Trial Outcomes & Findings for Deep Brain Stimulation for Major Depressive Disorder (NCT NCT00617162)
NCT ID: NCT00617162
Last Updated: 2024-04-08
Results Overview
The MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen.
TERMINATED
NA
125 participants
Baseline to 6 months
2024-04-08
Participant Flow
The aim of this prospective, multi-centered, double-blind, randomized, controlled 12-month pivotal study is to evaluate the safety and efficacy of the SJM Libra® Deep Brain Stimulation System for patients with major depressive disorder who had failed at least 4 treatments in the current episode. The primary outcome assessment occurred at the 6 month vistit, however all patients were followed for 1 year. A total of 201 patients were to be randomized from up to 20 sites.
The protocol allowed enrollment during the screening period. 125 were enrolled but only 90 continued on to receive DBS implants.
Participant milestones
| Measure |
DBS Active Treatment Group
Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation
|
DBS Control Group
Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
30
|
|
Overall Study
COMPLETED
|
53
|
27
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Deep Brain Stimulation for Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
DBS Active Treatment Group
n=60 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation
|
DBS Control Group
n=30 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.53 years
STANDARD_DEVIATION 9.73 • n=5 Participants
|
48.70 years
STANDARD_DEVIATION 10.56 • n=7 Participants
|
49.62 years
STANDARD_DEVIATION 10.16 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
58 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 participants
n=5 Participants
|
27 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Montgomery and Asberg Depression Rating Scale (MADRS)
|
33.8 units on a scale
STANDARD_DEVIATION 4.48 • n=5 Participants
|
37.3 units on a scale
STANDARD_DEVIATION 3.82 • n=7 Participants
|
35.5 units on a scale
STANDARD_DEVIATION 4.15 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsThe MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen.
Outcome measures
| Measure |
DBS Active Treatment Group
n=60 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation
|
DBS Control Group
n=30 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
|
|---|---|---|
|
Montgomery and Asberg Depression Rating Scale (MADRS) Score at Baseline and the Average of Months 4, 5, and 6
Mean Baseline
|
33.8 score on a scale
Standard Deviation 4.48
|
37.3 score on a scale
Standard Deviation 3.82
|
|
Montgomery and Asberg Depression Rating Scale (MADRS) Score at Baseline and the Average of Months 4, 5, and 6
Mean of Months 4, 5, 6
|
27.5 score on a scale
Standard Deviation 9.73
|
29.4 score on a scale
Standard Deviation 9.52
|
SECONDARY outcome
Timeframe: Baseline to 1 yearThe MADRS is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60. The lower a score the less symptom severity is seen.
Outcome measures
| Measure |
DBS Active Treatment Group
n=60 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation
|
DBS Control Group
n=30 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
|
|---|---|---|
|
Baseline MADRS to MADRS at 1 Year
Baseline MADRS
|
33.8 score on a scale
Standard Deviation 4.48
|
37.3 score on a scale
Standard Deviation 3.82
|
|
Baseline MADRS to MADRS at 1 Year
Mean MADRS at 12 months
|
23.2 score on a scale
Standard Deviation 12.15
|
26.7 score on a scale
Standard Deviation 12.06
|
SECONDARY outcome
Timeframe: 6 months-1 yearOutcome measures
| Measure |
DBS Active Treatment Group
n=60 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation
|
DBS Control Group
n=30 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
|
|---|---|---|
|
Number of Participants With Adverse Events (i.e., Hospitalization Due to Worsening Depression, Suicidal Ideation or Behavior, Medical Treatment, and Device Related Events) That Occur Over Study Duration
0 adverse events
|
35 Participants
|
12 Participants
|
|
Number of Participants With Adverse Events (i.e., Hospitalization Due to Worsening Depression, Suicidal Ideation or Behavior, Medical Treatment, and Device Related Events) That Occur Over Study Duration
1 adverse event
|
13 Participants
|
12 Participants
|
|
Number of Participants With Adverse Events (i.e., Hospitalization Due to Worsening Depression, Suicidal Ideation or Behavior, Medical Treatment, and Device Related Events) That Occur Over Study Duration
2 adverse events
|
6 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (i.e., Hospitalization Due to Worsening Depression, Suicidal Ideation or Behavior, Medical Treatment, and Device Related Events) That Occur Over Study Duration
3 adverse events
|
3 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (i.e., Hospitalization Due to Worsening Depression, Suicidal Ideation or Behavior, Medical Treatment, and Device Related Events) That Occur Over Study Duration
4 adverse events
|
1 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events (i.e., Hospitalization Due to Worsening Depression, Suicidal Ideation or Behavior, Medical Treatment, and Device Related Events) That Occur Over Study Duration
5 adverse events
|
2 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (i.e., Hospitalization Due to Worsening Depression, Suicidal Ideation or Behavior, Medical Treatment, and Device Related Events) That Occur Over Study Duration
7 adverse events
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearThe Global Assessment Scale (GAF) is a hypothetical continuum of mental health illness that looks at psychological, social, and occupational functioning. It measures how much a person's symptoms affect their day to-day life on a scale of 0 to 100. A score of 100-91 indicates no symptoms, 90-81 indicates absent minimal symptoms, 80-71 indicates symptoms that are transient and reactions expectable to psychosocial stressors, 70-61 indicates mild symptoms, 60-51 indicates moderate symptoms, 50-41 indicates serious symptoms, 40-31 indicates some impairment in reality testing or communication OR major impairment in several areas, 30-21 indicates delusions or hallucinations, 20-11 indicates danger of hurting self or others OR occasionally fails to maintain personal hygiene, 10-1 indicates persistent danger of severely hurting self or others OR persistent inability to maintain minimal personal hygiene OR serious suicidal act with clear expectation of death and 0 indicates inadequate data.
Outcome measures
| Measure |
DBS Active Treatment Group
n=60 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation
|
DBS Control Group
n=30 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
|
|---|---|---|
|
Global Assessment Scale (GAF) Score at Baseline and 1 Year
Baseline GAF
|
42.0 score on a scale
Standard Deviation 4.27
|
40.6 score on a scale
Standard Deviation 4.73
|
|
Global Assessment Scale (GAF) Score at Baseline and 1 Year
Month 12 GAF
|
54.2 score on a scale
Standard Deviation 15.99
|
53.7 score on a scale
Standard Deviation 13.34
|
SECONDARY outcome
Timeframe: 6 monthsThe Hamilton Rating Scale for Depression - 17 item (HDRS-17) ranging from 0-52 used to assess potential changes in the severity of depressive symptoms (Hamilton 1960; Hamilton 1967). It is used to evaluate depressed mood, vegetative and cognitive symptoms of depression, and co-morbid anxiety symptoms. Scoring is based on the 17-itemscale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the17-point scale.
Outcome measures
| Measure |
DBS Active Treatment Group
n=56 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation
|
DBS Control Group
n=29 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
|
|---|---|---|
|
Hamilton Rating Scale for Depression - 17 Item (HRSD-17) Score at Baseline and 6 Months
HDRS-17 Month 6
|
17.5 units on a scale
Standard Deviation 7.57
|
19.0 units on a scale
Standard Deviation 7.94
|
|
Hamilton Rating Scale for Depression - 17 Item (HRSD-17) Score at Baseline and 6 Months
Baseline HDRS-17
|
20.3 units on a scale
Standard Deviation 3.78
|
22.6 units on a scale
Standard Deviation 4.44
|
SECONDARY outcome
Timeframe: 1 yearThe Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report instrument designed to measure the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. There are 16 areas of functioning, each scored from 1 (very poor) to 5 (very good). The range of scores is 16-80, with lower scores representing lower functioning and satisfaction.
Outcome measures
| Measure |
DBS Active Treatment Group
n=58 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation
|
DBS Control Group
n=28 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
|
|---|---|---|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score From Baseline to 1 Year
Baseline Q-LES-Q
|
33.5 score on a scale
Standard Deviation 6.08
|
28.5 score on a scale
Standard Deviation 5.87
|
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score From Baseline to 1 Year
12 Month Score Q-LES-Q
|
40.1 score on a scale
Standard Deviation 10.72
|
36.8 score on a scale
Standard Deviation 11.35
|
SECONDARY outcome
Timeframe: 1 yearThe construction of the Inventory of Depressive Symptomology (IDS-C30) was intended to remedy deficits in the Hamilton Scale for Depression (HRSD-17) and Montgomery and Asberg (MADRS) depression rating scales by, among others, including all nine symptom domains needed to diagnose a DSM-IV major depressive episode in order to assess symptom remission, improve ability to detect milder levels of symptoms than the HRSD-17, and provide unconfined and more equivalent weighting among items. There are two versions of the IDS with identical items: a clinician rating (IDS-C30) and a self-report (IDS-SR30). Each of the 30 items is rated from 0 to 3, with increasing severity represented by a higher rating. (Rush et al. 1996). When complete, the IDS-C30 and IDS-SR30 are scored by summing responses to 28 of the 30 items to obtain a total score ranging from 0 to 84. Either appetite increase or decrease, but not both, are used to calculate the total score.
Outcome measures
| Measure |
DBS Active Treatment Group
n=60 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation
|
DBS Control Group
n=30 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
|
|---|---|---|
|
Inventory of Depressive Symptomology (IDS-C30) Score From Baseline to 1 Year
Baseline IDS
|
37.0 score on a scale
Standard Deviation 7.42
|
41.1 score on a scale
Standard Deviation 38.24
|
|
Inventory of Depressive Symptomology (IDS-C30) Score From Baseline to 1 Year
Month 12 IDS
|
26.5 score on a scale
Standard Deviation 13.87
|
31.2 score on a scale
Standard Deviation 14.29
|
SECONDARY outcome
Timeframe: 1 yearThe Quick Inventory of Depressive Symptomatology Self Report (QIDS- SR) is a 16-question shortened self-test, derived from the 30-item IDS. Questions in the QIDS - SR-116 correlate with the nine DSM-IV symptom criterion domains, including: Sleep disturbance (initial, middle, and late insomnia or hypersomnia) (Q 1 - 4), Sad mood (Q 5), Decrease/increase in appetite/weight (Q 6 - 9), Concentration (Q 10), Self-criticism (Q 11), Suicidal ideation (Q 12), Interest (Q 13), Energy/fatigue (Q 14), Psychomotor agitation/retardation (Q 15 - 16). The severity of depression can be judged based on the total score ranging from 1-27. A score of 1-5 indicates No depression, 6-10 indicates Mild depression,11-15 indicates Moderate depression, 16-20 indicates Severe depression and 21-27 indicates Very severe depression.
Outcome measures
| Measure |
DBS Active Treatment Group
n=60 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation
|
DBS Control Group
n=30 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
|
|---|---|---|
|
Quick Inventory of Depressive Symptomatology (QIDS-SR) Scores From Baseline to 1 Year
Baseline QIDS-SR
|
17.4 score on a scale
Standard Deviation 3.28
|
19.5 score on a scale
Standard Deviation 2.70
|
|
Quick Inventory of Depressive Symptomatology (QIDS-SR) Scores From Baseline to 1 Year
Month 12 QIDS-SR
|
12.8 score on a scale
Standard Deviation 6.91
|
14.1 score on a scale
Standard Deviation 6.01
|
SECONDARY outcome
Timeframe: 1 yearThe WSAS is a modification of a scale introduced by Hafner and Marks (1976), consisting of 0-8 point ratings of the extent to which symptoms interfere with five areas of daily functioning: work, home management, private leisure, social leisure, and family relationships. It is a well-validated, widely used self-report measure. Additional time points include weeks 4, 8, 12, 16, and 40. A total score calculated as a sum of all items (possible range 0-40) was used in the analyses with higher scores indicating more impairment.
Outcome measures
| Measure |
DBS Active Treatment Group
n=60 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation
|
DBS Control Group
n=30 Participants
Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
|
|---|---|---|
|
Work and Social Adjustment Scale (WSAS) Score From Baseline to 1 Year
Baseline WSAS
|
32.9 score on a scale
Standard Deviation 4.66
|
35.2 score on a scale
Standard Deviation 3.06
|
|
Work and Social Adjustment Scale (WSAS) Score From Baseline to 1 Year
12 month WSAS
|
25.5 score on a scale
Standard Deviation 11.46
|
29.6 score on a scale
Standard Deviation 9.45
|
Adverse Events
DBS Active Treatment Group
DBS Control Group
Serious adverse events
| Measure |
DBS Active Treatment Group
n=60 participants at risk
Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation
|
DBS Control Group
n=30 participants at risk
Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
|
|---|---|---|
|
Surgical and medical procedures
Bariatric weight loss surgery
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
Psychiatric disorders
Suicidal Ideation
|
3.3%
2/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Elective admission to IP unit to alleviate burden on primary carer
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Patient re-admitted on an elective basis to IP unit
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
Infections and infestations
Infection
|
8.3%
5/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
Surgical and medical procedures
Post-operative discomfort
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Seizure or convulsion
|
1.7%
1/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
Psychiatric disorders
Suicide or suicide attempt
|
3.3%
2/60 • 1 year
|
6.7%
2/30 • 1 year
|
|
Psychiatric disorders
Increase in depressive symptoms
|
16.7%
10/60 • 1 year
|
6.7%
2/30 • 1 year
|
|
General disorders
Hearing and visual disturbance
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
Psychiatric disorders
Anxiety
|
3.3%
2/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
Infections and infestations
General erosion
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Headache
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
Other adverse events
| Measure |
DBS Active Treatment Group
n=60 participants at risk
Deep Brain Stimulation, Libra Deep Brain Stimulation System: DBS Active Treatment Group - implanted with investigational device and activated for stimulation
|
DBS Control Group
n=30 participants at risk
Deep Brain Stimulation, Libra Deep Brain Stimulation System: implanted with investigational device, but will not receive active stimulation for the first 6 months of the study
|
|---|---|---|
|
General disorders
Headache
|
30.0%
18/60 • 1 year
|
33.3%
10/30 • 1 year
|
|
General disorders
Middle back pain
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Generalized body pain
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Hyperphagia
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Feeling hot constant
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Feeling cold constant
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Mild worsening of pre-existing tremor
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Jaw pain
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Cutting self
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Suicidal ideation
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Peripheral neuropathy
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Nocturia with urinary frequency
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Dyspepsia
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Flu syndrome
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Leg cramps and soreness on legs
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Motor incoordination left side
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Fractured arm
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Feeling of surgical pressure on IPG site
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Mild tremor
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Oral Thrush
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Churning feeling in the head
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Irritability
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Ridge right side of scalp with twinges of pain
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Burned self left deltoid area
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Increased irritability
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Chest pressure
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Occasional, very mild tremor
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Back pain from carrying heavy load of water
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Patient claims she can "feel the wires in brain"
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Chest pain
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Unilateral eye swelling
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Pustule on suture line
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Hypercholesterolaemia
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Reports of increased cravings for chocolate and biscuits
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Complaining of aches and pains and cramps in hands, arms, and feet
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
Infections and infestations
Infection
|
3.3%
2/60 • 1 year
|
10.0%
3/30 • 1 year
|
|
General disorders
Post operative discomfort
|
8.3%
5/60 • 1 year
|
6.7%
2/30 • 1 year
|
|
General disorders
Cerebrospinal fluid leakage
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Post-operative pain
|
10.0%
6/60 • 1 year
|
20.0%
6/30 • 1 year
|
|
General disorders
Subcutaneous hemorrhage or seroma
|
1.7%
1/60 • 1 year
|
6.7%
2/30 • 1 year
|
|
General disorders
Aphasia
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Nausea and/or vomiting
|
6.7%
4/60 • 1 year
|
13.3%
4/30 • 1 year
|
|
General disorders
Sleep disturbance
|
6.7%
4/60 • 1 year
|
20.0%
6/30 • 1 year
|
|
General disorders
Pulling sensation along extension site
|
10.0%
6/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Persistent pain or redness at the IPG site or surgery site/extension
|
1.7%
1/60 • 1 year
|
23.3%
7/30 • 1 year
|
|
General disorders
Cerebrospinal fluid abnormality
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Hearing and visual disturbance
|
15.0%
9/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Disequilibrium
|
6.7%
4/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Increase in depressive symptoms
|
6.7%
4/60 • 1 year
|
13.3%
4/30 • 1 year
|
|
General disorders
Anxiety
|
10.0%
6/60 • 1 year
|
23.3%
7/30 • 1 year
|
|
General disorders
Eye disorder
|
3.3%
2/60 • 1 year
|
6.7%
2/30 • 1 year
|
|
General disorders
Neuralgia
|
8.3%
5/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Drowsiness
|
5.0%
3/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Skin disorder
|
3.3%
2/60 • 1 year
|
10.0%
3/30 • 1 year
|
|
General disorders
General erosion or local skin erosion over the IPG, burr hold cap, and/or extension
|
15.0%
9/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Paresthesia
|
3.3%
2/60 • 1 year
|
20.0%
6/30 • 1 year
|
|
Psychiatric disorders
Hypomania
|
0.00%
0/60 • 1 year
|
6.7%
2/30 • 1 year
|
|
General disorders
Pneumonia
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
Psychiatric disorders
Suicide or suicide attempt
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Sweating
|
3.3%
2/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Diarrhea
|
3.3%
2/60 • 1 year
|
6.7%
2/30 • 1 year
|
|
General disorders
Cognitive impairment
|
3.3%
2/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Rapid heart rate
|
0.00%
0/60 • 1 year
|
6.7%
2/30 • 1 year
|
|
General disorders
Increase in drug side effects
|
3.3%
2/60 • 1 year
|
6.7%
2/30 • 1 year
|
|
General disorders
Myoclonus
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Syncope
|
0.00%
0/60 • 1 year
|
3.3%
1/30 • 1 year
|
|
General disorders
Asthenia, hemiplegia, or hemiparesis
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
Renal and urinary disorders
Urinary incontinence
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
|
General disorders
Attention deficit
|
1.7%
1/60 • 1 year
|
0.00%
0/30 • 1 year
|
Additional Information
Lyndahl Himes, Sr. Clinical Research Scientist
Abbott
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place