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Trial record 6 of 122 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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Transcranial Magnetic Stimulation (TMS)

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.

Sham Transcranial Magnetic Stimulation

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.


Participant Flow:   Overall Study
    Transcranial Magnetic Stimulation (TMS)   Sham Transcranial Magnetic Stimulation
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Transcranial Magnetic Stimulation (TMS)

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.

Sham Transcranial Magnetic Stimulation

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 Total of all reporting groups

Baseline Measures
   Transcranial Magnetic Stimulation (TMS)   Sham Transcranial Magnetic Stimulation   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.3  (10.1)   48.6  (4.8)   50.6  (7.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      8  80.0%      8  80.0%      16  80.0% 
Male      2  20.0%      2  20.0%      4  20.0% 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 


  Outcome Measures

1.  Primary:   Percent Change From Baseline to Post Treatment on the Scale for the Assessment and Rating of Ataxia (SARA)   [ Time Frame: Baseline and 1 week post treatment ]

2.  Secondary:   Percent Change From Baseline to Post Treatment on the Timed 25-Foot Walk   [ Time Frame: Baseline and 1 week post treatment ]

3.  Secondary:   Percent Change From Baseline to Post Treatment on the 9-hole Peg Test   [ Time Frame: Baseline and 1 week post treatment ]

4.  Other Pre-specified:   Percent Change From Baseline to Post Treatment on Gait Speed in 90 Second Walking Test   [ Time Frame: Baseline and 1 week post treatment ]

5.  Other Pre-specified:   Percent Change From Baseline to Post Treatment on Standing Postural Control   [ Time Frame: Baseline and 1 week post treatment ]

6.  Other Pre-specified:   Percent Change From Baseline to Post Treatment on Mobility and Turning   [ Time Frame: Baseline and 1 week post treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: bmanor@bidmc.harvard.edu



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