Trial Outcomes & Findings for A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes (NCT NCT02384096)

Results Overview

Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

7, 14 days post activation

Results posted on

2020-11-20

Participant Flow

17 subjects were enrolled in the study. 5 were withdrawn prior to randomization: 4 were withdrawn as failing to meet inclusion criteria and 1 at the subject's request prior to randomization. 12 were randomized, but 1 was randomized in error and was withdrawn same day. Statistically relevant conclusions cannot be made from this small sample size.

Participant milestones

Participant milestones
Measure	Conventional Programming, Then Advanced Programming Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive conventional single source programming followed by Precision Spectra SCS System advanced programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming.	Advanced Programming, Then Conventional Programming Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive Precision Spectra SCS System advanced programming followed by conventional single source programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming.
First Intervention (7 Days) STARTED	5	7
First Intervention (7 Days) COMPLETED	4	7
First Intervention (7 Days) NOT COMPLETED	1	0
Second Intervention (7 Days) STARTED	4	7
Second Intervention (7 Days) COMPLETED	4	6
Second Intervention (7 Days) NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Programming, Then Advanced Programming n=5 Participants Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive conventional single source programming followed by Precision Spectra SCS System advanced programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming.	Advanced Programming, Then Conventional Programming n=7 Participants Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive Precision Spectra SCS System advanced programming followed by conventional single source programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	7 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: 7, 14 days post activation

Population: All subjects who completed the day 7 and day 14 post-activation study visits were included. Statistical analysis was not performed as the sample size is too small to draw any statistically relevant conclusions.

Paresthesia Coverage assesses how much of the subject's painful areas are covered by SCS-induced paresthesia. The number of subjects reporting paresthesia coverage ≥50% is reported.

Outcome measures

Outcome measures
Measure	Conventional Programming, Then Advanced Programming n=4 Participants Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive conventional single source programming followed by Precision Spectra SCS System advanced programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming.	Advanced Programming, Then Conventional Programming n=7 Participants Precision Spectra SCS System with CoverEdge Surgical Lead. Subjects were randomized to first receive Precision Spectra SCS System advanced programming followed by conventional single source programming. Conventional single source programming: Precision Spectra SCS System using conventional single source programming. Precision Spectra SCS System advanced programming: Precision Spectra SCS System using advanced programming.
Number of Participants With Paresthesia Coverage ≥50% Advanced Programming	3 Participants	5 Participants
Number of Participants With Paresthesia Coverage ≥50% Conventional Programming	3 Participants	5 Participants

Adverse Events

All Enrolled Subjects

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Enrolled Subjects n=17 participants at risk Rate of device-related adverse events (AEs) and Serious Adverse Events (SAEs) are reported for 17 enrolled subjects from informed consent through completion of study.
Infections and infestations Infection	5.9% 1/17 • Number of events 1 • From informed consent through completion of study (approximately 3 months) Arms/groups are combined instead of reported per intervention because subjects received both programming types (arms) in this crossover study. Additionally, adverse events did not necessarily occur when a subject was receiving one of the two programming types.
Skin and subcutaneous tissue disorders Rash	5.9% 1/17 • Number of events 1 • From informed consent through completion of study (approximately 3 months) Arms/groups are combined instead of reported per intervention because subjects received both programming types (arms) in this crossover study. Additionally, adverse events did not necessarily occur when a subject was receiving one of the two programming types.
Musculoskeletal and connective tissue disorders Mid back muscle cramps	5.9% 1/17 • Number of events 1 • From informed consent through completion of study (approximately 3 months) Arms/groups are combined instead of reported per intervention because subjects received both programming types (arms) in this crossover study. Additionally, adverse events did not necessarily occur when a subject was receiving one of the two programming types.

Additional Information

Director, Clinical Sciences and Scientific Communication

Boston Scientific Neuromodulation

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60