Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Melodic-Intonation-Therapy and Speech-Repetition-Therapy for Patients With Non-fluent Aphasia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00903266
First received: May 15, 2009
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

We are doing this clinical trial in order to evaluate two different treatments for non-fluent aphasia: Melodic Intonation Therapy (MIT) and Speech Repetition Therapy (SRT). MIT uses a simple form of singing, while SRT uses intensive repetition of a set of words and phrases. We want to see which intensive form of treatment is more effective in leading to an improvement in speech output compared to a no-therapy control period, and whether either treatment can cause changes in brain activity during speaking and changes in brain structure. We will use a technique known as functional Magnetic Resonance Imaging (fMRI) to measure blood flow changes in the brain and structural MRI that assess brain anatomy and connections between brain regions. We will use fMRI to assess brain activity while a patient speaks, sings, and hums. We will assess changes in brain activity and in brain structure by comparing scans done prior to treatment to scans obtained after treatment and we will also examine changes between treatment groups. We will correlate changes in brain activity and brain structure with changes in language test scores.


Condition Intervention Phase
Aphasia
Stroke
Cerebrovascular Accident
Apoplexy
Cerebral Infarction
Behavioral: Melodic Intonation Therapy
Behavioral: Speech-Repetition-Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral and Neural Correlates of Melodic-Intonation-Therapy (MIT) and Speech-Repetition-Therapy (SRT) for Patients With Non-fluent Aphasia

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Correct Information Units (CIU)/min and CIUs/phrase elicited during spontaneous speech [ Time Frame: Baseline (x2), midpoint of therapy, end of therapy, 4 weeks after end of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1) Items named on a standard picture naming test; 2) timed automatic speech; 3) linguistically-based measures of phrase and sentence analysis; 4) functional and structural imaging measures [ Time Frame: baseline (x2), midpoint of therapy, end of therapy, 4 weeks after end of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MIT
Melodic Intonation Therapy
Behavioral: Melodic Intonation Therapy
MIT emphasizes the prosody of speech through the use of slow, pitched vocalization (singing).
Active Comparator: SRT
Speech-Repetition-Therapy
Behavioral: Speech-Repetition-Therapy
Speech-Reception-Therapy is an equally intensive, alternative verbal treatment method developed for this study.
No Intervention: NTC
No-Therapy Control; Patients in this arm will be re-randomized to the two active arms at the end of the NTC period.

Detailed Description:

One of the few accepted treatments for severe non-fluent aphasia is Melodic Intonation Therapy (MIT). Inspired by the common clinical observation that patients can actually sing the lyrics of a song better than they can speak the same words, MIT emphasizes the prosody of speech through the use of slow, pitched vocalization (singing), and has been shown to lead to significant improvements in propositional speech beyond the actual treatment period. It has been hypothesized that this effect is due to the gradual recruitment of right-hemispheric language regions for normal speech production, and this is further supported by our functional magnetic resonance imaging (fMRI) pilot data. Although the MIT-induced treatment effect has been shown in several small case series, it is not clear whether the effect is due to the intensity of the treatment or to the unique, components of MIT that are not found in other, non-intonation-based interventions. Thus, our overall aim is to test our hypothesis that MIT's rehabilitative effect is achieved by using its melodic and rhythmic elements to engage and/or unmask the predominantly right-hemispheric brain regions capable of supporting expressive language function. In order to test this hypothesis, we have developed an experimental design that includes the randomization of chronic stroke patients with persistent, moderate to severe non-fluent aphasia into three parallel groups receiving 1) 75 sessions of Melodic Intonation Therapy (approximately 15 weeks), 2) 75 sessions of an equally intensive, alternative verbal treatment method developed for this study (Speech Repetition Therapy), or 3) an equal period of No Therapy. All patients will undergo two pre-therapy and two post-therapy behavioral assessments in addition to the pre- and post-therapy fMRI studies and structural MRI studies examining the neural correlates of overtly spoken and sung words and phrases.This design allows us to 1) examine the efficacy of MIT over No Therapy, 2) examine the effects of elements specific to MIT (e.g., melodic intonation and rhythmic tapping) by comparing it to a control intervention (SRT) that is similar in structure and intensity of treatment, 3) compare post-therapy effects with pre-therapy baseline variations, and 4) examine post-treatment maintenance effects. Our primary speech outcome measure will be the number of Correct Information Units (CIU)/min produced during spontaneous speech. Secondary outcome measures include correctly named items on standard picture naming tests, timed automatic speech, and linguistically-based measures of phrase and sentence analysis.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 21-80 years of age
  2. first-time ischemic left-hemispheric stroke or cerebrovascular accident
  3. at least 12 months out from first ischemic stroke
  4. right-handed (prior to stroke)
  5. diagnosis of non-fluent or dysfluent aphasia

Exclusion Criteria:

  1. older than 80 years of age
  2. more than 1 stroke
  3. presence of metal or metallic or electronic devices that cannot be exposed to the MRI environment
  4. a terminal medical condition; history of major neurological or psychiatric diseases (e.g. epilepsy; meningitis, encephalitis)
  5. use of psychoactive drugs/medications such as antidepressants, antipsychotic, stimulants
  6. active participation in other stroke recovery trials testing experimental interventions
  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: NCT00903266

Contacts
Contact: Gottfried Schlaug, MD, PhD 617-632-8926 gschlaug@bidmc.harvard.edu
Contact: Andrea Norton, BM 617-632-8926 aphasia_recovery@yahoo.com

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center / Harvard Medical School Recruiting
Boston, Massachusetts, United States, 02215
Contact: Gottfried Schlaug, MD, PhD    617-632-8926    gschlaug@bidmc.harvard.edu   
Contact: Andrea Norton, BM    617-632-8926    aphasia_recovery@yahoo.com   
Principal Investigator: Gottfried Schlaug, MD, PhD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Gottfried Schlaug, MD, PhD Beth Israel Deaconess Medical Center / Harvard Medical School
Study Director: Andrea Norton, BM Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Publications:
Schlaug G, Marchina S, Norton A. From Singing to Speaking: Why Patients with Broca's Aphasia can sing and how that may lead to recovery of expressive language functions. Music Perception 25:315-323, 2008.
Norton A, Zipse L, Marchina S, Schlaug G. Melodic Intonation Therapy: How it is done and why it might work. Annals of New York Academy of Sciences 2009, in press.

Responsible Party: Gottfried Schlaug, MD, PhD, Beth Israel Deaconess Medical Center / Harvard Medical School
ClinicalTrials.gov Identifier: NCT00903266     History of Changes
Other Study ID Numbers: DC008796, 3R01DC008796-02S1, RO1 DC008796
Study First Received: May 15, 2009
Last Updated: June 30, 2011
Health Authority: United States: Federal Government

Keywords provided by Beth Israel Deaconess Medical Center:
Aphasia
Speech Impairment
Stroke
Cerebrovascular Accident
Cerebral Infarction
Brain Ischemia
Brain Infarction
Cerebrovascular Disorder

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

ClinicalTrials.gov processed this record on November 25, 2014