Trial Outcomes & Findings for European Deep Brain Stimulation (DBS) Depression Study (NCT NCT01331330)
NCT ID: NCT01331330
Last Updated: 2024-11-14
Results Overview
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item scale that measures depressive symptom severity. Scores range from 9 to 60, with a higher score indicating more severe depression.
COMPLETED
NA
9 participants
4, 7, 10 and 13 months
2024-11-14
Participant Flow
Participant milestones
| Measure |
Group 1 : High Frequency Group
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
European Deep Brain Stimulation (DBS) Depression Study
Baseline characteristics by cohort
| Measure |
Group 1 : High Frequency Group
n=5 Participants
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
n=4 Participants
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43 years
n=5 Participants
|
51 years
n=7 Participants
|
46 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4, 7, 10 and 13 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item scale that measures depressive symptom severity. Scores range from 9 to 60, with a higher score indicating more severe depression.
Outcome measures
| Measure |
Group 1 : High Frequency Group
n=5 Participants
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
n=4 Participants
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
|
|---|---|---|
|
Mean Percent Change From Baseline in MADRS Score
13 months
|
-37.9 percentage change from baseline
Standard Deviation 25.4
|
-15.9 percentage change from baseline
Standard Deviation 39.1
|
|
Mean Percent Change From Baseline in MADRS Score
4 months
|
-7.7 percentage change from baseline
Standard Deviation 22.8
|
-7.4 percentage change from baseline
Standard Deviation 21.9
|
|
Mean Percent Change From Baseline in MADRS Score
7 months
|
-8.8 percentage change from baseline
Standard Deviation 20.6
|
-6.2 percentage change from baseline
Standard Deviation 10.1
|
|
Mean Percent Change From Baseline in MADRS Score
10 months
|
-42.9 percentage change from baseline
Standard Deviation 28.4
|
-22.7 percentage change from baseline
Standard Deviation 11.4
|
SECONDARY outcome
Timeframe: 4, 7, 10 and 13 monthPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
The Hamilton Depression Rating Scale is a 17-item scale that measures depressive symptom severity. Scores range from 0 to 52, with a higher score indicating more severe depression.
Outcome measures
| Measure |
Group 1 : High Frequency Group
n=5 Participants
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
n=4 Participants
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
|
|---|---|---|
|
Mean Percent Change From Baseline in Hamilton Rating Scale for Depression (HDRS) Score
4 months
|
-6.1 percent change from baseline
Standard Deviation 43.7
|
-28.1 percent change from baseline
Standard Deviation 24.3
|
|
Mean Percent Change From Baseline in Hamilton Rating Scale for Depression (HDRS) Score
7 months
|
-3.0 percent change from baseline
Standard Deviation 38.7
|
-12.9 percent change from baseline
Standard Deviation 15.6
|
|
Mean Percent Change From Baseline in Hamilton Rating Scale for Depression (HDRS) Score
10 months
|
-46.8 percent change from baseline
Standard Deviation 38.4
|
-16.5 percent change from baseline
Standard Deviation 3.1
|
|
Mean Percent Change From Baseline in Hamilton Rating Scale for Depression (HDRS) Score
13 months
|
-34.5 percent change from baseline
Standard Deviation 35.5
|
-21.5 percent change from baseline
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: 4, 7, 10 and 13 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
Outcome measures
| Measure |
Group 1 : High Frequency Group
n=5 Participants
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
n=4 Participants
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
|
|---|---|---|
|
Responder Rate (40% Reduction in MADRS)
4 months
|
0 Participants
|
0 Participants
|
|
Responder Rate (40% Reduction in MADRS)
7 months
|
0 Participants
|
0 Participants
|
|
Responder Rate (40% Reduction in MADRS)
10 months
|
3 Participants
|
0 Participants
|
|
Responder Rate (40% Reduction in MADRS)
13 months
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 4, 7, 10 and 13 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
Developed by M. Hamilton, this widely-used interview scale measures the severity of a patient's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Outcome measures
| Measure |
Group 1 : High Frequency Group
n=5 Participants
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
n=4 Participants
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
|
|---|---|---|
|
Mean Percent Change From Baseline in Hamilton Anxiety Rating Scale (HAMA-A) Score
4 months
|
-8.3 percentage change from baseline
Standard Deviation 41.0
|
-9.5 percentage change from baseline
Standard Deviation 50.7
|
|
Mean Percent Change From Baseline in Hamilton Anxiety Rating Scale (HAMA-A) Score
7 months
|
-5.6 percentage change from baseline
Standard Deviation 48.0
|
-5.9 percentage change from baseline
Standard Deviation 31.6
|
|
Mean Percent Change From Baseline in Hamilton Anxiety Rating Scale (HAMA-A) Score
10 months
|
-26.2 percentage change from baseline
Standard Deviation 48.9
|
-21.9 percentage change from baseline
Standard Deviation 6.3
|
|
Mean Percent Change From Baseline in Hamilton Anxiety Rating Scale (HAMA-A) Score
13 months
|
-18.8 percentage change from baseline
Standard Deviation 46.1
|
25.1 percentage change from baseline
Standard Deviation 62.8
|
SECONDARY outcome
Timeframe: 4, 7, 10 and 13 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
The 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 |
Group 1 : High Frequency Group
n=5 Participants
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
n=4 Participants
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
|
|---|---|---|
|
Mean Percent Change From Baseline in GAF Score
4 months
|
17.2 percentage change from baseline
Standard Deviation 26.4
|
11.1 percentage change from baseline
Standard Deviation 19.2
|
|
Mean Percent Change From Baseline in GAF Score
7 months
|
20.7 percentage change from baseline
Standard Deviation 14.8
|
18.5 percentage change from baseline
Standard Deviation 17.0
|
|
Mean Percent Change From Baseline in GAF Score
10 months
|
34.4 percentage change from baseline
Standard Deviation 30.7
|
18.8 percentage change from baseline
Standard Deviation 26.5
|
|
Mean Percent Change From Baseline in GAF Score
13 months
|
45.2 percentage change from baseline
Standard Deviation 20.9
|
24.3 percentage change from baseline
Standard Deviation 18.7
|
SECONDARY outcome
Timeframe: 4, 7, 10 and 13 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
The Quick Inventory of Depressive Symptomatology Self Report (QIDS- SR) is a 16-question shortened self-test, derived from the 30-item Inventory of Depressive Symptomatology (IDS). Questions in the QIDS - SR-116 correlate with the nine Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (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. 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 |
Group 1 : High Frequency Group
n=5 Participants
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
n=4 Participants
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
|
|---|---|---|
|
Mean Percent Change From Baseline in Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) Score
4 months
|
-0.6 percentage change from baseline
Standard Deviation 17.1
|
-2.8 percentage change from baseline
Standard Deviation 38.2
|
|
Mean Percent Change From Baseline in Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) Score
7 months
|
-10.4 percentage change from baseline
Standard Deviation 24.6
|
-2.3 percentage change from baseline
Standard Deviation 13.4
|
|
Mean Percent Change From Baseline in Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) Score
10 months
|
-41.1 percentage change from baseline
Standard Deviation 47.2
|
-21.0 percentage change from baseline
Standard Deviation 36.4
|
|
Mean Percent Change From Baseline in Quick Inventory of Depressive Symptoms - Self Report (QIDS-SR) Score
13 months
|
-21.3 percentage change from baseline
Standard Deviation 26.7
|
-18.7 percentage change from baseline
Standard Deviation 33.2
|
SECONDARY outcome
Timeframe: 4, 7, 10 and 13 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
The CGI severity of illness scale is a simple validated, single-item, 7-point self-reported categorical scale ranging from 0-7 where 0 indicates not assessed; 1 indicates normal, not at all ill; 2 indicates borderline mentally ill; 3 indicates mildly ill; 4 indicates moderately ill; 5 indicates markedly ill; 6 indicates severely ill; and 7 indicates among the most severely ill patients.
Outcome measures
| Measure |
Group 1 : High Frequency Group
n=5 Participants
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
n=4 Participants
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
|
|---|---|---|
|
Mean Percent Change From Baseline in Clinical Global Impression of Severity and Improvement (CGI) Severity of Illness
13 months
|
-38.6 percentage change from baseline
Standard Deviation 15.5
|
-8.7 percentage change from baseline
Standard Deviation 28.1
|
|
Mean Percent Change From Baseline in Clinical Global Impression of Severity and Improvement (CGI) Severity of Illness
4 months
|
-3.5 percentage change from baseline
Standard Deviation 20.5
|
-6.7 percentage change from baseline
Standard Deviation 14.7
|
|
Mean Percent Change From Baseline in Clinical Global Impression of Severity and Improvement (CGI) Severity of Illness
7 months
|
-12.6 percentage change from baseline
Standard Deviation 13.5
|
-12.7 percentage change from baseline
Standard Deviation 19.2
|
|
Mean Percent Change From Baseline in Clinical Global Impression of Severity and Improvement (CGI) Severity of Illness
10 months
|
-33.6 percentage change from baseline
Standard Deviation 16.6
|
-8.7 percentage change from baseline
Standard Deviation 28.1
|
SECONDARY outcome
Timeframe: 4, 7, 10 and 13 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
The CGI global improvement score ranges from 0-7 where 0 indicates not assessed; 1 indicates very much improved; 2 indicates much improved; 3 indicates minimally improved; 4 indicates no change; 5 indicates minimally worse; 6 indicates much worse; and 7 indicates very much worse.
Outcome measures
| Measure |
Group 1 : High Frequency Group
n=5 Participants
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
n=4 Participants
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
|
|---|---|---|
|
Mean Total CGI for Global Improvement Score
4 months
|
4.0 scores on a scale
Standard Deviation 1.6
|
4.0 scores on a scale
Standard Deviation 1.0
|
|
Mean Total CGI for Global Improvement Score
7 months
|
3.6 scores on a scale
Standard Deviation 0.5
|
3.3 scores on a scale
Standard Deviation 0.6
|
|
Mean Total CGI for Global Improvement Score
10 months
|
2.3 scores on a scale
Standard Deviation 1.3
|
3.0 scores on a scale
Standard Deviation 0.0
|
|
Mean Total CGI for Global Improvement Score
13 months
|
2.0 scores on a scale
Standard Deviation 0.8
|
3.5 scores on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 4, 7, 10 and 13 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
The CGI severity of illness scale is a simple validated, single-item, 7-point self-reported categorical scale ranging from 0-7 where 0 indicates not assessed; 1 indicates normal, not at all ill; 2 indicates borderline mentally ill; 3 indicates mildly ill; 4 indicates moderately ill; 5 indicates markedly ill; 6 indicates severely ill; and 7 indicates among the most severely ill patients.
Outcome measures
| Measure |
Group 1 : High Frequency Group
n=5 Participants
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
n=4 Participants
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
|
|---|---|---|
|
Mean Percent Change From Baseline in Patient Global Impression Index (PGI) Severity of Illness
4 months
|
11.7 percentage change from baseline
Standard Deviation 50.7
|
-4.8 percentage change from baseline
Standard Deviation 21.6
|
|
Mean Percent Change From Baseline in Patient Global Impression Index (PGI) Severity of Illness
7 months
|
12.0 percentage change from baseline
Standard Deviation 49.6
|
20.0 percentage change from baseline
Standard Deviation 20.0
|
|
Mean Percent Change From Baseline in Patient Global Impression Index (PGI) Severity of Illness
10 months
|
-26.1 percentage change from baseline
Standard Deviation 23.7
|
26.2 percentage change from baseline
Standard Deviation 57.2
|
|
Mean Percent Change From Baseline in Patient Global Impression Index (PGI) Severity of Illness
13 months
|
-24.0 percentage change from baseline
Standard Deviation 17
|
26.2 percentage change from baseline
Standard Deviation 57.2
|
SECONDARY outcome
Timeframe: 4, 7, 10 and 13 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis.
The CGI global improvement score ranges from 0-7 where 0 indicates not assessed; 1 indicates very much improved; 2 indicates much improved; 3 indicates minimally improved; 4 indicates no change; 5 indicates minimally worse; 6 indicates much worse; and 7 indicates very much worse.
Outcome measures
| Measure |
Group 1 : High Frequency Group
n=5 Participants
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
n=4 Participants
Group 2 : DBS Low Frequency (LF) Group Device Programming (20 Hz) Implanted with investigational device and activated for stimulation.
|
|---|---|---|
|
Mean Total PGI for Global Improvement Score
4 months
|
4.2 scores on a scale
Standard Deviation 1.8
|
4.3 scores on a scale
Standard Deviation 1.2
|
|
Mean Total PGI for Global Improvement Score
7 months
|
4.0 scores on a scale
Standard Deviation 1.4
|
4.0 scores on a scale
Standard Deviation 0.0
|
|
Mean Total PGI for Global Improvement Score
10 months
|
2.3 scores on a scale
Standard Deviation 1.9
|
4.0 scores on a scale
Standard Deviation 1.4
|
|
Mean Total PGI for Global Improvement Score
13 months
|
2.3 scores on a scale
Standard Deviation 1.0
|
3.0 scores on a scale
Standard Deviation 0.0
|
Adverse Events
Group 1 : High Frequency Group
Group 2 : Low Frequency Group
Serious adverse events
| Measure |
Group 1 : High Frequency Group
n=5 participants at risk
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
n=4 participants at risk
Group 2 : DBS Low Frequency (LF) Group Device Programming (, 20 Hz)) Implanted with investigational device and activated for stimulation.
|
|---|---|---|
|
Psychiatric disorders
Overdose of Diathipin and Valium
|
20.0%
1/5 • Number of events 1
|
0.00%
0/4
|
Other adverse events
| Measure |
Group 1 : High Frequency Group
n=5 participants at risk
Group 1 : DBS High Frequency (HF) Group Device Programming (130 Hz) Implanted with investigational device and activated for stimulation.
|
Group 2 : Low Frequency Group
n=4 participants at risk
Group 2 : DBS Low Frequency (LF) Group Device Programming (, 20 Hz)) Implanted with investigational device and activated for stimulation.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal upset and tremors
|
0.00%
0/5
|
25.0%
1/4
|
|
Gastrointestinal disorders
Abdominal upset, hyperacidity and diarrhea
|
0.00%
0/5
|
25.0%
1/4
|
|
Gastrointestinal disorders
Diarrhea and vomiting
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Dental abscess (lower jaw on the left side)
|
20.0%
1/5
|
0.00%
0/4
|
|
General disorders
Dizziness and losing balance (otitis media)
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Episode of anxiety
|
20.0%
1/5
|
0.00%
0/4
|
|
General disorders
Facial pain
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
First of 2 falls
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Frontal headache on the left side
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Itching at the front hairline
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Itching of the scalp, when the head bandage was on
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Itchy scalp
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Losing balance
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Poor memory to recent events
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Scalp itching under the head bandage
|
20.0%
1/5
|
0.00%
0/4
|
|
General disorders
Second of 2 falls
|
0.00%
0/5
|
25.0%
1/4
|
|
General disorders
Sensation (tingling) in different parts of the face on touching the scalp
|
20.0%
1/5
|
0.00%
0/4
|
|
General disorders
Sore throat, fever, lethargy, drowsiness
|
20.0%
1/5
|
0.00%
0/4
|
|
General disorders
Tightness in the neck
|
0.00%
0/5
|
25.0%
1/4
|
|
Injury, poisoning and procedural complications
Blood oozing (bleeding) from the incision on the left side of the scalp
|
0.00%
0/5
|
25.0%
1/4
|
|
Injury, poisoning and procedural complications
Burning sensation over the chest scar
|
20.0%
1/5
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Itching and pain at the site of the surgical incision in the chest on moving the left arm
|
20.0%
1/5
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Mild headache at the site of the incisions in the scalp
|
0.00%
0/5
|
25.0%
1/4
|
|
Injury, poisoning and procedural complications
Mild pain and tenderness at left upper side of the chest (battery site)
|
0.00%
0/5
|
25.0%
1/4
|
|
Injury, poisoning and procedural complications
Pain (neuralgia) over the left tempromadipular joint and extended to left scalp
|
20.0%
1/5
|
0.00%
0/4
|
|
Injury, poisoning and procedural complications
Pain and tenderness at the site of the chest incision
|
0.00%
0/5
|
25.0%
1/4
|
|
Injury, poisoning and procedural complications
Post operative headache
|
0.00%
0/5
|
25.0%
1/4
|
|
Injury, poisoning and procedural complications
Post surgical headache (mainly in the forehead, throbbing in nature)
|
0.00%
0/5
|
25.0%
1/4
|
|
Injury, poisoning and procedural complications
Redness and mild swelling at the site of the left scalp incision and chest incision
|
0.00%
0/5
|
25.0%
1/4
|
|
Injury, poisoning and procedural complications
Redness and swelling at the site of the chest incision
|
0.00%
0/5
|
25.0%
1/4
|
|
Injury, poisoning and procedural complications
Stabbing pain at the site of the chest surgical incision
|
0.00%
0/5
|
25.0%
1/4
|
|
Injury, poisoning and procedural complications
Tenderness at the left side of the scalp when the patient lies down on that side
|
0.00%
0/5
|
25.0%
1/4
|
|
Injury, poisoning and procedural complications
Throbbing sensation at the site of the right scalp incision
|
0.00%
0/5
|
25.0%
1/4
|
|
Nervous system disorders
Aching pain over the middle 3 fingers and palm of the right hand
|
0.00%
0/5
|
25.0%
1/4
|
|
Product Issues
Vibration at the top left end of the ipg
|
0.00%
0/5
|
25.0%
1/4
|
|
Renal and urinary disorders
Pollakiury
|
20.0%
1/5
|
0.00%
0/4
|
|
Respiratory, thoracic and mediastinal disorders
Esophageal irritation
|
0.00%
0/5
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat (upper respiratory tract infection)
|
0.00%
0/5
|
25.0%
1/4
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
0.00%
0/5
|
25.0%
1/4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place