Post-Stroke Aphasia and Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment Study (PART)

This study is currently recruiting participants.
Verified January 2014 by University of Alabama at Birmingham
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Jerzy P Szaflarski, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01512264
First received: January 10, 2012
Last updated: January 15, 2014
Last verified: January 2014

January 10, 2012
January 15, 2014
January 2012
January 2017   (final data collection date for primary outcome measure)
Improvements in aphasia testing from baseline to immediately post- and 3 months post-intervention. [ Time Frame: Within 1 week before the first nerTMS treatment, after the 1st and 2nd week of nerTMS treatment, Within 1 week after the last nerTMS treatment, and 3 months after the last nerTMS treatment (nerTMS or nerTMS+CIAT) ] [ Designated as safety issue: No ]
Quantitative AT will include: Boston Naming Test, Controlled Oral Word Association Test, Semantic Fluency Test, Complex Ideation subtest from the Boston Diagnostic Aphasia Examination, Peabody Picture Vocabulary Test IV. Two subtests from Western Aphasia Battery-R will be used to differentiate between aphasia and apraxia of speech11 Qualitative AT of subjects' communicative abilities via two discourse tasks: the picture description task from the BDAE-3 and a storytelling task using the wordless picture book Picnic.
Same as current
Complete list of historical versions of study NCT01512264 on ClinicalTrials.gov Archive Site
To use fMRI to assess changes from the baseline visit to study completion in language lateralization in response to nerTMS [ Time Frame: Within 1 week befroe the first nerTMS, Within 1 week after the last nerTMS, and 3 months after the last nerTMS treatment (nerTMS or nerTMS+CIAT) ] [ Designated as safety issue: No ]
We will use fMRI to assess changes in language lateralization in response to nerTMS and nerTMS and CIAT combined.
Same as current
Not Provided
Not Provided
 
Post-Stroke Aphasia and Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment Study
Post-Stroke Aphasia and rTMS Treatment Study

In this study the investigators will examine the efficacy of (1) navigated excitatory repetitive transcranial magnetic stimulation (nerTMS) and (2) a combination of nerTMS and constraint induced aphasia therapy (CIAT) as post-stroke aphasia rehabilitation methods. The investigators expect that these new types of rehabilitation, either nerTMS alone or in combination with CIAT, will help patients with aphasia return to their lives as they were prior to the stroke.

Aphasia after stroke is associated with high mortality, significant motor impairment, and severe limitations in social participation. During the past decade, therapies administered by stroke teams have made great strides to limit the motor impairments caused by stroke. Unfortunately, progress in aphasia rehabilitation has not experienced the same rapid advancement. This proposal is based on preliminary evidence from our recently completed pilot study which showed that navigated excitatory repetitive transcranial magnetic stimulation (nerTMS) targeted to residual activity in the affected hemisphere has a significant beneficial effect on post-stroke aphasia recovery.1 The main aim of this study is to conduct a double-blind, sham-controlled, dose-response nerTMS treatment trial in subjects with chronic aphasia. By conducting this comparative trial, we will provide clinical (qualitative and quantitative) and imaging evidence that nerTMS improves language function after stroke when compared to standard treatment (ST). The findings will have implications for patients with post-stroke aphasia in that once the study is completed and the results are available, rehabilitation specialists may be able to change their practice pattern by offering an additional tool to aid patients in recovering their language skills with improved participation in society and enhanced quality of life.

To fill the gap in our therapeutic arsenal for aphasia, we propose a study with the following specific aims: (1) to determine the comparative efficacy and optimal dosing of nerTMS on aphasia recovery using a randomized, double-blind, sham-controlled study design. Subjects (15/group) will be randomly assigned to 4 treatment groups: (a) 3 weeks of nerTMS, (b) 1 week of ST + 2 weeks of nerTMS, (c) 2 weeks of ST +1 week of nerTMS, or (d) 3 weeks of ST (control group). This design will allow systematic evaluation of the efficacy of nerTMS and will determine its most optimal dose for language recovery. Short- and long-term outcomes will be evaluated with aphasia testing (AT) and fMRI; (2) to use fMRI to assess changes in language lateralization in response to nerTMS. We will examine the relationship between the degree of pre-nerTMS language lateralization (fMRI) with the post-nerTMS language outcomes (AT) and determine whether fMRI language lateralization can predict AT performance following nerTMS targeted to the left middle cerebral artery (LMCA) stroke areas; (3) to explore the possible synergistic effect of constraint induced aphasia therapy (CIAT) plus nerTMS on aphasia recovery in a group of 20 LMCA stroke patients. These subjects will receive 2 weeks of nerTMS enhanced by 1 hour of daily CIAT; both therapies will be administered in an open-label fashion. Patients will be evaluated with fMRI and AT as above and compared to the arm "b" of the double-blind study and to CIAT data collected in an ongoing study (R01 NS048281). This aim will gather preliminary data regarding the possible synergistic effects of nerTMS and behavioral intervention.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Aphasia
  • Stroke
Device: Magstim SuperRapid
This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
Other Name: Repetitive Transcrainial Magnetic Stimulation, rTMS
  • Experimental: rTMS
    3 weeks of nerTMS
    Intervention: Device: Magstim SuperRapid
  • Sham Comparator: 1 week of Sham Treatment + 2 weeks of nerTMS
    1 week of Sham Treatment + 2 weeks of nerTMS
    Intervention: Device: Magstim SuperRapid
  • Sham Comparator: 2 weeks of Sham Treatment +1 week of nerTMS
    2 weeks of Sham Treatment +1 week of nerTMS
    Intervention: Device: Magstim SuperRapid
  • Placebo Comparator: Control Group
    3 weeks of Sham Treatment
    Intervention: Device: Magstim SuperRapid
  • Experimental: CIAT + rTMS
    2 weeks of nerTMS enhanced by 1 hour of daily CIAT; both therapies will be administered in open-label fashion.
    Intervention: Device: Magstim SuperRapid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
January 2017
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 19 years
  • LMCA stroke as indicated by the presence of aphasia and MRI lesion in the LMCA distribution
  • Moderate aphasia (Token Test score between 40th and 90th percentile)
  • Fluency in English
  • Provision of written informed consent by the patient and/or the next of kin

Exclusion Criteria:

  • Age less than 18 years
  • Underlying degenerative or metabolic disorder or supervening medical illness
  • Severe depression or other psychiatric disorder
  • Positive pregnancy test in women of childbearing age
  • Any contraindication to MRI/fMRI at 3T (i.e., intracranial metal implants, claustrophobia)
  • Any contraindication to nerTMS (e.g., seizures or epilepsy)
Both
19 Years and older
No
Contact: Jerzy Szaflarski, MD, PhD 205-934-3866 szaflaj@uab.edu
Contact: Amber Martin 205-934-3866 anm26aka@uab.edu
United States
 
NCT01512264
RO1 HD068488
Yes
Jerzy P Szaflarski, University of Alabama at Birmingham
University of Alabama at Birmingham
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Jerzy P Szaflarski, MD, PhD University of Alabama at Birmingham
University of Alabama at Birmingham
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP