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

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00903266
Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
30
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3
148
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Behavioral: Melodic Intonation Therapy
  • Behavioral: Speech-Repetition-Therapy
Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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
Study Start Date :
Feb 1, 2008
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Correct Information Units (CIU)/min and CIUs/phrase elicited during spontaneous speech [Baseline (x2), midpoint of therapy, end of therapy, 4 weeks after end of therapy]

Secondary Outcome Measures

  1. 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 [baseline (x2), midpoint of therapy, end of therapy, 4 weeks after end of therapy]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Beth Israel Deaconess Medical Center / Harvard Medical School Boston Massachusetts United States 02215

Sponsors and Collaborators

  • Beth Israel Deaconess Medical Center
  • National Institute on Deafness and Other Communication Disorders (NIDCD)

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Gottfried Schlaug, Associate Professor of Neurology; Staff Neurologist, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00903266
Other Study ID Numbers:
  • DC008796
  • 3R01DC008796-02S1
  • R01DC008796
First Posted:
May 18, 2009
Last Update Posted:
Sep 21, 2020
Last Verified:
Sep 1, 2020
Keywords provided by Gottfried Schlaug, Associate Professor of Neurology; Staff Neurologist, Beth Israel Deaconess Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2020