Depressive DisorderNCT02897843
The Effect of Transcranial Direct Current Stimulation on Cognitive Side Effects of Electroconvulsive Therapy
A study testing transcranial magnetic stimulation in people with Depressive Disorder, run by Northwell Health at 1 site in United States.
Trial summary
Electroconvulsive therapy (ECT) is an effective treatment for a variety of psychiatric disorders. However, despite continued advances in ECT technique, neurocognitive dysfunction continues to be a frequent adverse effect. Declarative memory and less so selective memory are often impaired after an ECT course. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2017to 19 Apr 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects 18 years of age and above;
- Diagnosis of Major Depression confirmed by Structured Clinical Interview for Diagnostic and Statistical Manual IV (SCID-IV) interview;
- ECT is clinically indicated;
- Patient is competent to provide informed consent;
Who cannot join
- Lifetime DSM-IV diagnosis of schizophrenia, schizoaffective disorder or any other primary psychotic disorder as well as Bipolar Disorder, as defined in the DSM-IV;
- Current diagnosis of delirium or any major or minor neurocognitive disorder;
- Diagnosis of Mental Retardation;
- Limited English proficiency;
- Baseline Mini Mental State Exam (MMSE) score < 21 or a total score falling two standard deviations below the age- and education-adjusted mean, whichever is less;
- Skin lesions at the site of electrodes and any documented head or neck dermatological disorder;
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- Person with any kind of neurostimulator, an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system;
- Any active general medical condition or central nervous system (CNS) disease which can affect cognition or response to treatment;
- A history of medication-resistant epilepsy in the family, and/or past history of seizures or unexplained spells of loss of consciousness during the previous 36 months
- Current (within the past three months) diagnosis of active substance dependence, or active substance abuse within the past week, as determined by interview and chart review.
- Active suicidal ideation, as measured by scores of 3 or more on item 3 of the HRSD;
- ECT within six months;
- The presence of any known or suspected contraindication to methohexital including but not limited to known allergic reactions to these agents, uncontrolled hypertension, arrhythmia, severe coronary artery disease and porphyria;
- Pregnancy as determined by interview and blood work done for ECT workup;
- Women who are breastfeed as determined by self-report;
- Status 4 or greater according to the criteria of the American Society of Anesthesiologists.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Zucker Hillside Hospital
Glen Oaks, New York, 11004
About this study
Electroconvulsive therapy (ECT) is an effective treatment for a variety of psychiatric disorders. However, despite continued advances in ECT technique, neurocognitive dysfunction continues to be a frequent adverse effect. Declarative memory and less so selective memory are often impaired after an ECT course. Immediate memory, however, is broadly preserved. It is hypothesized that memory impairments are due to ECT induced disruptions on long term potentiation as well as in cerebral flux and glutamatergic and cholinergic systems. Different pharmacological agents for the treatment of ECT induced cognitive dysfunction have been tried. Agents such as opioids, vasopressin, neuropeptides, cholinergic agents, thyroid hormone, and stimulants have been used with equivocal results, and no controlled studies showed clear efficacy.
Transcranial direct current stimulation (tDCS) is a non-invasive, painless brain stimulation treatment that uses direct electrical currents to stimulate specific parts of the brain. Electrical currents are applied constantly at low intensities (1-2 mA) over a long period, usually in minutes (5-30 minutes), to achieve changes in cortical excitability by influencing spontaneous neural activity. There are two types of stimulation with tDCS: anodal and cathodal stimulation. Anodal stimulation acts to excite neuronal activity while cathodal stimulation inhibits or reduces neuronal activity. Several studies demonstrated moderate to strong effect sizes of tDCS in various neurocognitive and neuropsychiatric settings. Majority of studies show positive effects of tDCS on cognitive functioning among healthy volunteers and subjects with neurological or psychiatric conditions. Beneficial effects of online stimulation applied over the left dorsolateral prefrontal cortex have been reported for working memory, attention and information processing in depressed patients. To the investigators' knowledge no studies have evaluated the potential efficacy of tDCS for the prevention of ECT induced cognitive adverse effects.
In the current study, the investigators propose a double blind, randomized controlled trial to test the use of tDCS as a strategy to prevent or mitigate the memory impairments frequently associated with an ECT course.
Read the detailed description
This is a prospective, random assignment, double blind, parallel group study with an adaptive design comparing the efficacy of tDCS performed during the course of ECT to that of sham tDCS in patients with a major depressive episode being treated with ECT. The investigators intend to recruit patients who are scheduled to receive an acute course of ECT. Patients who are able and willing to provide written informed consent, and who meet study criteria when screened, will be randomly assigned on a 1:1 ratio to receive a course of real tDCS or sham tDCS. Subjects will receive a standard acute course of bifrontal ECT (3X/week) and depressive symptomatology will be monitored with the Hamilton Rating Scale for Depression (HRSD-24) before each treatment.
The primary outcome will be change in cognition from baseline to end of study. The investigators will monitor cognitive changes before and after each ECT treatment, at the end of the treatment course and two months after the last treatment.
Secondary outcome will be the number of treatments needed to achieve remission. Remission is defined as two consecutive Hamilton Rating Scale for Depression (HRSD) scores <= 10, and HRSD total score does not change > 3 points or remains < 6 at the last two consecutive treatments. In addition, the investigators will collect data on other treatment parameters such as seizure duration, electroencephalogram (EEG) morphology as well as hemodynamic changes.
- Conditions
- Depressive Disorder
- Being tested
- transcranial magnetic stimulation, sham tDCS
- Keywords
- Electroconvulsive Therapy, Transcranial Direct Current Stimulation, cognition
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationDevice
tDCS stimulation will involve ten 20 minute stimulations daily, characterized by 2 milliamps (mA) anode over the left dorsolateral prefrontal cortex (DLPFC), with the cathode placed over the right suborbital region.
sham tDCSDevice
sham tDCS
| Study group | Role | What they receive |
|---|---|---|
| sham tDCS | Sham comparator | Sham tDCS sessions will last 20 minutes, but a real stimulus of 2 milliamps (mA) will be applied only during the first minute Receives: Device: sham tDCS |
| tDCS | Experimental | 20 minute tDCS sessions Receives: Device: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in memory function
Change in memory function will be determined by a factor analysis of all memory tests
Measured: up to three months
Secondary outcomes (1)
Number of ECT treatments needed to achieve remission
Remission is defined as two consecutive Hamilton Rating Scale for Depression (HRSD) scores <= 10, and HRSD total score does not change > 3 points or remains < 6 at the last two consecutive ECT treatments.
Measured: up to three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start16 Feb 2017
- Primary completion11 Oct 2018
- Study completion19 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael Braga, Northwell Health
- Investigators
- Raphael Braga, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897843
- Sponsor's protocol ID
- HS16-0241
- Status last verified
- May 2019
- First submitted
- 2 Aug 2016
- Last updated
- 22 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Direct Current Stimulation on Cognitive Side Effects of Electroconvulsive Therapy
- ClinicalTrials.gov ID
- NCT02897843
- Acronym / sponsor ID
- HS16-0241
- Conditions
- Depressive Disorder
- Keywords
- Electroconvulsive Therapy, Transcranial Direct Current Stimulation, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 13 Sep 2016 (estimated)
- 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.
Electroconvulsive therapy (ECT) is an effective treatment for a variety of psychiatric disorders. However, despite continued advances in ECT technique, neurocognitive dysfunction continues to be a frequent adverse effect. Declarative memory and less so selective memory are often impaired after an ECT course. Immediate memory, however, is broadly preserved. It is hypothesized that memory impairments are due to ECT induced disruptions on long term potentiation as well as in cerebral flux and glutamatergic and cholinergic systems. Different pharmacological agents for the treatment of ECT induced cognitive dysfunction have been tried. Agents such as opioids, vasopressin, neuropeptides, cholinergic agents, thyroid hormone, and stimulants have been used with equivocal results, and no controlled studies showed clear efficacy.
Transcranial direct current stimulation (tDCS) is a non-invasive, painless brain stimulation treatment that uses direct electrical currents to stimulate specific parts of the brain. Electrical currents are applied constantly at low intensities (1-2 mA) over a long period, usually in minutes (5-30 minutes), to achieve changes in cortical excitability by influencing spontaneous neural activity. There are two types of stimulation with tDCS: anodal and cathodal stimulation. Anodal stimulation acts to excite neuronal activity while cathodal stimulation inhibits or reduces neuronal activity. Several studies demonstrated moderate to strong effect sizes of tDCS in various neurocognitive and neuropsychiatric settings. Majority of studies show positive effects of tDCS on cognitive functioning among healthy volunteers and subjects with neurological or psychiatric conditions. Beneficial effects of online stimulation applied over the left dorsolateral prefrontal cortex have been reported for working memory, attention and information processing in depressed patients. To the investigators' knowledge no studies have evaluated the potential efficacy of tDCS for the prevention of ECT induced cognitive adverse effects.
In the current study, the investigators propose a double blind, randomized controlled trial to test the use of tDCS as a strategy to prevent or mitigate the memory impairments frequently associated with an ECT course.
Detailed description
This is a prospective, random assignment, double blind, parallel group study with an adaptive design comparing the efficacy of tDCS performed during the course of ECT to that of sham tDCS in patients with a major depressive episode being treated with ECT. The investigators intend to recruit patients who are scheduled to receive an acute course of ECT. Patients who are able and willing to provide written informed consent, and who meet study criteria when screened, will be randomly assigned on a 1:1 ratio to receive a course of real tDCS or sham tDCS. Subjects will receive a standard acute course of bifrontal ECT (3X/week) and depressive symptomatology will be monitored with the Hamilton Rating Scale for Depression (HRSD-24) before each treatment.
The primary outcome will be change in cognition from baseline to end of study. The investigators will monitor cognitive changes before and after each ECT treatment, at the end of the treatment course and two months after the last treatment.
Secondary outcome will be the number of treatments needed to achieve remission. Remission is defined as two consecutive Hamilton Rating Scale for Depression (HRSD) scores <= 10, and HRSD total score does not change > 3 points or remains < 6 at the last two consecutive treatments. In addition, the investigators will collect data on other treatment parameters such as seizure duration, electroencephalogram (EEG) morphology as well as hemodynamic changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham tDCS | Sham comparator | Device: sham tDCSSham tDCS sessions will last 20 minutes, but a real stimulus of 2 milliamps (mA) will be applied only during the first minute |
| tDCS | Experimental | Device: transcranial magnetic stimulation20 minute tDCS sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects 18 years of age and above;
- Diagnosis of Major Depression confirmed by Structured Clinical Interview for Diagnostic and Statistical Manual IV (SCID-IV) interview;
- ECT is clinically indicated;
- Patient is competent to provide informed consent;
Key exclusion criteria (16 listed)
- Lifetime DSM-IV diagnosis of schizophrenia, schizoaffective disorder or any other primary psychotic disorder as well as Bipolar Disorder, as defined in the DSM-IV;
- Current diagnosis of delirium or any major or minor neurocognitive disorder;
- Diagnosis of Mental Retardation;
- Limited English proficiency;
- Baseline Mini Mental State Exam (MMSE) score < 21 or a total score falling two standard deviations below the age- and education-adjusted mean, whichever is less;
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 |
|---|---|---|
| transcranial magnetic stimulationtDCS stimulation will involve ten 20 minute stimulations daily, characterized by 2 milliamps (mA) anode over the left dorsolateral prefrontal cortex (DLPFC), with the cathode placed over the right suborbital region. | Device | tDCS |
| sham tDCSsham tDCS | Device | sham tDCS |
Primary outcome
Change in memory function
Time frame: up to three months
Change in memory function will be determined by a factor analysis of all memory tests
1 secondary outcome
Number of ECT treatments needed to achieve remission
Time frame: up to three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
Raphael Braga, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Depressive Disorder, run by Northwell Health 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 16 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 22 May 2019. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in memory function (time frame: up to three months). 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 22 May 2019.