Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation

The goal of this Interventional Study is to develop and test the Indian Adaptation of Melodic Intonation Therapy (MIT) for Indian patients in with post-stroke Non-Fluent Aphasia (PSNFA). The main question[s] it aims to answer are: • To develop the MIT Indian Adaptation tool and check its feasibility • To compare the MIT with standard speech rehabilitation in patient with PSNFA. Participants will undergo Speech Rehabilitation according to the developed module and the standard treatment will be given in the comparator arm. The speech recovery at 12 weeks will be compared in both treatment arms.

Study Overview

• Status: Recruiting
• Conditions: Aphasia, Broca; Stroke Rehabilitation
• Intervention / Treatment: Other: Speech rehabilitation

Detailed Description

The study will be done in two stages:

• Stage 1 (Intervention formulation): A battery for therapy will be formulated with the help of SLT in conjunction with the expert(s) in Indian music, neurologist, and physiologist. In a series of physical and online meetings, the duration, frequency, and content of the therapy programme will be formulated. The stage(s) at which NIRS will be conducted will also be decided. This will not involve any patient recruitment and should be finished in three months.
• Stage 2 (Feasibility phase): The feasibility run will be done in 10 eligible patients. With further adaptations depending upon the experience in the feasibility phase, the pilot phase will be conducted, in which the treatment arms will be randomized.

• Stage 2 (Pilot phase): Assuming standard error of measurement for participants with aphasia as 4.33 points with a 5-point difference considered clinically meaningful for the Western Aphasia Battery (WAB), and considering that no such prior study is there, 30 patients in intervention and control arm would be initially taken. Therefore, the total sample size 10+30+30=70 patients.

  • The randomization will be done in 1:1 ratio, via a computer-generated random number sequence which will be in a sealed opaque envelope. The allocation will be concealed, and the treatment arm will be revealed after the patient has been screened and has consented for the study.
  • The outcome assessment will be by a blinded assessor, who will be a co-investigator in the study.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Deepti Vibha; Phone Number: +91-9868398263; Email: deeptivibha@aiims.edu

Study Locations

• India
  • Delhi, India, 110029
    • Recruiting
    • Institute of Human Behavior and Allied Sciences
    • Contact: Deepti Vibha; Phone Number: 09868398263; Email: deeptivibha@gmail.com
  • Delhi
    • New Delhi, Delhi, India, 110029
      • Recruiting
      • Safdarjung Hospital
      • Contact: Deepti Vibha; Phone Number: 09868398263; Email: deeptivibha@gmail.com
    • New Delhi, Delhi, India, 110029
      • Recruiting
      • All India Institute of Medical Sciences, New Delhi
      • Contact: Deepti Vibha; Phone Number: 09868398263; Email: deeptivibha@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

All of the following

1. Age ≥18 years of age
2. Stroke with non-fluent aphasia, within one year of ictus
3. Imaging evidence suggestive of ischemic or hemorrhagic stroke of dominant hemisphere
4. Patient is alert and able to follow simple commands (should not have global aphasia)
5. Motivated caregiver
6. Informed and signed consent

Exclusion Criteria:

Any of the following:

1. Patients with a history of a previous stroke other than the index event, which can explain the aphasia.
2. Any clinical condition (e.g., short life expectancy, coexisting disease) or other characteristics that preclude appropriate follow-up in the study (e.g., distant residence, no family support)
3. Patients participating in any therapeutic intervention clinical trials evaluating poststroke recovery
4. Use of psychotropic drugs that interfere with patient evaluation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention arm will be given the Music Therapy, the Indian language adapted module	Other: Speech rehabilitation; Melodic Intonation Therapy- Indian Adaptation module which will be developed in the pilot phase
Active Comparator: Active comparator; The active comparator arm will be given the standard speech rehabilitation.	Other: Speech rehabilitation; Melodic Intonation Therapy- Indian Adaptation module which will be developed in the pilot phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Western Aphasia Battery Score	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Western Aphasia Battery Score	4 weeks
functional Near Red Spectroscopy measures	8 weeks
modified Rankin Score	8 weeks
Fugl Meyer Assessment Scores	8 weeks

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, New Delhi
• Collaborators: Vardhman Mahavir Medical College And Safdarjung Hospital; Institute of Human Behavior and Allied Sciences; Indian Institute of Technology, New Delhi

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: November 28, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Melodic Intonation Therapy; Post stroke non-fluent aphasia; Indian Adaptation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Communication Disorders; Language Disorders; Speech Disorders; Stroke; Aphasia; Aphasia, Broca
• Other Study ID Numbers: I-1623

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will be shared upon request to the PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No