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Primed vs. Unprimed rTMS in Chronic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01757821
Recruitment Status : Completed
First Posted : December 31, 2012
Results First Posted : December 1, 2017
Last Update Posted : December 1, 2017
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Stroke
Interventions: Device: real 6-Hz primed low-frequency rTMS
Device: Sham 6-Hz Primed low-frequency rTMS
Device: real 1-Hz rTMS only

  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
All subjects received all 3 interventions

Reporting Groups
  Description
6-Hz Priming

real 6-Hz primed low-frequency rTMS

real 6-Hz primed low-frequency rTMS: 10 minutes of 6-Hz stimulation (real priming) followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region

Sham 6-Hz Primed low-frequency rTMS

real 1-Hz rTMS only

real 1-Hz rTMS only: 20 minutes of low-frequency rTMS delivered to the nonstroke primary motor region

Sham 6-Hz Primed low-frequency rTMS: 10 minutes of sham priming stimulation followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region


Participant Flow:   Overall Study
    6-Hz Priming
STARTED   11 [1] 
COMPLETED   10 [2] 
NOT COMPLETED   1 
Adverse Event                1 
[1] 11 subjects
[2] 10 subjects



  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
Real 6-Hz Priming Sham 6-Hz Priming Real 1-Hz rTMS Only

real 6-Hz primed low-frequency rTMS

real 6-Hz primed low-frequency rTMS:

Sham 6-Hz Primed low-frequency rTMS

real 1-Hz rTMS only


Baseline Measures
   Real 6-Hz Priming Sham 6-Hz Priming Real 1-Hz rTMS Only 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      9  81.8% 
>=65 years      2  18.2% 
Age 
[Units: Years]
Mean (Standard Deviation)
 66  (9.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      3  27.3% 
Male      8  72.7% 
Region of Enrollment 
[Units: Participants]
 
United States   11 


  Outcome Measures

1.  Primary:   Change in Cortical Excitability: Paired-Pulse   [ Time Frame: Change from Baseline to 20 minutes ]


  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: James Carey
Organization: University of Minnesota
phone: 612-626-2746
e-mail: carey007@umn.edu



Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01757821     History of Changes
Other Study ID Numbers: BrainPrime
First Submitted: December 18, 2012
First Posted: December 31, 2012
Results First Submitted: December 4, 2015
Results First Posted: December 1, 2017
Last Update Posted: December 1, 2017