Trial Outcomes & Findings for Tourette Syndrome Deep Brain Stimulation (NCT NCT02056873)
NCT ID: NCT02056873
Last Updated: 2024-09-05
Results Overview
The Yale Global Tic Severity Scale (YGTSS) is a 10-item semi-structured clinician-rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms. The items pertaining to the tic ratings are scored on two subscales: motor tics and phonic tics. Behaviors are rated on a 6-point scale. The total scale has been used in this study and has a range of 0-50. A higher score indicates a higher severity of symptoms. Patients reach the outcome measure with a 40% reduction of YGTSS at month 6 post-op compared to baseline (i.e., 40% improvement in their tic severity scale).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Baseline to 6 months post-surgery
Results posted on
2024-09-05
Participant Flow
Patient recruitment occurred from 3/20/14 to 3/16/20. Some participants were referrals from other centers and some were from the UF Health Neurology clinic.
Participant milestones
| Measure |
First Period: Continuous DBS; Second Period: Switch to Responsive DBS in Qualified Patients
The surgical intervention requires implantation of a DBS system: one CM thalamic leads per hemisphere, one Electrocorticography (ECOG) strip per hemisphere, and two neurostimulators implanted in the chest. The strip provides an interface for brain activity to be monitored.
The system includes a programmer with a telemetry interface and a patient remote to check battery and device status. The programmer is used to set up the device, i.e., stimulation and recording, and retrieve data for subsequent review.
First Period: The system will be set to provide continuous deep brain stimulation (CDBS) for the 6 months postsurgery. Subjects will be evaluated monthly as part of normal clinical care for DBS.
Second Period: At 6 months, the investigators will determine whether a subject is a candidate for responsive brain stimulation (RBS). A neuromarker that detects tics significantly must be identified for a subject to receive the second intervention. Qualifying subjects will have the option to change their settings to participate in the RBS stimulation intervention. Subjects who do not qualify or do not participate will continue to receive this intervention for the duration of the study. Subjects will been seen every 6 months for evaluation as part of normal clinical care for DBS.
|
|---|---|
|
Continuous DBS
STARTED
|
10
|
|
Continuous DBS
Qualify for Second Intervention at the End of First Intervention
|
10
|
|
Continuous DBS
COMPLETED
|
10
|
|
Continuous DBS
NOT COMPLETED
|
0
|
|
Responsive DBS
STARTED
|
8
|
|
Responsive DBS
COMPLETED
|
5
|
|
Responsive DBS
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
First Period: Continuous DBS; Second Period: Switch to Responsive DBS in Qualified Patients
The surgical intervention requires implantation of a DBS system: one CM thalamic leads per hemisphere, one Electrocorticography (ECOG) strip per hemisphere, and two neurostimulators implanted in the chest. The strip provides an interface for brain activity to be monitored.
The system includes a programmer with a telemetry interface and a patient remote to check battery and device status. The programmer is used to set up the device, i.e., stimulation and recording, and retrieve data for subsequent review.
First Period: The system will be set to provide continuous deep brain stimulation (CDBS) for the 6 months postsurgery. Subjects will be evaluated monthly as part of normal clinical care for DBS.
Second Period: At 6 months, the investigators will determine whether a subject is a candidate for responsive brain stimulation (RBS). A neuromarker that detects tics significantly must be identified for a subject to receive the second intervention. Qualifying subjects will have the option to change their settings to participate in the RBS stimulation intervention. Subjects who do not qualify or do not participate will continue to receive this intervention for the duration of the study. Subjects will been seen every 6 months for evaluation as part of normal clinical care for DBS.
|
|---|---|
|
Responsive DBS
CDBS parameters of 3 subjects
|
3
|
Baseline Characteristics
Tourette Syndrome Deep Brain Stimulation
Baseline characteristics by cohort
| Measure |
Deep Brain Stimulation (DBS)
n=10 Participants
The surgical intervention requires implantation of a DBS system: one CM thalamic leads per hemisphere, one Electrocorticography (ECOG) strip per hemisphere, and two neurostimulators implanted in the chest. The strip provides an interface for brain activity to be monitored.
The system includes a programmer with a telemetry interface, and a patient remote to check battery and device status. The programmer is used to set up the device, i.e., stimulation and recording, and retrieve data for subsequent review.
The system will be set to provide continuous stimulation for the 6 months postsurgery. Subjects will be seen monthly for evaluation as a part of normal clinical care for DBS. At 6 months, the investigators will determine whether a subject is a candidate for responsive brain stimulation (RBS). Qualifying subjects will have the option to have their settings changed in order to participate in the RBS stimulation intervention. Subjects who do not qualify or do not participate will continue to receive this intervention for the duration of the study. Subjects will been seen every 6 months for evaluation as part of normal clinical care for DBS.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
Yale Global Tic Severity Scale (YGTSS)
|
39 units on the YGTSS scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 months post-surgeryThe Yale Global Tic Severity Scale (YGTSS) is a 10-item semi-structured clinician-rating instrument that provides an evaluation of the number, frequency, intensity, complexity, and interference of motor and phonic symptoms. The items pertaining to the tic ratings are scored on two subscales: motor tics and phonic tics. Behaviors are rated on a 6-point scale. The total scale has been used in this study and has a range of 0-50. A higher score indicates a higher severity of symptoms. Patients reach the outcome measure with a 40% reduction of YGTSS at month 6 post-op compared to baseline (i.e., 40% improvement in their tic severity scale).
Outcome measures
| Measure |
Deep Brain Stimulation (DBS)
n=10 Participants
The surgical intervention requires implantation of a DBS system: one CM thalamic leads per hemisphere, one Electrocorticography (ECOG) strip per hemisphere, and two neurostimulators implanted in the chest. The strip provides an interface for brain activity to be monitored.
The system includes a programmer with a telemetry interface, and a patient remote to check battery and device status. The programmer is used to set up the device, i.e., stimulation and recording, and retrieve data for subsequent review.
The system will be set to provide continuous stimulation for the 6 months postsurgery. Subjects will be seen monthly for evaluation as a part of normal clinical care for DBS. At 6 months, the investigators will determine whether a subject is a candidate for responsive brain stimulation (RBS). Qualifying subjects will have the option to have their settings changed in order to participate in the RBS stimulation intervention. Subjects who do not qualify or do not participate will continue to receive this intervention for the duration of the study. Subjects will been seen every 6 months for evaluation as part of normal clinical care for DBS.
|
|---|---|
|
Number of Participants With a 40% Reduction in Total Tics on the Yale Global Tic Severity Scale (YGTSS) With CDBS (Period 1)
|
4 Participants
|
Adverse Events
Continuous Deep Brain Stimulation (DBS)
Serious events: 4 serious events
Other events: 10 other events
Deaths: 0 deaths
Responsive Brain Stimulation (RBS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Continuous Deep Brain Stimulation (DBS)
n=10 participants at risk
Subjects' DBS surgical intervention requires implantation of two bilateral DBS system: a CM thalamic lead,an ECOG strip leads, one neurostimulator implanted in the chest per hemisphere.
Neurostimulator and leads system includes a programmer with a telemetry interface, and a patient remote control to check device status. The programmer is used to set up the stimulation and signal recording to retrieve data for subsequent review.
The DBS system will provide continuous stimulation for the 6 months following surgery. Subjects will be seen monthly for evaluation as a part of normal clinical care for DBS. At 6 months, the investigators will determine whether the subject is a candidate for responsive brain stimulation (RBS). Qualifying subjects will have the option to have their settings changed in order to participate in the RBS stimulation intervention. Subjects who do not qualify or do not participate will continue to receive this intervention for the duration of the study.
Six months post-surgery, the DBS system will be set to provide responsive stimulation for the duration of the study. Subjects will be seen every 6 months for evaluation as a part of normal clinical care for DBS.
Data gathered from the subject during the first 6 months will be used to determine if this intervention is applicable for each individual subject. Subjects who do not qualify will continue to receive the other study intervention.
|
Responsive Brain Stimulation (RBS)
n=5 participants at risk
At 6 months, the investigators will determine whether the subject is a candidate for responsive brain stimulation (RBS). Qualifying subjects will have the option to have their settings changed in order to participate in the RBS stimulation intervention. Subjects who do not qualify or do not participate will continue to receive this intervention for the duration of the study.
|
|---|---|---|
|
Renal and urinary disorders
renal and urinary disorder, other
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
esophageal ulcers
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
rectal hemorrhage
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
rectal pain
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
gastric ulcer
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Reproductive system and breast disorders
pelvic pain
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Psychiatric disorders
psychiatric disorders - other, mood disorder
|
10.0%
1/10 • Number of events 2 • 3 years
|
0.00%
0/5 • 3 years
|
|
Injury, poisoning and procedural complications
injury, poisoning and procedural complications, other - concussion
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Psychiatric disorders
psychosis
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Infections and infestations
device related infection
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
Other adverse events
| Measure |
Continuous Deep Brain Stimulation (DBS)
n=10 participants at risk
Subjects' DBS surgical intervention requires implantation of two bilateral DBS system: a CM thalamic lead,an ECOG strip leads, one neurostimulator implanted in the chest per hemisphere.
Neurostimulator and leads system includes a programmer with a telemetry interface, and a patient remote control to check device status. The programmer is used to set up the stimulation and signal recording to retrieve data for subsequent review.
The DBS system will provide continuous stimulation for the 6 months following surgery. Subjects will be seen monthly for evaluation as a part of normal clinical care for DBS. At 6 months, the investigators will determine whether the subject is a candidate for responsive brain stimulation (RBS). Qualifying subjects will have the option to have their settings changed in order to participate in the RBS stimulation intervention. Subjects who do not qualify or do not participate will continue to receive this intervention for the duration of the study.
Six months post-surgery, the DBS system will be set to provide responsive stimulation for the duration of the study. Subjects will be seen every 6 months for evaluation as a part of normal clinical care for DBS.
Data gathered from the subject during the first 6 months will be used to determine if this intervention is applicable for each individual subject. Subjects who do not qualify will continue to receive the other study intervention.
|
Responsive Brain Stimulation (RBS)
n=5 participants at risk
At 6 months, the investigators will determine whether the subject is a candidate for responsive brain stimulation (RBS). Qualifying subjects will have the option to have their settings changed in order to participate in the RBS stimulation intervention. Subjects who do not qualify or do not participate will continue to receive this intervention for the duration of the study.
|
|---|---|---|
|
Nervous system disorders
akathisia
|
20.0%
2/10 • Number of events 2 • 3 years
|
0.00%
0/5 • 3 years
|
|
Immune system disorders
allergic reaction
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Psychiatric disorders
anxiety
|
40.0%
4/10 • Number of events 5 • 3 years
|
0.00%
0/5 • 3 years
|
|
Hepatobiliary disorders
cholecystitis
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Metabolism and nutrition disorders
dehydration
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Psychiatric disorders
depression
|
30.0%
3/10 • Number of events 3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Nervous system disorders
dysarthria
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
General disorders
fatique
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Vascular disorders
flushing
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
gastroenteritis
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
gastrointestinal, other - excessive salivation
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Nervous system disorders
headache
|
70.0%
7/10 • Number of events 13 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
hiccups
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Psychiatric disorders
insomnia
|
20.0%
2/10 • Number of events 2 • 3 years
|
0.00%
0/5 • 3 years
|
|
Reproductive system and breast disorders
irregular menstruation
|
10.0%
1/10 • Number of events 2 • 3 years
|
0.00%
0/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
joint range of motion decreased cervical spine
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
General disorders
localized edema
|
40.0%
4/10 • Number of events 8 • 3 years
|
0.00%
0/5 • 3 years
|
|
Psychiatric disorders
mania
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
30.0%
3/10 • Number of events 3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
nausea
|
40.0%
4/10 • Number of events 7 • 3 years
|
0.00%
0/5 • 3 years
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
10.0%
1/10 • Number of events 5 • 3 years
|
0.00%
0/5 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
neoplasms benign, malignant, and unspecified
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Nervous system disorders
neuralgia
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
General disorders
pain
|
20.0%
2/10 • Number of events 3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Nervous system disorders
parasthesia
|
30.0%
3/10 • Number of events 7 • 3 years
|
0.00%
0/5 • 3 years
|
|
Psychiatric disorders
psychiatric disorders - other, nightmares
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Psychiatric disorders
psychiatric disorders, other - tics
|
30.0%
3/10 • Number of events 5 • 3 years
|
0.00%
0/5 • 3 years
|
|
Psychiatric disorders
psychiatric disorders, other - pseudobulbar affect
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Psychiatric disorders
psychosis
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
rash acneiform
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular with pruritus
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
scalp pain
|
30.0%
3/10 • Number of events 3 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
sinus disorder
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
sinus pain
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Skin and subcutaneous tissue disorders
skin infection
|
10.0%
1/10 • Number of events 4 • 3 years
|
0.00%
0/5 • 3 years
|
|
Nervous system disorders
spasticity
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Psychiatric disorders
suicidal ideation
|
10.0%
1/10 • Number of events 2 • 3 years
|
0.00%
0/5 • 3 years
|
|
Infections and infestations
thrush
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
20.0%
2/10 • Number of events 2 • 3 years
|
0.00%
0/5 • 3 years
|
|
Injury, poisoning and procedural complications
vascular access complication
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Gastrointestinal disorders
vomiting
|
50.0%
5/10 • Number of events 7 • 3 years
|
0.00%
0/5 • 3 years
|
|
Investigations
weight gain
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
|
Injury, poisoning and procedural complications
wound dehiscence
|
10.0%
1/10 • Number of events 1 • 3 years
|
0.00%
0/5 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place