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Transcranial Magnetic Stimulation to Improve Speech in Aphasia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00608582
First Posted: February 6, 2008
Last Update Posted: January 31, 2017
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.
Collaborators:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Harvard Medical School
University of Pennsylvania
Information provided by (Responsible Party):
Margaret Naeser, Boston University
Results First Submitted: September 22, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Aphasia
Cerebrovascular Stroke
Intervention: Device: Transcranial Magnetic Stimulation, Repetitive

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
July 2002-March 2013. Recruited in hospital setting and outreach with affiliated and local clinics VA Boston Healthcare System, Boston, MA; Hospital of the University of Pennsylvania, Philadelphia, PA

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Assessed for eligibility by telephone screen, or in-office visit. Assessment included review of medical history. Total Excluded (n = 38) Not meeting inclusion criteria (n = 31) Declined to participate (n = 2) Other reasons (n = 5)

Reporting Groups
  Description
Real rTMS

These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.

Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.

Sham rTMS

These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.

There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.

The patients then receive a series of 10 Real rTMS treatments.

Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.


Participant Flow:   Overall Study
    Real rTMS   Sham rTMS
STARTED   14   11 
COMPLETED   10   7 
NOT COMPLETED   4   4 
Lost to Follow-up                2                0 
No Best Response in Phase 1 located                1                1 
Illicit Drug Use                1                0 
Early stage Design Change                0                3 



  Baseline Characteristics
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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.
Number of participants randomized to each treatment arm

Reporting Groups
  Description
Real rTMS

These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.

Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.

Sham rTMS

These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.

The patients then receive a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.

Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.

Total Total of all reporting groups

Baseline Measures
   Real rTMS   Sham rTMS   Total 
Overall Participants Analyzed 
[Units: Participants]
 14   11   25 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.1  (7.6)   60.8  (11)   59.28  (9.1) 
Gender 
[Units: Participants]
Count of Participants
     
Female      3  21.4%      2  18.2%      5  20.0% 
Male      11  78.6%      9  81.8%      20  80.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      1   9.1%      1   4.0% 
Not Hispanic or Latino      14 100.0%      10  90.9%      24  96.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   7.1%      0   0.0%      1   4.0% 
White      13  92.9%      11 100.0%      24  96.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   14   11   25 
Months Poststroke Onset [1] 
[Units: Months]
Mean (Standard Deviation)
 66  (40)   51  (37)   59  (39) 
[1] Number of months at entry after stroke


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Picture Naming   [ Time Frame: Baseline and 2 months after the last rTMS treatment session ]

2.  Primary:   Phrase Length   [ Time Frame: Baseline and 2 months after the last rTMS treatment session ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Margaret Naeser, PhD
Organization: VA Boston Healthcare System and Boston University School of Medicine
phone: 857-364-4030
e-mail: mnaeser@bu.edu


Publications of Results:

Other Publications:
Naeser MA, Martin PI, Ho M, Treglia E, Kaplan E, Baker EH, and Pascual-Leone A. Transcranial Magnetic Stimulation and Aphasia Research. Book Chapter, Advances in the Neural Substrates of Language: Toward a Synthesis of Basic Science and Clinical Research. Vol 2: Language Processing in the Brain: Special Populations. Miriam Faust (Ed.), Malden, MA: Wiley-Blackwell, 2012.


Responsible Party: Margaret Naeser, Boston University
ClinicalTrials.gov Identifier: NCT00608582     History of Changes
Other Study ID Numbers: NIH-DC05672
R01DC005672 ( U.S. NIH Grant/Contract )
Boston Medical Ctr IRB-H22484 ( Other Identifier: Boston University School of Medicine )
VA Boston Healthcare IRB-1145 ( Other Identifier: VA Boston Healthcare System )
First Submitted: January 24, 2008
First Posted: February 6, 2008
Results First Submitted: September 22, 2016
Results First Posted: January 31, 2017
Last Update Posted: January 31, 2017