Trial Outcomes & Findings for Identification of Optimal Stimulation Site for Cervical Dystonia Symptoms: An Exploratory Study (NCT NCT01859247)
NCT ID: NCT01859247
Last Updated: 2016-07-28
Results Overview
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to assess severity of disease. The score for this section ranges from 0 (absence of severity) to 35 (maximum severity).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment
Results posted on
2016-07-28
Participant Flow
Participant milestones
| Measure |
Subject 1
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex
|
Subject 2
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area
|
Subject 3
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex
|
Subject 4
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex
|
Subject 5
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex
|
Subject 6
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex
|
Subject 7
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area
|
Subject 8
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Identification of Optimal Stimulation Site for Cervical Dystonia Symptoms: An Exploratory Study
Baseline characteristics by cohort
| Measure |
Subject 1
n=1 Participants
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex
|
Subject 2
n=1 Participants
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area
|
Subject 3
n=1 Participants
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex
|
Subject 4
n=1 Participants
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex
|
Subject 5
n=1 Participants
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex
|
Subject 6
n=1 Participants
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex
|
Subject 7
n=1 Participants
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area
|
Subject 8
n=1 Participants
Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:
Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex
|
Total
n=8 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33 years
n=93 Participants
|
60 years
n=4 Participants
|
67 years
n=27 Participants
|
31 years
n=483 Participants
|
55 years
n=36 Participants
|
41 years
n=10 Participants
|
65 years
n=115 Participants
|
72 years
n=40 Participants
|
53 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
5 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
1 participants
n=483 Participants
|
1 participants
n=36 Participants
|
1 participants
n=10 Participants
|
1 participants
n=115 Participants
|
1 participants
n=40 Participants
|
8 participants
n=8 Participants
|
|
TWSTRS Severity (Toronto Western Spasmodic Torticollis Rating Scale)
|
20 units on a scale
n=93 Participants
|
9 units on a scale
n=4 Participants
|
8 units on a scale
n=27 Participants
|
14 units on a scale
n=483 Participants
|
21 units on a scale
n=36 Participants
|
20 units on a scale
n=10 Participants
|
12 units on a scale
n=115 Participants
|
16 units on a scale
n=40 Participants
|
15 units on a scale
n=8 Participants
|
|
Dorsal Premotor-Motor Cortical Inhibition (DPMi)
|
213 Percentage
n=93 Participants
|
127.50 Percentage
n=4 Participants
|
68.10 Percentage
n=27 Participants
|
71.60 Percentage
n=483 Participants
|
NA Percentage
n=36 Participants
|
NA Percentage
n=10 Participants
|
67.80 Percentage
n=115 Participants
|
72.30 Percentage
n=40 Participants
|
NA Percentage
n=8 Participants
|
|
Cortical Silent Period (CSP)
|
169.10 milliseconds
n=93 Participants
|
153.70 milliseconds
n=4 Participants
|
133.28 milliseconds
n=27 Participants
|
78.10 milliseconds
n=483 Participants
|
136.92 milliseconds
n=36 Participants
|
76.24 milliseconds
n=10 Participants
|
113.16 milliseconds
n=115 Participants
|
99.76 milliseconds
n=40 Participants
|
105.03 milliseconds
n=8 Participants
|
PRIMARY outcome
Timeframe: Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatmentToronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to assess severity of disease. The score for this section ranges from 0 (absence of severity) to 35 (maximum severity).
Outcome measures
| Measure |
Primary Motor Cortex rTMS
n=8 Participants
0.2Hz for 15 minutes
|
Anterior Cingulate rTMS
n=8 Participants
0.2Hz for 15 minutes:
|
Dorsal Premotor rTMS
n=8 Participants
0.2Hz for 15 minutes:
|
Supplemental Motor Area rTMS
n=8 Participants
0.2Hz for 15 minutes:
|
Sham rTMS
n=8 Participants
0.2Hz for 15 minutes:
|
|---|---|---|---|---|---|
|
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
|
-3.0 units on a scale
Standard Deviation 4.8
|
0.25 units on a scale
Standard Deviation 1.7
|
-2.9 units on a scale
Standard Deviation 3.4
|
-1.5 units on a scale
Standard Deviation 3.2
|
-0.5 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Change from baseline dPMI to post-intervention within 1 hour of treatmentPopulation: two subjects did not have dPMI measured
Outcome measures
| Measure |
Primary Motor Cortex rTMS
n=6 Participants
0.2Hz for 15 minutes
|
Anterior Cingulate rTMS
n=6 Participants
0.2Hz for 15 minutes:
|
Dorsal Premotor rTMS
n=6 Participants
0.2Hz for 15 minutes:
|
Supplemental Motor Area rTMS
n=6 Participants
0.2Hz for 15 minutes:
|
Sham rTMS
n=6 Participants
0.2Hz for 15 minutes:
|
|---|---|---|---|---|---|
|
Dorsal Premotor-motor Inhibition (dPMI)
|
57.50 percentage
Standard Deviation 40.5
|
2.10 percentage
Standard Deviation 24.5
|
21.08 percentage
Standard Deviation 42.5
|
32.21 percentage
Standard Deviation 53.5
|
19.71 percentage
Standard Deviation 80
|
SECONDARY outcome
Timeframe: Assessment completed immediately after rTMS treatment sessionThis measure will confirm the intervention tolerability by the patient. He/she scored the tolerability from 0-10, 0 being "completely tolerable" and 10 "completely intolerable."
Outcome measures
| Measure |
Primary Motor Cortex rTMS
n=8 Participants
0.2Hz for 15 minutes
|
Anterior Cingulate rTMS
n=8 Participants
0.2Hz for 15 minutes:
|
Dorsal Premotor rTMS
n=8 Participants
0.2Hz for 15 minutes:
|
Supplemental Motor Area rTMS
n=8 Participants
0.2Hz for 15 minutes:
|
Sham rTMS
n=8 Participants
0.2Hz for 15 minutes:
|
|---|---|---|---|---|---|
|
Composite Measure of Patient Rating of Symptoms and Tolerability
|
1.6 units on a scale
Standard Deviation 1.8
|
1.6 units on a scale
Standard Deviation 2.8
|
1.5 units on a scale
Standard Deviation 2.7
|
0.9 units on a scale
Standard Deviation 1.1
|
0.8 units on a scale
Standard Deviation 1.0
|
Adverse Events
Subject 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subject 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subject 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subject 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subject 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subject 6
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subject 7
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subject 8
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sarah Pirio Richardson, MD
The University of New Mexico Health Sciences Center
Phone: 505-272-3342
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place