therapy , or iLAST). iLAST introduces three areas of improvement over conventional ECT:
- use of a multi-electrode array to selectively target different regions of the brain coupled with computational electric field modeling on an individual patient basis to examine the current flow in the brain.
- an alternative dosing strategy in which the stimulus is titrated in the current amplitude domain.
- use of high-density EEG electrodes that are weaved into the multi-stimulation electrode array so that topographical ictal EEG is recorded. As mandated by the US FDA, a first in human (FIH) study is a type of study in which a device for a specific indication is evaluated for the first time in human subjects. We propose a FIH study of iLAST in 10 subjects. If safety and feasibility of iLAST are supported, this could lead to the development of a practical and safer alternative to ECT that could be rapidly disseminated through modification of ECT devices already cleared by the FDA, lowering regulatory barriers and development cost. If the aims are not supported, this would provide further support that development of the magnetic approach to seizure therapy is warranted.
The primary aim of the current protocol is to evaluate the safety and feasibility of iLAST in 10 adults with major depressive episode (unipolar) eligible for ECT. We hypothesize that iLAST will result in superior neurocognitive outcomes than conventional ECT. In addition, we will evaluate the feasibility of alternative methods to individualize the pulse amplitude. The approach to individualizing pulse amplitude is to apply trains of pulses of increasing amplitude until a seizure is induced. To be practical in the clinical setting, the motor threshold (MT) procedure will be completed rapidly to minimize time under anesthesia. To this end, we will evaluate a rapid- estimation motor thresholding algorithm under anesthesia. This will allow us to determine the relationships among measured amplitude-titrated seizure threshold (STa), measured MT, and simulated MT derived from electric field modeling. Our hypothesis is that both measured and simulated MT are correlated with STa, thus providing a clinically useful predictor of current amplitude necessary to perform seizure therapy under the time-constraints of anesthesia.
Study Population
The study will consist of 10 individuals between 22 and 70 years old, with a major depressive disorder.
Study Design
This is a within-subject safety and feasibility study that comprises three phases. Phase I includes medication taper (as clinically indicated), and baseline assessments.
In Phase II, patients will receive the 7 ultrabrief pulse width (0.25 ms) seizure therapy conditions. As per conventional ECT treatment schedule, treatments will be delivered on a 3 per week schedule. This will be followed by a repeat of the baseline assessment.
On each experimental condition day, patients will undergo a number of procedures to assess clinical status and safety. Post procedure acute battery assessments will include: a) side effect questionnaire and b) neurocognitive battery.
In Phase III, patients will be offered routine clinical management consisting of a conventional ECT course (typically 6-12 treatments) based on clinical need. Patients may receive optional post- course measures including: clinical rating scales, neurocognitive testing, neuroimaging, and a neuroplasticity battery.
Outcome Measures
Primary Outcome measures: successful seizure induction as measured by topographical EEG and motor manifestations, vital signs, ECG, subjective side effect scale, and adverse events/significant adverse events.
Secondary Outcome measures: Neurocognitive battery known to be sensitive to the cognitive effects of ECT, with alternative versions to avoid practice effects; and, Amplitude-titrated seizure threshold (STa), measured electrical MT, and simulated MT derived from realistic head modeling.
- Conditions
- Unipolar Depression
- Being tested
- MRI, MagPro TMS stimulator and coil, Thymatron (R) System IV paired with 4X1 HDECT
- Keywords
- Brain Stimulation, Neurocognitive, Major Depressive Disorder (MDD)
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Structural and functional neuroimaging pre and post ECT treatment
MagPro TMS stimulator and coilDevice
Transcranial magnetic stimulation measurements of cortical excitability pre and post ECT treatment
Thymatron (R) System IV paired with 4X1 HDECTDevice
Multi-Channel Stimulation Interface (Model 4X1 HDECT)
| Study group | Role | What they receive |
|---|---|---|
| ECT | Experimental | ECT treatment, Within subject cross-over Receives: Device: Thymatron (R) System IV paired with 4X1 HDECT |
| MRI | Experimental | Structural and functional neuroimaging pre and post ECT treatment Receives: Device: MRI |
| TMS | Experimental | Transcranial magnetic stimulation measurements of cortical excitability pre and post ECT treatment Receives: Device: MagPro TMS stimulator and coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful seizure induction as measured by topographical EEG and motor manifestations, vital signs, ECG, subjective side effect scale, and adverse events/significant adverse events
Successful seizure induction as measured by topographical EEG and motor manifestations, vital signs, ECG, subjective side effect scale, and adverse events/significant adverse events
Measured: ongoing
Secondary outcomes (1)
Neurocognitive battery known to be sensitive to cognitive effects of ECT, with alternative versions to avoid practice effects; Amplitude-titrated seizure threshold (STa), measured electrical motor threshold (MT), and simulated MT derived from re...
Neurocognitive battery known to be sensitive to cognitive effects of ECT, with alternative versions to avoid practice effects; Amplitude-titrated seizure threshold (STa), measured electrical motor threshold (MT), and simulated MT derived from realistic head modeling.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start26 Feb 2025
- Primary completion26 Feb 2025
- Study completion26 Feb 2025
Why it stopped: PI leaving NIH.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Unipolar DepressionStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sarah H Lisanby, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895658
- Sponsor's protocol ID
- 190073
- Other IDs
- 19-M-0073
- Status last verified
- Feb 2025
- First submitted
- 28 Mar 2019
- Last updated
- 27 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD that underlie a publication, e.g. participant clinical characteristics, study outcome data including adverse events, results of depression scale score and cognitive testing, biomarker data, may be shared with collaborating laboratories at NIH or outside of NIH and/or submitted to NIH-designated repositories and databases if consent for sharing was obtained. Data will be stripped of identifiers and may be coded ( de-identified ) or unlinked from an identifying code ( anonymized ). When coded data is shared, the key to the code will not be provided to collaborators, but will remain at NIH.
Publications
Luber B, Nobler MS, Moeller JR, Katzman GP, Prudic J, Devanand DP, Dichter GS, Sackeim HA. Quantitative EEG during seizures induced by electroconvulsive therapy: relations to treatment modality and clinical features. II. Topographic analyses. J ECT. 2000 Sep;16(3):229-43. doi: 10.1097/00124509-200009000-00003.
PubMed 11005044Lisanby SH, Maddox JH, Prudic J, Devanand DP, Sackeim HA. The effects of electroconvulsive therapy on memory of autobiographical and public events. Arch Gen Psychiatry. 2000 Jun;57(6):581-90. doi: 10.1001/archpsyc.57.6.581.
PubMed 10839336Lisanby SH, Luber B, Schlaepfer TE, Sackeim HA. Safety and feasibility of magnetic seizure therapy (MST) in major depression: randomized within-subject comparison with electroconvulsive therapy. Neuropsychopharmacology. 2003 Oct;28(10):1852-65. doi: 10.1038/sj.npp.1300229.
PubMed 12865903
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST)
- ClinicalTrials.gov ID
- NCT03895658
- Acronym / sponsor ID
- 190073
- Conditions
- Unipolar Depression
- Keywords
- Brain Stimulation, Neurocognitive, Major Depressive Disorder (MDD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI leaving NIH.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 26 Feb 2025 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
Electroconvulsive therapy (ECT) is used to treat people with severe depression. During ECT, the brain is given electric pulses that cause a seizure. Although it is effective, it can cause side effects, including memory loss. Researchers want to study a new way to give ECT called iLAST.
Objective:
To see if iLAST is safe and feasible in treating depression.
Eligibility:
People ages 22 70 years old who have major depressive disorder and are eligible for ECT
Design:
Participants will be screened under protocol 01-M-0254. This includes:
Medical and psychiatric history and exam
Blood and urine tests
Participants will be inpatients at the Clinical Center. They study has 3 phases and will last up to 20 weeks.
Phase I will last 1 week. It includes:
MRI: Participants will lie in a scanner that takes pictures of the body
MEG: A cone over the participant s head will record brain activity.
TMS: A wire coil placed on the participant s scalp will produce an electrical current to affect brain activity.
SEP: An electrode on the participant s wrist will give a small electrical shock to test nerve function.
Phase II will last 2 and a half weeks. It includes:
Seven sessions of iLAST under general anesthesia. Participants may also get standard ECT.
EEG: A small electrode placed on the participant s scalp will record brain waves.
Interviews about mood, symptoms, and side effects. Participants facial expressions may be video recorded.
TMS
Phase III will last at least 1 week. It will include:
MRI
EEG
TMS
MEG
Standard ECT if needed. Participants will have sessions every other day, 3 times a week.
Detailed description
Objective
Despite advances in antidepressant interventions, none has replaced electroconvulsive therapy (ECT) in its acute efficacy and spectrum of action in severely depressed patients, including in psychotic depression, catatonia, and acutely suicidal patients. However, ECT carries a risk of significant adverse effects including cognitive and physiological side effects, some of which can be long term. The side effects are thought to be related to stimulation of brain areas beyond those implicated in depression, so called non-target regions. While these advances have improved the safety and tolerability of seizure therapy, a risk of cognitive side effects remains, and none of the currently used procedures individualize the current amplitude for each patient despite knowledge that anatomical variation significantly impacts the strength of the current delivered to the brain. We propose a first-in-human safety and feasibility study of this approach (termed individualized low amplitude seizure therapy , or iLAST). iLAST introduces three areas of improvement over conventional ECT:
- use of a multi-electrode array to selectively target different regions of the brain coupled with computational electric field modeling on an individual patient basis to examine the current flow in the brain.
- an alternative dosing strategy in which the stimulus is titrated in the current amplitude domain.
- use of high-density EEG electrodes that are weaved into the multi-stimulation electrode array so that topographical ictal EEG is recorded. As mandated by the US FDA, a first in human (FIH) study is a type of study in which a device for a specific indication is evaluated for the first time in human subjects. We propose a FIH study of iLAST in 10 subjects. If safety and feasibility of iLAST are supported, this could lead to the development of a practical and safer alternative to ECT that could be rapidly disseminated through modification of ECT devices already cleared by the FDA, lowering regulatory barriers and development cost. If the aims are not supported, this would provide further support that development of the magnetic approach to seizure therapy is warranted.
The primary aim of the current protocol is to evaluate the safety and feasibility of iLAST in 10 adults with major depressive episode (unipolar) eligible for ECT. We hypothesize that iLAST will result in superior neurocognitive outcomes than conventional ECT. In addition, we will evaluate the feasibility of alternative methods to individualize the pulse amplitude. The approach to individualizing pulse amplitude is to apply trains of pulses of increasing amplitude until a seizure is induced. To be practical in the clinical setting, the motor threshold (MT) procedure will be completed rapidly to minimize time under anesthesia. To this end, we will evaluate a rapid- estimation motor thresholding algorithm under anesthesia. This will allow us to determine the relationships among measured amplitude-titrated seizure threshold (STa), measured MT, and simulated MT derived from electric field modeling. Our hypothesis is that both measured and simulated MT are correlated with STa, thus providing a clinically useful predictor of current amplitude necessary to perform seizure therapy under the time-constraints of anesthesia.
Study Population
The study will consist of 10 individuals between 22 and 70 years old, with a major depressive disorder.
Study Design
This is a within-subject safety and feasibility study that comprises three phases. Phase I includes medication taper (as clinically indicated), and baseline assessments.
In Phase II, patients will receive the 7 ultrabrief pulse width (0.25 ms) seizure therapy conditions. As per conventional ECT treatment schedule, treatments will be delivered on a 3 per week schedule. This will be followed by a repeat of the baseline assessment.
On each experimental condition day, patients will undergo a number of procedures to assess clinical status and safety. Post procedure acute battery assessments will include: a) side effect questionnaire and b) neurocognitive battery.
In Phase III, patients will be offered routine clinical management consisting of a conventional ECT course (typically 6-12 treatments) based on clinical need. Patients may receive optional post- course measures including: clinical rating scales, neurocognitive testing, neuroimaging, and a neuroplasticity battery.
Outcome Measures
Primary Outcome measures: successful seizure induction as measured by topographical EEG and motor manifestations, vital signs, ECG, subjective side effect scale, and adverse events/significant adverse events.
Secondary Outcome measures: Neurocognitive battery known to be sensitive to the cognitive effects of ECT, with alternative versions to avoid practice effects; and, Amplitude-titrated seizure threshold (STa), measured electrical MT, and simulated MT derived from realistic head modeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ECT | Experimental | Device: Thymatron (R) System IV paired with 4X1 HDECTECT treatment, Within subject cross-over |
| MRI | Experimental | Device: MRIStructural and functional neuroimaging pre and post ECT treatment |
| TMS | Experimental | Device: MagPro TMS stimulator and coilTranscranial magnetic stimulation measurements of cortical excitability pre and post ECT treatment |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male and female, 22-70 years old
- Use of effective method of birth control for women of childbearing capacity. Women who are able to get pregnant must be willing to use at least one form of effective birth control during the entire period of study participation (or until last clinical labs and rating) and have a negative pregnancy test at screening.
- DSM-5 diagnosis of major depressive disorder, confirmed by the structured clinical interview for the DSM 5 (SCID)
- Eligible for ECT, including patients receiving maintenance ECT
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document
Key exclusion criteria (37 listed)
- Pregnant or nursing women or women who plan to become pregnant during the study period.
- Current or recent (within the past 6 months) substance abuse or dependence (excluding nicotine and caffeine)
- Current serious medical illness, such as high blood pressure, diabetes, heart or lung disease that is not controlled by treatment and/or judged by the investigators to significantly affect the validity of the study or the safety of study participation.
- History of seizure except those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study), history of epilepsy in self or first degree relatives, stroke, brain surgery, concussion resulted in loss of consciousness or hospitalization, cranial metal implants that are not safety-compatible with magnetic resonance imaging (MRI) and/or electroconvulsive therapy (ECT), known structural brain lesion, devices that may be affected by TMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain stimulator, vagus nerve stimulator)
- Diagnosed with the following conditions (current unless otherwise stated):
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 |
|---|---|---|
| MRIStructural and functional neuroimaging pre and post ECT treatment | Device | MRI |
| MagPro TMS stimulator and coilTranscranial magnetic stimulation measurements of cortical excitability pre and post ECT treatment | Device | TMS |
| Thymatron (R) System IV paired with 4X1 HDECTMulti-Channel Stimulation Interface (Model 4X1 HDECT) | Device | ECT |
Primary outcome
Successful seizure induction as measured by topographical EEG and motor manifestations, vital signs, ECG, subjective side effect scale, and adverse events/significant adverse events
Time frame: ongoing
Successful seizure induction as measured by topographical EEG and motor manifestations, vital signs, ECG, subjective side effect scale, and adverse events/significant adverse events
1 secondary outcome
Neurocognitive battery known to be sensitive to cognitive effects of ECT, with alternative versions to avoid practice effects; Amplitude-titrated seizure threshold (STa), measured electrical motor threshold (MT), and simulated MT derived from re...
Time frame: Ongoing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Background: PubMed 11005044Luber B, Nobler MS, Moeller JR, Katzman GP, Prudic J, Devanand DP, Dichter GS, Sackeim HA. Quantitative EEG during seizures induced by electroconvulsive therapy: relations to treatment modality and clinical features. II. Topographic analyses. J ECT. 2000 Sep;16(3):229-43. doi: 10.1097/00124509-200009000-00003.
- Background: PubMed 10839336Lisanby SH, Maddox JH, Prudic J, Devanand DP, Sackeim HA. The effects of electroconvulsive therapy on memory of autobiographical and public events. Arch Gen Psychiatry. 2000 Jun;57(6):581-90. doi: 10.1001/archpsyc.57.6.581.
- Background: PubMed 12865903Lisanby SH, Luber B, Schlaepfer TE, Sackeim HA. Safety and feasibility of magnetic seizure therapy (MST) in major depression: randomized within-subject comparison with electroconvulsive therapy. Neuropsychopharmacology. 2003 Oct;28(10):1852-65. doi: 10.1038/sj.npp.1300229.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD that underlie a publication, e.g. participant clinical characteristics, study outcome data including adverse events, results of depression scale score and cognitive testing, biomarker data, may be shared with collaborating laboratories at NIH or outside of NIH and/or submitted to NIH-designated repositories and databases if consent for sharing was obtained. Data will be stripped of identifiers and may be coded ( de-identified ) or unlinked from an identifying code ( anonymized ). When coded data is shared, the key to the code will not be provided to collaborators, but will remain at NIH.
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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.
Sarah H Lisanby, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRI, MagPro TMS stimulator and coil and Thymatron (R) System IV paired with 4X1 HDECT in people with Unipolar Depression, run by National Institute of Mental Health (NIMH) 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 7 inclusion and 37 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: withdrawn, as of the sponsor's last update on 27 Feb 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Successful seizure induction as measured by topographical EEG and motor manifestations, vital signs, ECG, subjective side effect scale, and adverse events/significant adverse events (time frame: ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03895658, which also lists 3 linked publications.
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 27 Feb 2025.