MSTvsEST: Study Comparing Magnetic Seizure Therapy (MST) to Electroconvulsive Therapy (ECT) for Depression in Older Adults

• Sponsor: New York State Psychiatric Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT01869374
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Actual Duration (Months): 96
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

To evaluate the feasibility, tolerability and efficacy of Magnetic Seizure Therapy (MST) in elderly patients with a major depressive episode, who are randomly assigned to receive an acute course of MST or ECT.

The investigators hypothesize:

1. MST and ECT will have similar antidepressant efficacy

2. MST will have less post-treatment amnesia than ECT as reflected in a primary measures of anterograde and retrograde amnesia following the acute treatment phase.

3. At follow up, MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT.

Condition or Disease	Intervention/Treatment	Phase
Depression; Major Depressive Episode; Bipolar Disorder	Device: MagVenture MagPro MST; Biological: RUL ECT	Phase 1/Phase 2

Detailed Description

The purpose of this study is to compare the clinical efficacy and side effects of Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in older adults currently experiencing a major depressive episode in the context of either unipolar or bipolar depression. ECT is known to be highly effective in treating depression, but it can have some adverse cognitive side effects. MST is a new form of convulsive therapy that is being developed as a means of improving the side effect profile of ECT so that more patients may benefit without suffering significant detrimental effects on cognition.

Both ECT and MST rely on a therapeutic seizure, but they do so in different ways. In ECT, an electrical stimulator is used to pass electrical current between two electrodes placed on the surface of person's head, which causes some electricity to go through the brain and cause a seizure. In MST, a magnetic stimulator is used to create a magnetic field in a targeted area of the brain, which induces a small electrical field in the neurons that causes a seizure. Treatments will be administered three times a week.

In addition to the treatment sessions, this study will involve a number of assessments at different time-points (i.e., baseline prior to treatment, post-treatment, 2 months post-treatment and 6 months post-treatment) that are used to evaluate the person's antidepressant response and the physical and cognitive side effects of treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Electroconvulsive Therapy / Magnetic Seizure TherapyElectroconvulsive Therapy / Magnetic Seizure Therapy
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Outcomes in Geriatric Depression: Magnetic Seizure Therapy
• Actual Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Magnetic Seizure Therapy (MST) MagVenture MagPro MST device	Device: MagVenture MagPro MST; Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.
Active Comparator: RUL ECT Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus	Biological: RUL ECT; RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.; Other Names: Right Unilateral Electroconvulsive Therapy

Outcome Measures

Primary Outcome Measures

1. Hamilton Rating Scale for Depression, 24-Item (HRSD-24) [baseline (pre-treatment) and post-treatment]

   The unabbreviated scale title is "Hamilton Rating Scale for Depression." As its title suggests, this is a clinical measure of major depressive disorder. The minimum score a participant could receive on this measure is 0. The maximum score that a participant could receive is 75. Please see a table written below that associates HRSD-24 values with clinical outcome: 0-7 = no depression 8-16 = mild depression 17-23 = moderate depression 24 and up = severe depression Calculation details: Outcome data corresponds to baseline HRSD-24 score subtracted from post-tx HRSD-24 score. The larger difference, therefore, corresponds to the more effective treatment for this study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 55-90

• Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder

• Willing and capable to provide informed consent

• Convulsive therapy clinically indicated

• Hamilton Rating Scale for Depression (HRSD24)≥ 20

• Mini Mental State Exam (MMSE) ≥ 24

• For outpatients: responsible adult living with the patient

Exclusion Criteria:

• Current unstable or serious medical condition, or any comorbid medical condition that substantially increases the risks of ECT (such as acute myocardial infarction, space occupying brain lesion or other cause of increased intracranial pressure, unstable aneurysm or vascular malformation, poorly controlled diabetes mellitus, carcinoma, renal failure, hepatic failure)

• History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, history of known structural brain lesion

• Presence of devices that may be affected by MST (pacemaker, medication pump, cochlear implant, implanted brain stimulator, or vagus nerve stimulator implanted)

• History of head trauma with loss of consciousness for greater than 5 minutes

• History of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder

• History of substance abuse or dependence in past 3 months

• Failure to respond to an adequate course of ECT in the current depressive episode

• History of ECT in the past 6 months and/or failure to respond to an adequate trial of ECT lifetime

• Presence of intracardiac lines

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York State Psychiatric Institute	New York	New York	United States	10032

Sponsors and Collaborators

• New York State Psychiatric Institute

Investigators

• Principal Investigator: Stefan B Rowny, MD, MFA, NYSPI/Columbia University

Study Documents (Full-Text)

• Informed Consent Form - Jul 28, 2016
• Study Protocol - Jul 11, 2017

More Information

Publications

• McClintock SM, DeWind NK, Husain MM, Rowny SB, Spellman TJ, Terrace H, Lisanby SH. Disruption of component processes of spatial working memory by electroconvulsive shock but not magnetic seizure therapy. Int J Neuropsychopharmacol. 2013 Feb;16(1):177-87. doi: 10.1017/S1461145711001866. Epub 2012 Jan 5.
• Rowny SB, Benzl K, Lisanby SH. Translational development strategy for magnetic seizure therapy. Exp Neurol. 2009 Sep;219(1):27-35. doi: 10.1016/j.expneurol.2009.03.029. Epub 2009 Apr 5. Review.
• Rowny SB, Cycowicz YM, McClintock SM, Truesdale MD, Luber B, Lisanby SH. Differential heart rate response to magnetic seizure therapy (MST) relative to electroconvulsive therapy: a nonhuman primate model. Neuroimage. 2009 Sep;47(3):1086-91. doi: 10.1016/j.neuroimage.2009.05.070. Epub 2009 Jun 2.
• Rowny, S., & Lisanby, S. H. (2008). Brain Stimulation in Psychiatry. In A. Tasman, J. Kay, J. A. Lieberman, M. B. First & M. Maj (Eds.), Psychiatry (3rd ed.) (pp.2354-2371). Chichester, UK: John Wiley & Sons. DOI: 10.1002/9780470515167.ch109
• Rowny, S., & Lisanby, S. H. (2009). Other Brain Stimulation Methods. In B. J. Sadock, V.A. Sadock & P. Ruiz (Eds.) . Kaplan and Sadock's Comprehensive Textbook of Psychiatry (9th ed.) (Pp. 3301-3314). Lippincott Williams & Wilkins. Philadelphia:PA.

• Responsible Party: Stefan Rowny, Assistant Professor of Clinical Psychiatry, New York State Psychiatric Institute
• ClinicalTrials.gov Identifier: NCT01869374
• Other Study ID Numbers: 6427
• First Posted: Jun 5, 2013
• Last Update Posted: Sep 3, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Stefan Rowny, Assistant Professor of Clinical Psychiatry, New York State Psychiatric Institute: Depression; Brain Stimulation; Seizure therapy; Convulsive Therapy
• Additional relevant MeSH terms: Seizures; Depression; Depressive Disorder; Bipolar Disorder

Study Results

Participant Flow

Pre-assignment Detail	Five-day washout from all anti-depressants and mood stabilizers.

Arm/Group Title	Magnetic Seizure Therapy (MST)	RUL ECT
Arm/Group Description	MagVenture MagPro MST device MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.	Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.
Period Title: Overall Study
STARTED	9	9
COMPLETED	9	8
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Magnetic Seizure Therapy (MST)	Right Unilateral ECT (RUL ECT)	Total
Arm/Group Description	MagVenture MagPro MST device MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.	Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.	Total of all reporting groups
Overall Participants	9	9	18
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 55.6%	4 44.4%	9 50%
>=65 years	4 44.4%	5 55.6%	9 50%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	66.3	65.3	65.8
Sex: Female, Male (Count of Participants)
Female	6 66.7%	5 55.6%	11 61.1%
Male	3 33.3%	4 44.4%	7 38.9%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	9 100%	9 100%	18 100%

Outcome Measures

1. Primary Outcome

Title	Hamilton Rating Scale for Depression, 24-Item (HRSD-24)
Description	The unabbreviated scale title is "Hamilton Rating Scale for Depression." As its title suggests, this is a clinical measure of major depressive disorder. The minimum score a participant could receive on this measure is 0. The maximum score that a participant could receive is 75. Please see a table written below that associates HRSD-24 values with clinical outcome: 0-7 = no depression 8-16 = mild depression 17-23 = moderate depression 24 and up = severe depression Calculation details: Outcome data corresponds to baseline HRSD-24 score subtracted from post-tx HRSD-24 score. The larger difference, therefore, corresponds to the more effective treatment for this study.
Time Frame	baseline (pre-treatment) and post-treatment

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Magnetic Seizure Therapy (MST)	RUL ECT
Arm/Group Description	MagVenture MagPro MST device MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.	Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.
Measure Participants	9	9
Mean (Full Range) [units on a scale]	22.625	15.375

Adverse Events

Time Frame	Adverse event data for participants was collected from baseline to post-treatment (between two and three months, depending on the participants' number of treatments).
Adverse Event Reporting Description	This study did not include a design for monitoring or assessing adverse events. We did not consider any of our participants to be at risk of serious adverse events or all-cause mortality. Prior to enrollment in the study, all our participants were evaluated by a physician and anesthesiologist and were medically cleared to receive an acute course of convulsive therapy. Any risk that would have been contraindicated with convulsive therapy was ruled out in advance of participants' pre-tx scan.
Arm/Group Title	Magnetic Seizure Therapy (MST)		RUL ECT
Arm/Group Description	MagVenture MagPro MST device MagVenture MagPro MST: Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.		Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus RUL ECT: RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.
All Cause Mortality
	Magnetic Seizure Therapy (MST)		RUL ECT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)
Serious Adverse Events
	Magnetic Seizure Therapy (MST)		RUL ECT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Magnetic Seizure Therapy (MST)		RUL ECT
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.