Trial Outcomes & Findings for Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome (NCT NCT01817517)

Last Updated: 2026-01-28

Results Overview

Investigators will assess deep brain stimulation effects on tic frequency and severity using the change in Yale Global Tic Severity Scale (YGTSS) in this population of Tourette syndrome patients. The scales range from 0-100, higher scores indicate greater tic severity and impairment.

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

1 year after neurostimulator implantation

Results posted on

2026-01-28

Participant Flow

Participant milestones

Participant milestones
Measure	Deep Brain Stimulation Implant Unblinded treatment arm, thalamic DBS for Tourette syndrome. Medtronic Activa Deep Brain Stimulation System
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Deep Brain Stimulation Implant n=2 Participants Unblinded treatment arm, thalamic DBS for Tourette syndrome. Medtronic Activa Deep Brain Stimulation System
Age, Categorical <=18 years	0 Participants n=2 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=2 Participants
Age, Categorical >=65 years	1 Participants n=2 Participants
Sex: Female, Male Female	0 Participants n=2 Participants
Sex: Female, Male Male	2 Participants n=2 Participants
Region of Enrollment United States	2 Participants n=2 Participants
Yale Global Tic Severity Scale (YGTSS) Total Score Subject 1	68 units on a scale n=1 Participants • value for each subject is reported
Yale Global Tic Severity Scale (YGTSS) Total Score Subject 2	71 units on a scale n=1 Participants • value for each subject is reported
Yale Brown Obsessive Compulsive Score Subject 1	0 units on a scale n=1 Participants • value for each subject is reported
Yale Brown Obsessive Compulsive Score Subject 2	19 units on a scale n=1 Participants • value for each subject is reported
WHO Adult ADHD Self-Report Scale (ASRS) Subject 1	5 units on a scale n=1 Participants • value for each subject is reported
WHO Adult ADHD Self-Report Scale (ASRS) Subject 2	4 units on a scale n=1 Participants • value for each subject is reported
Grooved Pegboard Test - Dominant Hand Subject 1	80 seconds n=1 Participants • value for each subject is reported
Grooved Pegboard Test - Dominant Hand Subject 2	58.5 seconds n=1 Participants • value for each subject is reported
Judgement of Line Orientation Subject 1	13 score on a scale n=1 Participants • value for each subject is reported
Judgement of Line Orientation Subject 2	27 score on a scale n=1 Participants • value for each subject is reported
Time on Trail Making Test (TMT- A) Subject 1	40 seconds n=1 Participants • value for each subject is reported
Time on Trail Making Test (TMT- A) Subject 2	14 seconds n=1 Participants • value for each subject is reported
Time on Trail Making Test (TMT-B) Subject 1	480 seconds n=1 Participants • value for each subject is reported
Time on Trail Making Test (TMT-B) Subject 2	25 seconds n=1 Participants • value for each subject is reported
Hopkins Verbal Learning Test - Delayed Free Recall Subject 1	2 items recalled n=1 Participants • value for each subject is reported
Hopkins Verbal Learning Test - Delayed Free Recall Subject 2	12 items recalled n=1 Participants • value for each subject is reported
Verbal Fluency Test (COWAT) Subject 1	11 total # of words (FAS) n=1 Participants • value for each subject is reported
Verbal Fluency Test (COWAT) Subject 2	46 total # of words (FAS) n=1 Participants • value for each subject is reported

PRIMARY outcome

Timeframe: 1 year after neurostimulator implantation

Population: values are per participant

Outcome measures

Outcome measures
Measure	Deep Brain Stimulation Implant n=2 Participants Unblinded treatment arm, thalamic DBS for Tourette syndrome. Medtronic Activa Deep Brain Stimulation System
Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) Subject 1	44 Score on a scale
Change From Baseline in the Yale Global Tic Severity Scale (YGTSS) Subject 2	61 Score on a scale

PRIMARY outcome

Timeframe: 1 year after neurostimulator implantation.

We will assess the incidence of adverse device effects (ADEs) as defined by the Code of Federal Regulations (21 CFR 812.3) at 1 year. Number of participants free of adverse events by 1year post implantation is reported.

Outcome measures

Outcome measures
Measure	Deep Brain Stimulation Implant n=2 Participants Unblinded treatment arm, thalamic DBS for Tourette syndrome. Medtronic Activa Deep Brain Stimulation System
Number of Participants Free of Adverse Device Effects (ADEs).	2 Participants

SECONDARY outcome

Timeframe: 1 year after neurostimulator implantation.

Population: values are per participant

We will assess deep brain stimulation effects on obsessive compulsive disorder symptoms using the Yale-Brown Obsessive Compulsive Scale (Baseline score - Final score). Score range 0-40, higher scores indicate greater severity of OCD symptoms.

Outcome measures

Outcome measures
Measure	Deep Brain Stimulation Implant n=2 Participants Unblinded treatment arm, thalamic DBS for Tourette syndrome. Medtronic Activa Deep Brain Stimulation System
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale Subject 2	5 score on a scale
Change From Baseline in the Yale-Brown Obsessive Compulsive Scale Subject 1	0 score on a scale

SECONDARY outcome

Timeframe: 1 year after neurostimulator implantation.

Population: values are per participant

We will assess deep brain stimulation effects on ADHD symptoms as measured by the WHO Adult ADHD Self-Report Scale (ASRS).

Outcome measures

Outcome measures
Measure	Deep Brain Stimulation Implant n=2 Participants Unblinded treatment arm, thalamic DBS for Tourette syndrome. Medtronic Activa Deep Brain Stimulation System
Change From Baseline in the WHO Adult ADHD Self-Report Scale (ASRS) Subject 1	3 score on a scale
Change From Baseline in the WHO Adult ADHD Self-Report Scale (ASRS) Subject 2	-4 score on a scale

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year after neurostimulator implantation.

Population: Participants with data collected

We will assess deep brain stimulation effects on Grooved Pegboard test as a part of the neurocognitive assessment of this group of Tourette syndrome patients. We will measure change in seconds 1y after stimulation activation (of the dominant hand).

Outcome measures

Outcome measures
Measure	Deep Brain Stimulation Implant n=1 Participants Unblinded treatment arm, thalamic DBS for Tourette syndrome. Medtronic Activa Deep Brain Stimulation System
Change From Baseline in the Grooved Pegboard Test	4 seconds (reduction)

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year after neurostimulator implantation.

We will assess deep brain stimulation effects on the Judgement of Line Orientation test as a part of the neurocognitive assessment of this group of Tourette syndrome patients.

Outcome measures

Outcome measures
Measure	Deep Brain Stimulation Implant n=1 Participants Unblinded treatment arm, thalamic DBS for Tourette syndrome. Medtronic Activa Deep Brain Stimulation System
Change From Baseline in the Judgement of Line Orientation	1 score on a scale

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year after neurostimulator implantation.

We will assess deep brain stimulation effects on the Trailmaking Test (A) as a part of the neurocognitive assessment of this group of Tourette syndrome patients.

Outcome measures

Outcome measures
Measure	Deep Brain Stimulation Implant n=1 Participants Unblinded treatment arm, thalamic DBS for Tourette syndrome. Medtronic Activa Deep Brain Stimulation System
Change From Baseline in the Trailmaking Test - A	10 seconds

OTHER_PRE_SPECIFIED outcome

Timeframe: 1year

Change in seconds at 1 year on the Trail Making Test - Part B (Baseline score - Final Score). The Time on Trails B (TMT) is scored by recording the number of seconds to complete each part of the test, with greater time indicating greater impairment. Normative ranges are used for interpretation and are stratified by age and education. TMT-B is an alternating alphabetical and numeral sequence. For TMT-B, the average is around 75 seconds, and a deficient score can be over 273 seconds.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year after neurostimulator implantation.

We will assess deep brain stimulation effects on the change Hopkins Verbal Learning Test (delayed recall) as a part of the neurocognitive assessment of this group of Tourette syndrome patients. Note, a positive value indicates an improvement, a negative number worsening.

Outcome measures

Outcome measures
Measure	Deep Brain Stimulation Implant n=1 Participants Unblinded treatment arm, thalamic DBS for Tourette syndrome. Medtronic Activa Deep Brain Stimulation System
Change From Baseline in the Hopkins Verbal Learning Test	-2 change # of items recalled

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year after neurostimulator implantation.

We will assess deep brain stimulation effects on the change of Verbal Fluency Test (COWAT) as a part of the neurocognitive assessment of this group of Tourette syndrome patients. Note, a positive value indicates an improvement, a negative number worsening.

Outcome measures

Outcome measures
Measure	Deep Brain Stimulation Implant n=1 Participants Unblinded treatment arm, thalamic DBS for Tourette syndrome. Medtronic Activa Deep Brain Stimulation System
Change From Baseline in the Verbal Fluency Test (COWAT)	-6 change in total # of words (FAS)

Adverse Events

Deep Brain Stimulation Implant

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Deep Brain Stimulation Implant n=2 participants at risk Unblinded treatment arm, thalamic DBS for Tourette syndrome. Medtronic Activa Deep Brain Stimulation System
Product Issues Lead Fracture	50.0% 1/2 • Number of events 1 • Immediately post implantation up to study termination (approximately 6 years 4 months)
Nervous system disorders Meningoencephalitis	50.0% 1/2 • Number of events 1 • Immediately post implantation up to study termination (approximately 6 years 4 months)

Other adverse events

Adverse event data not reported

Additional Information

Ankur Butala MD

Johns Hopkins Medicine

Phone: 410-502-0133

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place