Trial Outcomes & Findings for Nonconvulsive Electrotherapy: a Proof-of-concept Trial (NCT NCT01065597)

Results Overview

Score range is 0 to 54 points. The higher the score, the more depressed symptoms.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

13 participants

Primary outcome timeframe

Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments

Results posted on

2023-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Nonconvulsive Electrotherapy Open label single arm study of nonconvulsive electrotherapy Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold.
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Nonconvulsive Electrotherapy Open label single arm study of nonconvulsive electrotherapy Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold.
Overall Study Adverse Event	1

Baseline Characteristics

Nonconvulsive Electrotherapy: a Proof-of-concept Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nonconvulsive Electrotherapy n=13 Participants Open label single arm study of nonconvulsive electrotherapy Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41.3 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments

Population: 2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data

Score range is 0 to 54 points. The higher the score, the more depressed symptoms.

Outcome measures

Outcome measures
Measure	Nonconvulsive Electrotherapy n=11 Participants Open label single arm study of nonconvulsive electrotherapy Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold.
Change in Score on the 17-item Hamilton Depression Rating Scale	-11.6 units on a scale Standard Deviation 8.2

SECONDARY outcome

Timeframe: Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments

Population: 2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data

Score range is 0 to 30 points. The higher the score, the better the cognition. So a higher score means less cognitive impairment.

Outcome measures

Outcome measures
Measure	Nonconvulsive Electrotherapy n=11 Participants Open label single arm study of nonconvulsive electrotherapy Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold.
Change in Score on Mini-mental State Exam	0.9 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments

Population: 2 of 13 subjects had seizures during first treatment; therefore, there are no seizure-free data for them that would qualify as nonconvulsive treatment data

The Autobiographical Memory Inventory Short Form (AMI-S ) assesses effects on retrograde memory for autobiographical information including information related to a family member, recent travel, events of last New Year's eve, events of last birthday, employment information, and events of last non-psychiatric illness and its treatment. Subjects responded to specific questions regarding these topics before and after their course of NET treatment. Subjects were scored based on the percent of responses post-NET treatment that correctly matched their responses prior to NET treatment. The score range is 0 to 100%. The higher the percent, the less impaired is the autobiographical memory.

Outcome measures

Outcome measures
Measure	Nonconvulsive Electrotherapy n=11 Participants Open label single arm study of nonconvulsive electrotherapy Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold.
Change in Score on the Autobiographical Memory Inventory Short Form (AMI-S)	97 % correct responses Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments

Population: 2 subjects had a seizure during the first treatment and therefore had no seizure-free (nonconvulsive) data, and 2 subjects declined blood draw

Change in plasma level of BDNF in pg/ml pre and post NET treatment course.

Outcome measures

Outcome measures
Measure	Nonconvulsive Electrotherapy n=9 Participants Open label single arm study of nonconvulsive electrotherapy Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold.
Change in Brain-derived Neurotrophic Factor (BDNF) Blood Level	22 pg/ml Interval -104.0 to 208.0

Adverse Events

Nonconvulsive Electrotherapy

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nonconvulsive Electrotherapy n=13 participants at risk Open label single arm study of nonconvulsive electrotherapy Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold.
Nervous system disorders Induced seizure	23.1% 3/13 • 4 years Subjects each participated for 2-4 weeks over the 4 year total duration of study. Participants were queried for adverse events, defined as an unwelcome change in physical or mental status that required clinical assessment, prior to and following each treatment.
Nervous system disorders Headache	23.1% 3/13 • 4 years Subjects each participated for 2-4 weeks over the 4 year total duration of study. Participants were queried for adverse events, defined as an unwelcome change in physical or mental status that required clinical assessment, prior to and following each treatment.
General disorders Fatigue	23.1% 3/13 • 4 years Subjects each participated for 2-4 weeks over the 4 year total duration of study. Participants were queried for adverse events, defined as an unwelcome change in physical or mental status that required clinical assessment, prior to and following each treatment.
Musculoskeletal and connective tissue disorders Jaw pain	15.4% 2/13 • 4 years Subjects each participated for 2-4 weeks over the 4 year total duration of study. Participants were queried for adverse events, defined as an unwelcome change in physical or mental status that required clinical assessment, prior to and following each treatment.
Cardiac disorders Cardiac arrhythmia	7.7% 1/13 • 4 years Subjects each participated for 2-4 weeks over the 4 year total duration of study. Participants were queried for adverse events, defined as an unwelcome change in physical or mental status that required clinical assessment, prior to and following each treatment.
Psychiatric disorders Anxiety dream	7.7% 1/13 • 4 years Subjects each participated for 2-4 weeks over the 4 year total duration of study. Participants were queried for adverse events, defined as an unwelcome change in physical or mental status that required clinical assessment, prior to and following each treatment.
Nervous system disorders Dizziness	7.7% 1/13 • 4 years Subjects each participated for 2-4 weeks over the 4 year total duration of study. Participants were queried for adverse events, defined as an unwelcome change in physical or mental status that required clinical assessment, prior to and following each treatment.
Respiratory, thoracic and mediastinal disorders Sore throat	7.7% 1/13 • 4 years Subjects each participated for 2-4 weeks over the 4 year total duration of study. Participants were queried for adverse events, defined as an unwelcome change in physical or mental status that required clinical assessment, prior to and following each treatment.

Additional Information

William T. Regenold, MDCM

Department of Psychiatry, University of Maryland School of Medicine

Phone: 410-328-6511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place