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

September 17, 2020 updated by: Gottfried Schlaug, Beth Israel Deaconess Medical Center

Behavioral and Neural Correlates of Melodic-Intonation-Therapy (MIT) and Speech-Repetition-Therapy (SRT) for Patients With Non-fluent Aphasia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center / Harvard Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline (x2), midpoint of therapy, end of therapy, 4 weeks after end of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
baseline (x2), midpoint of therapy, end of therapy, 4 weeks after end of therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

May 15, 2009

First Submitted That Met QC Criteria

May 15, 2009

First Posted (Estimate)

May 18, 2009

Study Record Updates

Last Update Posted (Actual)

September 21, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC008796
  • 3R01DC008796-02S1 (U.S. NIH Grant/Contract)
  • R01DC008796 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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