Trial Outcomes & Findings for Evaluation of the Percutaneous SCS Trial Using the DSSEP Collision Testing (NCT NCT02614079)

Results Overview

Positive collision: 75% or greater decrease in amplitude from the baseline waveform. Centroparietal (CPz)-Popliteal Fossa (Fpz) cortical montage (images) will be used as primary montage to evaluate collision results.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

Day 1

Results posted on

2018-03-15

Participant Flow

Participants were recruited from subjects scheduled to receive the Spinal Cord stimulator (SCS) trial leads at the University of Toledo Medical Center.

6 participants were enrolled.

Participant milestones

Participant milestones
Measure	DSSEP - Dermatomal Somato Sensory Evoked Potentials DSSEP testing after SCS trial lead placement DSSEP: Collision testing after the placement of SCS leads
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	DSSEP - Dermatomal Somato Sensory Evoked Potentials DSSEP testing after SCS trial lead placement DSSEP: Collision testing after the placement of SCS leads
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DSSEP n=6 Participants DSSEP testing after SCS trial lead placement DSSEP: Collision testing after the placement of SCS leads
Age, Categorical <=18 years	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=6 Participants
Age, Categorical >=65 years	0 Participants n=6 Participants
Sex: Female, Male Female	4 Participants n=6 Participants
Sex: Female, Male Male	2 Participants n=6 Participants

PRIMARY outcome

Timeframe: Day 1

Population: 5 participants completed DSSEP testing after placement of SCS Trial leads.

Positive collision: 75% or greater decrease in amplitude from the baseline waveform. Centroparietal (CPz)-Popliteal Fossa (Fpz) cortical montage (images) will be used as primary montage to evaluate collision results.

Outcome measures

Outcome measures
Measure	DSSEP n=5 Participants DSSEP testing after SCS trial lead placement DSSEP: Collision testing after the placement of SCS leads
Number of Participants With Positive Collision	2 Participants

Adverse Events

DSSEP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph Atallah, MD

University of Toledo Medical Center

Phone: 419-383-6699

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place