Trial Outcomes & Findings for Safety Study of Deep Brain Stimulation to Manage Thalamic Pain Syndrome (NCT NCT01072656)
NCT ID: NCT01072656
Last Updated: 2017-06-09
Results Overview
Pain Disability Index (PDI) directly measures disability related to the main components of daily life function and has been validated for thalamic pain syndrome. Range is 0 (no disability) to 10 (worst disability). The components are Family/Home Responsibilities, Recreation, Social Activity, Sexual Behavior, Life-support Activity, Occupation, \& Self-care. This is an average score of the 3 month period for each Active and Sham phase.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Blinded stimulation phase (3 Months)
Results posted on
2017-06-09
Participant Flow
11 participants signed informed consent, 10 participants had surgery, 1 participant dropped the study prior to randomization phase, 9 participants were analyzed.
Participant milestones
| Measure |
Active First
active stimulation programmed to the settings found to be optimal during the titration phase
|
Sham First
sham stimulation - IPG ON, at 0 Volt
|
|---|---|---|
|
First Intervention
STARTED
|
5
|
4
|
|
First Intervention
COMPLETED
|
5
|
4
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
5
|
4
|
|
Second Intervention
COMPLETED
|
5
|
4
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Deep Brain Stimulation to Manage Thalamic Pain Syndrome
Baseline characteristics by cohort
| Measure |
Active First
n=5 Participants
active stimulation programmed to the settings found to be optimal during the titration phase
|
Sham First
n=4 Participants
sham stimulation - IPG ON, at 0 Volt
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
54 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
52 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blinded stimulation phase (3 Months)Pain Disability Index (PDI) directly measures disability related to the main components of daily life function and has been validated for thalamic pain syndrome. Range is 0 (no disability) to 10 (worst disability). The components are Family/Home Responsibilities, Recreation, Social Activity, Sexual Behavior, Life-support Activity, Occupation, \& Self-care. This is an average score of the 3 month period for each Active and Sham phase.
Outcome measures
| Measure |
Active Stimulation
n=9 Participants
Active stimulation and programmed to the settings found to be optimal during the titration process.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
|
Sham Stimulation
n=9 Participants
IPG is set to ON but the voltage is set to 0V.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
|
|---|---|---|
|
Number of Participants With 50% Improvement in Pain Related Disability (as Assessed by the Pain Disability Index)
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 24 months post randomization follow upA 50% improvement in pain related disability (as assessed by the pain disability index) at the end of the open label phase compared to the pre-implantation baseline. The PDI ranges from 0-10 with 0 equaling no disability and 10 equaling worst disability.
Outcome measures
| Measure |
Active Stimulation
n=9 Participants
Active stimulation and programmed to the settings found to be optimal during the titration process.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
|
Sham Stimulation
IPG is set to ON but the voltage is set to 0V.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
|
|---|---|---|
|
Number of Participants Who Had 50% Improvement in PDI
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: End of Open Label Phase (24 months)A positive answer from patients receiving active stimulation at the end of the open label phase of the study to the question: 'would you undergo this procedure again if you were to get the same benefits you experienced?'
Outcome measures
| Measure |
Active Stimulation
n=9 Participants
Active stimulation and programmed to the settings found to be optimal during the titration process.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
|
Sham Stimulation
IPG is set to ON but the voltage is set to 0V.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
|
|---|---|---|
|
Number of Participants Who Would Undergo the Procedure Again.
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and 24 monthsPatients report reduction in the VAS (Visual Analogue Scale Ranging from 0-10, 0 meaning no pain and 10 meaning worst pain imaginable) at the end of the open label phase (24 months post randomization f/u) compared to the pre-implantation baseline.
Outcome measures
| Measure |
Active Stimulation
n=9 Participants
Active stimulation and programmed to the settings found to be optimal during the titration process.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
|
Sham Stimulation
IPG is set to ON but the voltage is set to 0V.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
|
|---|---|---|
|
Number of Patient Who Had >50% Reduction in VAS.
|
2 Participants
|
—
|
Adverse Events
Active Stimulation (Phase V)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Sham Stimulation (Phase V)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase I-IV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active Stimulation (Phase V)
n=9 participants at risk
Active stimulation and programmed to the settings found to be optimal during the titration process.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
|
Sham Stimulation (Phase V)
n=9 participants at risk
IPG is set to ON but the voltage is set to 0V.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
|
Phase I-IV
n=9 participants at risk
Phase I-IV is time frame of patient consent through surgery just prior to beginning Active v Sham Stimulation Phase.
|
|---|---|---|---|
|
Nervous system disorders
FOCAL PARTIAL SEIZURE
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Back surgery
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Nervous system disorders
Complex Partial Seizure
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Right Burr Hole Dehiscence
|
11.1%
1/9
|
0.00%
0/9
|
0.00%
0/9
|
|
Infections and infestations
Infection
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Infections and infestations
Sepsis
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Gastrointestinal disorders
Acute Gastric Ulcer w/out Hemorrhage or Perferation
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Acute Post Hemorrhagic Anemia
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Cellulitis
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Renal and urinary disorders
Kidney Stone Bacteremia
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Cardiac disorders
Pulmonary Embolism
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Abscessed Tooth
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Enterocolitis from C Diff
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Appendectomy
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
Other adverse events
| Measure |
Active Stimulation (Phase V)
n=9 participants at risk
Active stimulation and programmed to the settings found to be optimal during the titration process.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
|
Sham Stimulation (Phase V)
n=9 participants at risk
IPG is set to ON but the voltage is set to 0V.
Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
|
Phase I-IV
n=9 participants at risk
Phase I-IV is time frame of patient consent through surgery just prior to beginning Active v Sham Stimulation Phase.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Weakness
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 2
|
|
Nervous system disorders
Patient Fall
|
11.1%
1/9 • Number of events 2
|
11.1%
1/9 • Number of events 1
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Redness from pulling at scab behind ear at head frame site
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 2
|
|
Psychiatric disorders
Hypomania
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Gastrointestinal disorders
Acid Reflux
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 3
|
|
Psychiatric disorders
Auditory Hallucinations
|
0.00%
0/9
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Scalp Soreness
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Nervous system disorders
Fatigue
|
11.1%
1/9 • Number of events 2
|
0.00%
0/9
|
0.00%
0/9
|
|
Psychiatric disorders
Increased Libido
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Nervous system disorders
Reoccurrence of chronic sciatica
|
22.2%
2/9 • Number of events 2
|
0.00%
0/9
|
0.00%
0/9
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Number of events 2
|
0.00%
0/9
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Symptoms from L5-S1 degerative disc disease
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Renal and urinary disorders
Urinary tract complicatoin
|
0.00%
0/9
|
22.2%
2/9 • Number of events 3
|
0.00%
0/9
|
|
Psychiatric disorders
Increased sleep
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Nervous system disorders
Increased sensitivity at bottom of feet
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Nervous system disorders
Balance difficulty
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Left ankle pain/giving out
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Itchy scalp
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Psychiatric disorders
Attention deficit disorder exacerbation
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Diabetes III-controlled
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Reproductive system and breast disorders
Yeast infection
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Feels like extremities are in vice
|
0.00%
0/9
|
11.1%
1/9 • Number of events 2
|
0.00%
0/9
|
|
Psychiatric disorders
Outdoor temperature increases pain
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Root canal
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Eye disorders
Eye infection
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Right hand pain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Low back pain
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Psychiatric disorders
Worsening intensity of suicide ideation
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Gastrointestinal disorders
Inguinal hernia
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Nervous system disorders
Worsening pain
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Psychiatric disorders
Difficulties concentrating
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Torso extreme tightness
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
When left side laying only, torso sweats
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Nervous system disorders
Walking is more ataxic
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Nervous system disorders
Increased pain with DBS turned off
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Infections and infestations
Infection
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Vascular disorders
ED for BP spike
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Infections and infestations
Influenza
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Nervous system disorders
Edema in right foot
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Nervous system disorders
Carpel tunnel syndrome
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
|
Nervous system disorders
Intermittent leg twitch
|
22.2%
2/9 • Number of events 2
|
0.00%
0/9
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Infection from animal bite
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Vascular disorders
Carotid trickling
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
0.00%
0/9
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/9
|
11.1%
1/9 • Number of events 1
|
0.00%
0/9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place