Trial Outcomes & Findings for Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity (NCT NCT00399841)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

End of trial (approximately 5 days)

Results posted on

2020-12-19

Participant milestones
Measure	Study Stimulation at T7 followed by T8 or stimulation at T8 followed by T7 during the trial implant period Precision for Spinal Cord Stimulation: During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.	Stimulation at T7 Followed by T8 Stimulation at T7 followed by T8 during the trial implant period Precision for Spinal Cord Stimulation: During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.	Stimulation at T8 Followed by T7 Stimulation at T8 followed by T7 during the trial implant period Precision for Spinal Cord Stimulation: During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.
Overall Study STARTED	13	0	0
Overall Study Permanent Implant	6	0	0
Overall Study 12-week	2	0	0
Overall Study COMPLETED	1	0	0
Overall Study NOT COMPLETED	12	0	0

Withdrawal data not reported

Spinal Cord Stimulation (SCS) for Neuropathic Pain of Back or Lower Extremity

Baseline characteristics by cohort
Measure	Baseline n=13 Participants Enrolled subjects
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

Timeframe: End of trial (approximately 5 days)

Population: The study was terminated and efforts were made to locate data. No study data are available

Outcome data not reported

Serious events: 2 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events
Measure	Study n=13 participants at risk Stimulation will occur at T7 followed by T8 or T8 followed by T7 during the trial implant period Precision for Spinal Cord Stimulation: During Trial Implant Period, stimulation from single lead initially turned on at the T7 or T8 level, then crossover. At time of permanent implant, subject chooses which level they want the stimulator turned on.
General disorders	7.7% 1/13 • Number of events 2 • Adverse events were collected from enrollment through end of study (52 weeks post-activation or withdrawal). Insufficient data collected. The study was terminated and efforts were made to locate data. Number of participants/randomization assignment unknown.
Nervous system disorders Twitching	7.7% 1/13 • Number of events 1 • Adverse events were collected from enrollment through end of study (52 weeks post-activation or withdrawal). Insufficient data collected. The study was terminated and efforts were made to locate data. Number of participants/randomization assignment unknown.

Adverse event data not reported

Boston Scientific

Phone: 6619494350