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Identification of Optimal Stimulation Site for Cervical Dystonia Symptoms: An Exploratory Study

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ClinicalTrials.gov Identifier: NCT01859247
Recruitment Status : Completed
First Posted : May 21, 2013
Results First Posted : July 28, 2016
Last Update Posted : July 28, 2016
Sponsor:
Collaborators:
Dystonia Coalition
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
University Health Network, Toronto
Information provided by (Responsible Party):
Sarah Pirio Richardson, University of New Mexico

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cervical Dystonia
Spasmodic Torticollis
Intervention Device: rTMS
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Subject 1 Subject 2 Subject 3 Subject 4 Subject 5 Subject 6 Subject 7 Subject 8
Hide Arm/Group Description

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

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

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

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

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

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

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

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

Period Title: Overall Study
Started 1 1 1 1 1 1 1 1
Completed 1 1 1 1 1 1 1 1
Not Completed 0 0 0 0 0 0 0 0
Arm/Group Title Subject 1 Subject 2 Subject 3 Subject 4 Subject 5 Subject 6 Subject 7 Subject 8 Total
Hide Arm/Group Description

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

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

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

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

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 1 1 1 1 1 1 1 1 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 8 participants
33
(33 to 33)
60
(60 to 60)
67
(67 to 67)
31
(31 to 31)
55
(55 to 55)
41
(41 to 41)
65
(65 to 65)
72
(72 to 72)
53
(31 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 8 participants
Female
0
   0.0%
0
   0.0%
1
 100.0%
0
   0.0%
1
 100.0%
0
   0.0%
1
 100.0%
0
   0.0%
3
  37.5%
Male
1
 100.0%
1
 100.0%
0
   0.0%
1
 100.0%
0
   0.0%
1
 100.0%
0
   0.0%
1
 100.0%
5
  62.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 8 participants
1 1 1 1 1 1 1 1 8
TWSTRS Severity (Toronto Western Spasmodic Torticollis Rating Scale)   [1] 
Mean (Full Range)
Unit of measure:  Units on a scale
Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 8 participants
20
(20 to 20)
9
(9 to 9)
8
(8 to 8)
14
(14 to 14)
21
(21 to 21)
20
(20 to 20)
12
(12 to 12)
16
(16 to 16)
15
(8 to 20)
[1]
Measure Description: 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).
Dorsal Premotor-Motor Cortical Inhibition (DPMi)  
Mean (Full Range)
Unit of measure:  Percentage
Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 8 participants
213
(213 to 213)
127.50
(127.50 to 127.50)
68.10
(68.10 to 68.10)
71.60
(71.60 to 71.60)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
67.80
(67.80 to 67.80)
72.30
(72.30 to 72.30)
NA [2] 
(NA to NA)
[1]
Pre-DPMI not obtained
[2]
Total not calculated because data are not available (NA) in one or more arms.
Cortical Silent Period (CSP)  
Mean (Full Range)
Unit of measure:  Milliseconds
Number Analyzed 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 1 participants 8 participants
169.10
(169.10 to 169.10)
153.70
(153.70 to 153.70)
133.28
(133.28 to 133.28)
78.10
(78.10 to 78.10)
136.92
(136.92 to 136.92)
76.24
(76.24 to 76.24)
113.16
(113.16 to 113.16)
99.76
(99.76 to 99.76)
105.03
(76.24 to 169.10)
1.Primary Outcome
Title Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Hide Description 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).
Time Frame Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Motor Cortex rTMS Anterior Cingulate rTMS Dorsal Premotor rTMS Supplemental Motor Area rTMS Sham rTMS
Hide Arm/Group Description:
0.2Hz for 15 minutes
0.2Hz for 15 minutes:
0.2Hz for 15 minutes:
0.2Hz for 15 minutes:
0.2Hz for 15 minutes:
Overall Number of Participants Analyzed 8 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.0  (4.8) 0.25  (1.7) -2.9  (3.4) -1.5  (3.2) -0.5  (1.1)
2.Secondary Outcome
Title Dorsal Premotor-motor Inhibition (dPMI)
Hide Description [Not Specified]
Time Frame Change from baseline dPMI to post-intervention within 1 hour of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
two subjects did not have dPMI measured
Arm/Group Title Primary Motor Cortex rTMS Anterior Cingulate rTMS Dorsal Premotor rTMS Supplemental Motor Area rTMS Sham rTMS
Hide Arm/Group Description:
0.2Hz for 15 minutes
0.2Hz for 15 minutes
0.2Hz for 15 minutes
0.2Hz for 15 minutes
0.2Hz for 15 minutes
Overall Number of Participants Analyzed 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: percentage
57.50  (40.5) 2.10  (24.5) 21.08  (42.5) 32.21  (53.5) 19.71  (80)
3.Secondary Outcome
Title Composite Measure of Patient Rating of Symptoms and Tolerability
Hide Description This 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."
Time Frame Assessment completed immediately after rTMS treatment session
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Primary Motor Cortex rTMS Anterior Cingulate rTMS Dorsal Premotor rTMS Supplemental Motor Area rTMS Sham rTMS
Hide Arm/Group Description:
0.2Hz for 15 minutes
0.2Hz for 15 minutes:
0.2Hz for 15 minutes:
0.2Hz for 15 minutes:
0.2Hz for 15 minutes:
Overall Number of Participants Analyzed 8 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.6  (1.8) 1.6  (2.8) 1.5  (2.7) 0.9  (1.1) 0.8  (1.0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subject 1 Subject 2 Subject 3 Subject 4 Subject 5 Subject 6 Subject 7 Subject 8
Hide Arm/Group Description

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

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

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

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

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

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

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

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

All-Cause Mortality
Subject 1 Subject 2 Subject 3 Subject 4 Subject 5 Subject 6 Subject 7 Subject 8
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Subject 1 Subject 2 Subject 3 Subject 4 Subject 5 Subject 6 Subject 7 Subject 8
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subject 1 Subject 2 Subject 3 Subject 4 Subject 5 Subject 6 Subject 7 Subject 8
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Sarah Pirio Richardson, MD
Organization: The University of New Mexico Health Sciences Center
Phone: 505-272-3342
Responsible Party: Sarah Pirio Richardson, University of New Mexico
ClinicalTrials.gov Identifier: NCT01859247     History of Changes
Other Study ID Numbers: UNM 657
U54NS065701 ( U.S. NIH Grant/Contract )
First Submitted: May 9, 2013
First Posted: May 21, 2013
Results First Submitted: January 8, 2016
Results First Posted: July 28, 2016
Last Update Posted: July 28, 2016