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Trial record 6 of 129 for:    "spinocerebellar ataxia type 2" OR "Spinocerebellar Ataxias"

Transcranial Magnetic Stimulation in Spino-Cerebellar Ataxia (TMS)

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ClinicalTrials.gov Identifier: NCT01975909
Recruitment Status : Completed
First Posted : November 5, 2013
Results First Posted : May 30, 2017
Last Update Posted : May 30, 2017
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Alvaro Pascual-Leone, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Spinocerebellar Ataxia
Intervention Device: Transcranial Magnetic Stimulation
Enrollment 20

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Transcranial Magnetic Stimulation (TMS) Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description

A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Transcranial Magnetic Stimulation (TMS) Sham Transcranial Magnetic Stimulation Total
Hide Arm/Group Description

A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
52.3  (10.1) 48.6  (4.8) 50.6  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
8
  80.0%
8
  80.0%
16
  80.0%
Male
2
  20.0%
2
  20.0%
4
  20.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)
Hide Description Assess 8 items: gait, stance, sitting, speech, dysmetria, kinetic tremor, pro- and supinations of the hand, and the heel-shin slide. Each item is scored by the physician on a 4 to 8 numerical scale based upon the amount of dysfunction observed while performing the task. The maximum possible score for the total scale is 40. Lower scores of SARA represents better task performance.
Time Frame Baseline and 1 week post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Magnetic Stimulation (TMS) Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description:

A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage change
-25.9  (16.4) -27.8  (9.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transcranial Magnetic Stimulation (TMS), Sham Transcranial Magnetic Stimulation
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments We hypothesized that the real TMS would improve the performance of SARA (i.e., greater percent decrease of SARA score from baseline) as compared to the sham TMS.
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Percent Change From Baseline to Post Treatment on the Timed 25-Foot Walk
Hide Description A quantitative assessment of mobility and leg function. Two trials of patients walking along a 25ft course as quickly and safely as possible. Time taken to complete course will be recorded and averaged across trials.
Time Frame Baseline and 1 week post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Magnetic Stimulation (TMS) Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description:

A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage change of maximum gait speed
7.8  (12.0) 2.2  (25.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transcranial Magnetic Stimulation (TMS), Sham Transcranial Magnetic Stimulation
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments We hypothesized that the real TMS would improve the performance of 25-foot walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Percent Change From Baseline to Post Treatment on the 9-hole Peg Test
Hide Description The test consists of a block with nine holes, into which the subject places and then removes 9 pegs. The time taken to complete the test will be recorded.
Time Frame Baseline and 1 week post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Magnetic Stimulation (TMS) Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description:

A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage change
0.7  (5.1) -6.7  (7.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transcranial Magnetic Stimulation (TMS), Sham Transcranial Magnetic Stimulation
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments We hypothesized that the real TMS would improve the performance of 9-hole peg test (i.e., greater percent decrease of time to complete the test from baseline) as compared to the sham TMS.
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Other Pre-specified Outcome
Title Percent Change From Baseline to Post Treatment on Gait Speed in 90 Second Walking Test
Hide Description Two 90 second trials of walking at a preferred speed along a 80x4m indoor hallway. A wireless Noraxon DTS system (Noraxon Inc, Scottsdale, AZ) will be used simultaneously and continuously record bilateral foot placements, 3-dimensional trunk accelerations, and lower-extremity surface electromyography of eight muscles.
Time Frame Baseline and 1 week post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Magnetic Stimulation (TMS) Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description:

A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage change
4.2  (17.9) 5.3  (13.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transcranial Magnetic Stimulation (TMS), Sham Transcranial Magnetic Stimulation
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments We hypothesized that the real TMS would improve the performance of 90-second walking test (i.e., greater percent increase of walking speed from baseline) as compared to the sham TMS.
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Other Pre-specified Outcome
Title Percent Change From Baseline to Post Treatment on Standing Postural Control
Hide Description Postural control - assessed by measuring standing postural sway (ie., center-of pressure fluctuations) during two, 30second trials of standing with eyes open on a stationary force platform (AMTI, Watertown, MA).
Time Frame Baseline and 1 week post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Magnetic Stimulation (TMS) Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description:

A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage change
-21.5  (14.9) 13.2  (29.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transcranial Magnetic Stimulation (TMS), Sham Transcranial Magnetic Stimulation
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments We hypothesized that the real TMS would improve the standing postural control stability (i.e., greater percent decrease increase of postural sway speed from baseline) as compared to the sham TMS.
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Other Pre-specified Outcome
Title Percent Change From Baseline to Post Treatment on Mobility and Turning
Hide Description Mobility and turning is assessed by the timed up-and-go test (Podsiadlo & Richardson, 1991). The participant will be seated in an armed chair. On the word "go," the subject will stand up using the arm rests if needed, walk (with assistive device if needed) around a cone placed three meters in front of the chair, return and sit down as quickly as possible.
Time Frame Baseline and 1 week post treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Transcranial Magnetic Stimulation (TMS) Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description:

A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: percentage change
-12.8  (11.7) -9.3  (15.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transcranial Magnetic Stimulation (TMS), Sham Transcranial Magnetic Stimulation
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments We hypothesized that the real TMS would improve the performance of TUG test (i.e., greater percent decrease of time to complete TUG test from baseline) as compared to the sham TMS.
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Transcranial Magnetic Stimulation (TMS) Sham Transcranial Magnetic Stimulation
Hide Arm/Group Description

A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.

Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.

All-Cause Mortality
Transcranial Magnetic Stimulation (TMS) Sham Transcranial Magnetic Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Transcranial Magnetic Stimulation (TMS) Sham Transcranial Magnetic Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Transcranial Magnetic Stimulation (TMS) Sham Transcranial Magnetic Stimulation
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/10 (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: Brad Manor, Ph.D.
Organization: Beth Israel Deaconess Medical Center
Phone: 617-971-5332
Responsible Party: Alvaro Pascual-Leone, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01975909     History of Changes
Other Study ID Numbers: 2013P000233
1R21NS085491-01 ( U.S. NIH Grant/Contract )
First Submitted: September 24, 2013
First Posted: November 5, 2013
Results First Submitted: March 2, 2017
Results First Posted: May 30, 2017
Last Update Posted: May 30, 2017