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Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

Primary Purpose

Disorder of Consciousness, Stroke

Status

Recruiting

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Combinatory effect of music stimulation and neurostimulation

About this trial

This is an interventional treatment trial for Disorder of Consciousness focused on measuring music stimulation, tDCS, Aphasia, Neglect, DOC, Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age > 18 years Post-stroke aphasia Post-stroke neglect Patients with disorders of consciusness (DOC) Exclusion Criteria: No auditory injury no hystory of neurological disease No hystory of psychiatric disease Previous stroke use of alcohol and drugs premorbid dementia

Sites / Locations

Istituti Clinici Scientifici MaugeriRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1

Group 2

Group 3

Arm Description

Group 1 will receive tEs combined with music stimulation for 2 weeks, 1 week of wash out, then sham stimulation combined with noise (placebo) for other 2 weeks.

Group 2 will receive sham stimulation and noise (placebo) for the first 2 weeks, then 1 week wash out, and finally tEs and music stimulation for other 2 weeks.

Group 3 will receive only music stimulation and sham stimulation for 2 weeks, 1 week of wash out, then sham stimulation and noise (placebo) for another 2 weeks.

Outcomes

Primary Outcome Measures

Neuropsychological outcomes

-Coma Recovery Scale-Revised (CRS-R) - (0-23). High score means a better outcome.

Neuropsychological outcomes

Disability Rating Scale (DRS) - (0-29). High score means a worse outcome.

Neuropsychological outcomes

Rancho Levels of Cognitive Functioning (LCF) - (1-8). High score means a better outcome.

Neuropsychological outcomes

Glasgow Outcome Scale- Extended (GOS-E) - (1-8). High score means a better outcome.

Neuropsychological outcomes

Aachener Aphasie Test (AAT). This test includes six subtests: spontaneous speech, token test, repetition, written language, naming, and comprehension. Spontaneous speech is structured in six parts (0-30). High score means a better performance; Token test is composed by 50 items; for the score the number of error id considered (0-50). Repetition sub test is composed by 50 items; for each item the score range from 0 to 3; high score means better outcome (0-150). Written language subtest is composed by 30 items; for each item the score range from 0 to 3; high score means better outcome (0-90). Naming subtest is composed by 40 items; for each item the score range from 0 to 3; high score means better outcome (0-120). Comprehension subtest is composed by 40 items; for each item the score range from 0 to 3; high score means better outcome (0-120).

Neuropsychological outcomes

Italian version of Functional Outcome Questionnaire for Aphasie (FOQ-A) - (32-160). High score means a better outcome.

Neuropsychological outcomes

Functional Assessment Measure - Cognitive subscale - (FAM) - (14-98); high score means a better outcome.

Neuropsychological outcomes

Quality of Life questionnaire for Aphasics (QLQA) - (0-148); High score means a better outcome.

Neuropsychological outcomes

The semi-structured scale for functional evaluation of personal neglect - (0-9); High score means a worse outcome.

Neuropsychological outcomes

Barrage test (0-36). High score means a better outcome.

Neuropsychological outcomes

Letter cancellation test - (0-104). High score means a better outcome.

Neuropsychological outcomes

Sentence reading test (0-6). High score means a worse outcome.

Neuropsychological outcomes

Wundt-Jastrow area illusion test (0-20). High score means a worse outcome.

Neuropsychological outcomes

The semi structured scale for the functional evaluation of extrapersonal neglect (0-9). High score means a worse outcome.

Neurophysiological outcome

The ratio of fast (8-30 Hz, α-β) to slow (2-8 Hz, δ-θ) oscillation amplitude at the midline electrodes (Fz, Cz, Pz, Oz) will be measured and compared pre- and post intervention."

Secondary Outcome Measures

Caregiver psychological distress

Back depression Inventory II (BDI II) - (0-63). High score means a worse outcome.

Caregiver psychological distress

State-trait anxiety inventory (STAI-Y). It is composed by two scales: STAI-Y State (20-80) and STAI-Y Trait (20-80). High score means a worse outcome.

Caregiver psychological distress

Psychophysiological Questionnaire (30-120). WHOQOL-BREF.

Caregiver psychological distress

Prolonged grief disorder -12 (PG-12) - (11-55). High score means a worse outcome.

Caregiver psychological distress

Family strain questionnaire (FSQ) - (1-44). High score means a worse outcome.

Caregiver psychological distress

better outcome.

Full Information

NCT ID

NCT05706831

First Posted

November 16, 2022

Last Updated

January 30, 2023

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborators

University of Bari Aldo Moro, University of Aarhus

1. Study Identification

Unique Protocol Identification Number

NCT05706831

Brief Title

Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

Official Title

Music Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2022 (Actual)

Primary Completion Date

August 30, 2025 (Anticipated)

Study Completion Date

August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborators

University of Bari Aldo Moro, University of Aarhus

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this clinical trial is to evaluate the efficacy of a musical interventionand non-invasive brain stimulation in neurological patients. The main questions it aims to answer are: to evaluate the residual neuroplastic processes in DOC state related to music exposure to determine the putative modulation of the aforementioned processes and the clinical outcome of DOC patients by non-pharmacological strategies, i.e., electric (tDCS) and music stimulation to evaluate the impact of this intervention on caregiver's burden and psychological distress. Participants will be randomly assigned to one of three different music-listening intervention groups. Primary outcomes will be clinical, that is based on the neurologist's observations of clinical improvement, and neurophysiological, collected pre-intervention, post-intervention and post-placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Disorder of Consciousness, Stroke

Keywords

music stimulation, tDCS, Aphasia, Neglect, DOC, Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Three groups of neurological patients will be considered for the study. For each group, participants will be randomly allocated to one of three intervention groups. These interventions will consist of a combination of musical stimulation, sham stimulation, tDCS and noise.

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

Group 1 will receive tEs combined with music stimulation for 2 weeks, 1 week of wash out, then sham stimulation combined with noise (placebo) for other 2 weeks.

Arm Title

Group 2

Arm Type

Experimental

Arm Description

Group 2 will receive sham stimulation and noise (placebo) for the first 2 weeks, then 1 week wash out, and finally tEs and music stimulation for other 2 weeks.

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Group 3 will receive only music stimulation and sham stimulation for 2 weeks, 1 week of wash out, then sham stimulation and noise (placebo) for another 2 weeks.

Intervention Type

Other

Intervention Name(s)

Combinatory effect of music stimulation and neurostimulation

Intervention Description

music

Primary Outcome Measure Information:

Title

Neuropsychological outcomes

Description

-Coma Recovery Scale-Revised (CRS-R) - (0-23). High score means a better outcome.

Time Frame

Change from baseline Coma Recovery Scale- Revised at 2 weeks and 4 weeks

Title

Neuropsychological outcomes

Description

Disability Rating Scale (DRS) - (0-29). High score means a worse outcome.

Time Frame

Change from baseline Disability Rating Scale at 2 weeks and 4 weeks

Title

Neuropsychological outcomes

Description

Rancho Levels of Cognitive Functioning (LCF) - (1-8). High score means a better outcome.

Time Frame

Change from baseline Rancho Levels of Cognitive Functioning at 2 weeks and 4 weeks

Title

Neuropsychological outcomes

Description

Glasgow Outcome Scale- Extended (GOS-E) - (1-8). High score means a better outcome.

Time Frame

Change from baseline Glasgow Outcome Scale- Extended at 2 weeks and 4 weeks

Title

Neuropsychological outcomes

Description

Time Frame

Change from baseline Aachener Aphasie Test at 2 weeks and 4 weeks

Title

Neuropsychological outcomes

Description

Italian version of Functional Outcome Questionnaire for Aphasie (FOQ-A) - (32-160). High score means a better outcome.

Time Frame

Change from baseline Italian version of Functional Outcome Questionnaire for Aphasie at 2 weeks and 4 weeks

Title

Neuropsychological outcomes

Description

Functional Assessment Measure - Cognitive subscale - (FAM) - (14-98); high score means a better outcome.

Time Frame

Change from baseline Functional Assessment Measure - Cognitive subscale at 2 weeks and 4 weeks

Title

Neuropsychological outcomes

Description

Quality of Life questionnaire for Aphasics (QLQA) - (0-148); High score means a better outcome.

Time Frame

Change from baseline Quality of Life Questionnaire for aphasics at 2 weeks and 4 weeks

Title

Neuropsychological outcomes

Description

The semi-structured scale for functional evaluation of personal neglect - (0-9); High score means a worse outcome.

Time Frame

Change from baseline The semi-structured scale for functional evaluation of personal neglect at 2 weeks and 4 weeks

Title

Neuropsychological outcomes

Description

Barrage test (0-36). High score means a better outcome.

Time Frame

Change from baseline Barrage Test at 2 weeks and 4 weeks

Title

Neuropsychological outcomes

Description

Letter cancellation test - (0-104). High score means a better outcome.

Time Frame

Change from baseline Letter cancellation test at 2 weeks and 4 weeks

Title

Neuropsychological outcomes

Description

Sentence reading test (0-6). High score means a worse outcome.

Time Frame

Change from baseline Sentence reading test at 2 weeks and 4 weeks

Title

Neuropsychological outcomes

Description

Wundt-Jastrow area illusion test (0-20). High score means a worse outcome.

Time Frame

Change from baseline Wundt-Jastrow area illusion test at 2 weeks and 4 weeks

Title

Neuropsychological outcomes

Description

The semi structured scale for the functional evaluation of extrapersonal neglect (0-9). High score means a worse outcome.

Time Frame

Change from baseline The semi structured scale for the functional evaluation of extrapersonal neglect at 2 weeks and 4 weeks

Title

Neurophysiological outcome

Description

The ratio of fast (8-30 Hz, α-β) to slow (2-8 Hz, δ-θ) oscillation amplitude at the midline electrodes (Fz, Cz, Pz, Oz) will be measured and compared pre- and post intervention."

Time Frame

Change from baseline oscillation at 2 weeks and 4 weeks

Secondary Outcome Measure Information:

Title

Caregiver psychological distress

Description

Back depression Inventory II (BDI II) - (0-63). High score means a worse outcome.

Time Frame

Change from baseline Back depression Inventory II at 2 weeks and 4 weeks

Title

Caregiver psychological distress

Description

State-trait anxiety inventory (STAI-Y). It is composed by two scales: STAI-Y State (20-80) and STAI-Y Trait (20-80). High score means a worse outcome.

Time Frame

Change from baseline State-trait anxiety inventory; at 2 weeks and 4 weeks

Title

Caregiver psychological distress

Description

Psychophysiological Questionnaire (30-120). WHOQOL-BREF.

Time Frame

Change from baseline Questionario psicofisiologico (CBA) at 2 weeks and 4 weeks

Title

Caregiver psychological distress

Description

Prolonged grief disorder -12 (PG-12) - (11-55). High score means a worse outcome.

Time Frame

Change from baseline Prolonged grief disorder -12 at 2 weeks and 4 weeks

Title

Caregiver psychological distress

Description

Family strain questionnaire (FSQ) - (1-44). High score means a worse outcome.

Time Frame

Change from baseline Family strain questionnaire at 2 weeks and 4 weeks

Title

Caregiver psychological distress

Description

better outcome.

Time Frame

Change from baseline Wolrd health organization - quality of life at 2 weeks and 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Simona Spaccavento

Phone

+393332783524

simona.spaccavento@icsmaugeri.it

Facility Information:

Facility Name

Istituti Clinici Scientifici Maugeri

City

Bari

State/Province

ZIP/Postal Code

70025

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Simona Spaccavento

12. IPD Sharing Statement

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Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

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