Trial Outcomes & Findings for RestoreSensor Study (NCT NCT01106404)

Last Updated: 2012-08-30

Results Overview

After subjects experienced both AdaptiveStim and manual programming at 16 weeks post-implant, subjects were asked to compare pain relief and convenience when they had AdaptiveStim ON to AdaptiveStim OFF in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no loss of convenience or improved convenience with no loss of pain relief during the AdaptiveStim programming arm relative to the manual programming arm. These subjects were considered successful for the primary objective.

Recruitment status

COMPLETED

Study phase

Target enrollment

79 participants

Primary outcome timeframe

16 weeks post-implant

Results posted on

2012-08-30

Participant Flow

The sponsor activated 10 study centers after the study protocol was approved by FDA in March 2010. The overall recruitment for study subjects lasted less than 5 months, with the first enrollment on April 20, 2010, and last enrollment on September 3, 2010.

Among the 79 subjects enrolled into the study, there were 3 subjects discontinued prior to implantation. The reasons for discontinuations were withdrawal of consent (n = 2) and eligibility criteria not met (n = 1). A total of 76 subjects were implanted and randomized at 4 weeks post implant.

Participant milestones

Participant milestones
Measure	6-week AdaptiveStim Followed by 6-week Manual Programming Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.	6-week Manual Followed by 6-week AdaptiveStim Programming Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
Period I (First 6 Weeks) STARTED	36	40
Period I (First 6 Weeks) COMPLETED	33	38
Period I (First 6 Weeks) NOT COMPLETED	3	2
Period II (Second 6 Weeks) STARTED	33	38
Period II (Second 6 Weeks) COMPLETED	33	38
Period II (Second 6 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	6-week AdaptiveStim Followed by 6-week Manual Programming Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.	6-week Manual Followed by 6-week AdaptiveStim Programming Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
Period I (First 6 Weeks) Adverse Event	2	0
Period I (First 6 Weeks) Physician Decision	1	0
Period I (First 6 Weeks) Lost to Follow-up	0	1
Period I (First 6 Weeks) Lack of Efficacy	0	1

Baseline Characteristics

RestoreSensor Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	6-week AdaptiveStim Followed by 6-week Manual Programming n=36 Participants Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.	6-week Manual Followed by 6-week AdaptiveStim Programming n=40 Participants Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.	Total n=76 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=93 Participants	30 Participants n=4 Participants	61 Participants n=27 Participants
Age, Categorical >=65 years	5 Participants n=93 Participants	10 Participants n=4 Participants	15 Participants n=27 Participants
Age Continuous	52.5 years STANDARD_DEVIATION 13.0 • n=93 Participants	53.1 years STANDARD_DEVIATION 14.1 • n=4 Participants	52.8 years STANDARD_DEVIATION 13.5 • n=27 Participants
Sex: Female, Male Female	18 Participants n=93 Participants	27 Participants n=4 Participants	45 Participants n=27 Participants
Sex: Female, Male Male	18 Participants n=93 Participants	13 Participants n=4 Participants	31 Participants n=27 Participants
Region of Enrollment United States	36 participants n=93 Participants	40 participants n=4 Participants	76 participants n=27 Participants
average Numeric Pain Rating Scale (NPRS)	6.26 units on a scale STANDARD_DEVIATION 1.48 • n=93 Participants	5.88 units on a scale STANDARD_DEVIATION 2.15 • n=4 Participants	6.06 units on a scale STANDARD_DEVIATION 1.86 • n=27 Participants
worst Numeric Pain Rating Scale (NPRS)	7.60 units on a scale STANDARD_DEVIATION 1.15 • n=93 Participants	7.60 units on a scale STANDARD_DEVIATION 1.63 • n=4 Participants	7.60 units on a scale STANDARD_DEVIATION 1.41 • n=27 Participants

PRIMARY outcome

Timeframe: 16 weeks post-implant

Population: The ITT analysis included 74 subjects; 2 randomized subjects, who discontinued early due to infections, were excluded per protocol. The 3 other subjects who discontinued early were included in ITT analysis and imputed as failures for the primary objective. No imputation method was used for 71 subjects included in the completed case analysis.

Outcome measures

Outcome measures
Measure	6-week AdaptiveStim Followed by 6-week Manual Programming n=34 Participants Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.	6-week Manual Followed by 6-week AdaptiveStim Programming n=40 Participants Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.	NPRS at Baseline (Subject With Score at 16 Weeks Post-implant) Included subjects with NPRS scores from both baseline and 16 weeks post-implant	NPRS at 16 Weeks Post-implant Included subjects with NPRS scores from both baseline and 16 weeks post-implant
Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm Intent-to-treat analysis (n = 34, 40)	91.2 percentage of participants	82.5 percentage of participants	—	—
Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm Completed case analysis (n = 33, 38)	93.9 percentage of participants	86.8 percentage of participants	—	—

SECONDARY outcome

Timeframe: 16 weeks post-implant

Population: A total of 71 subjects with completed data were included in this analysis.

The pain relief question was a 5-point Likert scale question comparing pain relief when using AdaptiveStim programming relative to manual programming after subjects finished both programming periods. The choices were much worse pain relief with AdaptiveStim, somewhat worse pain relief with AdaptiveStim, no difference in pain relief, somewhat better pain relief with AdaptiveStim, and much better pain relief with AdaptiveStim. Subjects who had worsening pain relief were defined as subjects who responded "much worse pain relief with AdaptiveStim" or "somewhat worse pain relief with AdaptiveStim".

Outcome measures

Outcome measures
Measure	6-week AdaptiveStim Followed by 6-week Manual Programming n=33 Participants Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.	6-week Manual Followed by 6-week AdaptiveStim Programming n=38 Participants Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.	NPRS at Baseline (Subject With Score at 16 Weeks Post-implant) Included subjects with NPRS scores from both baseline and 16 weeks post-implant	NPRS at 16 Weeks Post-implant Included subjects with NPRS scores from both baseline and 16 weeks post-implant
Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming	0 percentage of participants	5.3 percentage of participants	—	—

SECONDARY outcome

Timeframe: Baseline, 10 weeks and 16 weeks post-implant

Population: Subjects with manual adjustments data from patient programmer were included in the analysis.

The number of individual adjustments, ie, button presses, were recorded automatically in the patient programmer, which was specifically designed for this study. The number of button presses per day for manual patient programmer adjustments during the manual programming arm and the AdaptiveStim programming arm of the study were compared.

Outcome measures

Outcome measures
Measure	6-week AdaptiveStim Followed by 6-week Manual Programming n=69 Participants Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.	6-week Manual Followed by 6-week AdaptiveStim Programming n=69 Participants Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.	NPRS at Baseline (Subject With Score at 16 Weeks Post-implant) Included subjects with NPRS scores from both baseline and 16 weeks post-implant	NPRS at 16 Weeks Post-implant Included subjects with NPRS scores from both baseline and 16 weeks post-implant
Manual Adjustments Presented as Button Presses	20.9 Button presses per day Standard Deviation 41.4	35.7 Button presses per day Standard Deviation 71.8	—	—

SECONDARY outcome

Timeframe: Baseline, 10 weeks and 16 weeks post-implant

Population: 69 of the 76 subjects completed pain diary for both baseline and 10 weeks. 69 of the 76 subjects completed pain diary for both baseline and 16 weeks. Since 2 datasets had 2 different pairs of data due to different subjects who completed the pain diary, baseline NPRS in two analyses varied slightly.

The 11-point (ie, 0-10) numeric rating scale of pain intensity (NPRS) was used to assess the overall pain at baseline and follow-up visits. In the pain diary, subjects were presented a numeric scale with numbers from 0 to 10, with 0 meaning "No pain" and 10 meaning "Pain as bad as you can imagine," accompanied by the instructions "Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours." The subjects were asked to complete a diary for 7 consecutive days before implant, 10 weeks, and 16 weeks post-implant visits.

Outcome measures

Outcome measures
Measure	6-week AdaptiveStim Followed by 6-week Manual Programming n=69 Participants Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.	6-week Manual Followed by 6-week AdaptiveStim Programming n=69 Participants Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.	NPRS at Baseline (Subject With Score at 16 Weeks Post-implant) n=69 Participants Included subjects with NPRS scores from both baseline and 16 weeks post-implant	NPRS at 16 Weeks Post-implant n=69 Participants Included subjects with NPRS scores from both baseline and 16 weeks post-implant
NPRS Scores From Baseline to Follow-up Visits at 10 Weeks and 16 Weeks Post-implant	5.99 units on a scale Standard Deviation 1.82	4.22 units on a scale Standard Deviation 2.05	5.90 units on a scale Standard Deviation 1.81	4.41 units on a scale Standard Deviation 2.18

Adverse Events

Overall Adverse Events

Serious events: 8 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Overall Adverse Events n=76 participants at risk Overall adverse events were reported.
Infections and infestations Gastroenteritis	1.3% 1/76 • Number of events 1 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Infections and infestations Implant site infection	1.3% 1/76 • Number of events 1 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	1.3% 1/76 • Number of events 1 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Psychiatric disorders Suicide attempt	1.3% 1/76 • Number of events 1 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Cardiac disorders Atrial fibrillation	1.3% 1/76 • Number of events 1 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.3% 1/76 • Number of events 1 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Gastrointestinal disorders Gastritis	1.3% 1/76 • Number of events 1 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Injury, poisoning and procedural complications Fall	1.3% 1/76 • Number of events 1 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Injury, poisoning and procedural complications Seroma	1.3% 1/76 • Number of events 1 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Injury, poisoning and procedural complications Wound dehiscence	1.3% 1/76 • Number of events 1 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.

Other adverse events

Other adverse events
Measure	Overall Adverse Events n=76 participants at risk Overall adverse events were reported.
Nervous system disorders Paraesthesia	5.3% 4/76 • Number of events 4 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Skin and subcutaneous tissue disorders Pruritus	6.6% 5/76 • Number of events 5 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Musculoskeletal and connective tissue disorders Back pain	15.8% 12/76 • Number of events 17 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Musculoskeletal and connective tissue disorders Muscle spasms	13.2% 10/76 • Number of events 11 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Musculoskeletal and connective tissue disorders Pain in extremity	6.6% 5/76 • Number of events 5 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Musculoskeletal and connective tissue disorders Arthralgia	5.3% 4/76 • Number of events 4 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
General disorders Pain	11.8% 9/76 • Number of events 10 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
General disorders Undesirable change in stimulation	27.6% 21/76 • Number of events 25 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
General disorders Change in sensation of stimulation	5.3% 4/76 • Number of events 5 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Infections and infestations Nasopharyngitis	9.2% 7/76 • Number of events 7 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Infections and infestations Influenza	5.3% 4/76 • Number of events 4 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Psychiatric disorders Depression	6.6% 5/76 • Number of events 5 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
Psychiatric disorders Insomnia	5.3% 4/76 • Number of events 4 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.
General disorders Implant site irritation	5.3% 4/76 • Number of events 4 • The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.

Additional Information

Mark Sun, Senior Clinical Research Manager

Neuromodulation Emerging Therapy Clinical Research, Medtronic, Inc

Phone: 763-526-8098

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60