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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Aphasia
Stroke
Device: Magstim SuperRapid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post-Stroke Aphasia and rTMS Treatment Study

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: January 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rTMS
3 weeks of nerTMS
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
Sham Comparator: 1 week of Sham Treatment + 2 weeks of nerTMS
1 week of Sham Treatment + 2 weeks of nerTMS
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
Sham Comparator: 2 weeks of Sham Treatment +1 week of nerTMS
2 weeks of Sham Treatment +1 week of nerTMS
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
Placebo Comparator: Control Group
3 weeks of Sham Treatment
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: CIAT + rTMS
2 weeks of nerTMS enhanced by 1 hour of daily CIAT; both therapies will be administered in open-label fashion.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512264

Contacts
Contact: Jerzy Szaflarski, MD, PhD 205-934-3866 szaflaj@uab.edu
Contact: Amber Martin 205-934-3866 anm26aka@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Amber Martin    205-934-3866    anm26aka@uab.edu   
Principal Investigator: Jerzy P Szaflarski, MD, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Jerzy P Szaflarski, MD, PhD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Jerzy P Szaflarski, Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01512264     History of Changes
Other Study ID Numbers: RO1 HD068488
Study First Received: January 10, 2012
Last Updated: July 3, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
Aphasia
Stroke
functional Magnetic resonance imaging
fMRI
Language recovery after stroke
constraint induced aphasia therapy
CIAT
Repetitive transcranial magnetic stimulation
rTMS

Additional relevant MeSH terms:
Aphasia
Stroke
Cerebral Infarction
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 31, 2014