CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 30 target
Drug / intervention
Melodic Intonation Therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00903266
NCT00903266Phase 3Completed

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

Beth Israel Deaconess Medical Center·interventional·Posted May 18, 2009·Updated Sep 21, 2020

In Brief

A Phase 3 clinical trial evaluating Melodic Intonation Therapy and Speech-Repetition-Therapy for Aphasia and 4 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 18, 2009
Enrollment StartFeb 1, 2008
Primary CompletionMay 1, 2020
Study CompletionJun 1, 2020
TodayJul 2, 2026
Enrollment to primary: 12.3 yearsPosted 17.1 years ago

Interventions

Melodic Intonation Therapybehavioral

MIT emphasizes the prosody of speech through the use of slow, pitched vocalization (singing).

Speech-Repetition-Therapybehavioral

Speech-Reception-Therapy is an equally intensive, alternative verbal treatment method developed for this study.