Trial Outcomes & Findings for Epidural Cortical Stimulation for Depression (NCT NCT00565617)

Results Overview

Hamilton Depression Rating Scale (HDRS) is a standard, validated depression rating scale. It is a 24 item scale, but the primary score is based on the first 17 answers for a total score for depression. 0-7=Normal 8 - 13 = Mild Depression 14-18 = Moderate Depression 19 - 22 = Severe Depression \> 23 = Very Severe Depression

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

5 participants

Primary outcome timeframe

7 months from baseline

Results posted on

2025-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Epidural Cortical Stimulation Device for Depression Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46. Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Epidural Cortical Stimulation Device for Depression Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46. Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Epidural Cortical Stimulation for Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Epidural Cortical Stimulation for Depression n=5 Participants Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46. Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles. For further description of arm please refer to published paper Ziad Nahas, Berry S. Anderson, Jeff Borckardt, Ashley B. Arana, Mark S. George, Scott T. Reeves, and Istvan Takacs "Bilateral Epidural Prefrontal Cortical Stimulation for Treatment- Resistant Depression" Biological Psychiatry. 2010
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	44.2 years STANDARD_DEVIATION 9.7 • n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Region of Enrollment United States	5 participants n=93 Participants

PRIMARY outcome

Timeframe: 7 months from baseline

Hamilton Depression Rating Scale (HDRS) is a standard, validated depression rating scale. It is a 24 item scale, but the primary score is based on the first 17 answers for a total score for depression. 0-7=Normal 8 - 13 = Mild Depression 14-18 = Moderate Depression 19 - 22 = Severe Depression \> 23 = Very Severe Depression

Outcome measures

Outcome measures
Measure	Epidural Cortical Stimulation for Depression n=5 Participants Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46. Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles.
HDRS-24 Items Pre	28.4 units on a scale Standard Deviation 8
HDRS-24 Items 7 months	13 units on a scale Standard Deviation 11.4

Adverse Events

Epidural Cortical Stimulation for Depression

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Epidural Cortical Stimulation for Depression n=5 participants at risk Epidural cortical stimulation device (medial prefrontal cortex), implanted with leads bilaterally at Brodmanns area 10 and 46. Synergy, Epidural cortical stimulation: Epidural cortical stimulation. Constant voltage device which can apply varying currents, pulsewidths, frequencies, and duty cycles.
Infections and infestations Infection	20.0% 1/5
Psychiatric disorders Hospitalizations	100.0% 5/5

Other adverse events

Adverse event data not reported

Additional Information

Gregory Sahlem

Medical University of South Carolina

Phone: 843-792-5716

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place