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Trial record 3 of 3 for:    bipolar tms baltimore

Nonconvulsive Electrotherapy: a Proof-of-concept Trial

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ClinicalTrials.gov Identifier: NCT01065597
Recruitment Status : Completed
First Posted : February 9, 2010
Results First Posted : August 10, 2015
Last Update Posted : August 28, 2015
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
William T Regenold, University of Maryland

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Depressive Disorder
Bipolar Disorder
Schizoaffective Disorder
Intervention Device: Nonconvulsive electrotherapy
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Nonconvulsive Electrotherapy
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 13
Completed 12
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Nonconvulsive Electrotherapy
Hide Arm/Group Description

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 Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
13
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
41.3  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
7
  53.8%
Male
6
  46.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Change in Score on the 17-item Hamilton Depression Rating Scale
Hide Description Score range is 0 to 54 points. The higher the score, the more depressed symptoms.
Time Frame Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Nonconvulsive Electrotherapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
-11.6  (8.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nonconvulsive Electrotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments This was a paired t-test.
2.Secondary Outcome
Title Change in Score on Mini-mental State Exam
Hide Description Score range is 0 to 30 points. The higher the score, the better the cognition. So a higher score means less cognitive impairment.
Time Frame Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Nonconvulsive Electrotherapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.9  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nonconvulsive Electrotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments This was a paired t-test.
3.Secondary Outcome
Title Change in Score on the Autobiographical Memory Inventory Short Form (AMI-S)
Hide Description 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.
Time Frame Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Nonconvulsive Electrotherapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: % correct responses
97  (2.2)
4.Secondary Outcome
Title Change in Brain-derived Neurotrophic Factor (BDNF) Blood Level
Hide Description Change in plasma level of BDNF in pg/ml pre and post NET treatment course.
Time Frame Baseline and at the end of the NET treatment course 2-4 weeks later, depending on the number of NET treatments
Hide Outcome Measure Data
Hide Analysis Population Description
2 subjects had a seizure during the first treatment and therefore had no seizure-free (nonconvulsive) data, and 2 subjects declined blood draw
Arm/Group Title Nonconvulsive Electrotherapy
Hide Arm/Group Description:

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 Number of Participants Analyzed 9
Median (Full Range)
Unit of Measure: pg/ml
22
(-104 to 208)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nonconvulsive Electrotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 4 years
Adverse Event Reporting Description 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.
 
Arm/Group Title Nonconvulsive Electrotherapy
Hide Arm/Group Description

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.

All-Cause Mortality
Nonconvulsive Electrotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Nonconvulsive Electrotherapy
Affected / at Risk (%)
Total   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Nonconvulsive Electrotherapy
Affected / at Risk (%)
Total   10/13 (76.92%) 
Cardiac disorders   
Cardiac arrhythmia   1/13 (7.69%) 
General disorders   
Fatigue   3/13 (23.08%) 
Musculoskeletal and connective tissue disorders   
Jaw pain   2/13 (15.38%) 
Nervous system disorders   
Induced seizure  [1]  3/13 (23.08%) 
Headache   3/13 (23.08%) 
Dizziness   1/13 (7.69%) 
Psychiatric disorders   
Anxiety dream   1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
Sore throat   1/13 (7.69%) 
Indicates events were collected by systematic assessment
[1]
These 3 subjects had electrically induced seizure despite aim to avoid this by using a lower dose of electricity.
Certain Agreements
Principal Investigators are NOT 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.
Results Point of Contact
Name/Title: William T. Regenold, MDCM
Organization: Department of Psychiatry, University of Maryland School of Medicine
Phone: 410-328-6511
Responsible Party: William T Regenold, University of Maryland
ClinicalTrials.gov Identifier: NCT01065597     History of Changes
Other Study ID Numbers: HP-00040324
First Submitted: February 8, 2010
First Posted: February 9, 2010
Results First Submitted: June 12, 2015
Results First Posted: August 10, 2015
Last Update Posted: August 28, 2015