Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

NCT05706831 | Recruiting

• 1 other identifier: 345
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Consciousness; Stroke

Keywords

music stimulation; tDCS; Aphasia; Neglect; DOC; Stroke

Outcome Measures

Primary Outcomes (15)

• Neuropsychological outcomes

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

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

• Neuropsychological outcomes

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

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

• Neuropsychological outcomes

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

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

• Neuropsychological outcomes

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

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

• 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).

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

• Neuropsychological outcomes

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

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

• Neuropsychological outcomes

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

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

• Neuropsychological outcomes

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

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

• Neuropsychological outcomes

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

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

• Neuropsychological outcomes

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

  Change from baseline Barrage Test at 2 weeks and 4 weeks

• Neuropsychological outcomes

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

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

• Neuropsychological outcomes

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

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

• Neuropsychological outcomes

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

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

• Neuropsychological outcomes

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

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

• 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."

  Change from baseline oscillation at 2 weeks and 4 weeks

Secondary Outcomes (6)

• Caregiver psychological distress

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

• Caregiver psychological distress

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

• Caregiver psychological distress

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

• Caregiver psychological distress

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

• Caregiver psychological distress

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

Study Arms (3)

Group 1

EXPERIMENTAL

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.

Other: Combinatory effect of music stimulation and neurostimulation

Group 2

EXPERIMENTAL

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.

Other: Combinatory effect of music stimulation and neurostimulation

Group 3

EXPERIMENTAL

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.

Other: Combinatory effect of music stimulation and neurostimulation

Interventions

Combinatory effect of music stimulation and neurostimulation OTHER

music

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Post-stroke aphasia
• Post-stroke neglect
• Patients with disorders of consciusness (DOC)

You may not qualify if:

• No auditory injury
• no hystory of neurological disease
• No hystory of psychiatric disease
• Previous stroke
• use of alcohol and drugs
• premorbid dementia

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• University of Bari Aldo Moro: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri

Bari, Ba, 70025, Italy

RECRUITING

Related Publications (1)

• Spaccavento S, Carraturo G, Brattico E, Matarrelli B, Rivolta D, Montenegro F, Picciola E, Haumann NT, Jespersen KV, Vuust P, Losavio E. Musical and electrical stimulation as intervention in disorder of consciousness (DOC) patients: A randomised cross-over trial. PLoS One. 2024 May 31;19(5):e0304642. doi: 10.1371/journal.pone.0304642. eCollection 2024.

  PMID: 38820520 DERIVED

MeSH Terms

Conditions

Consciousness Disorders; Stroke; Aphasia

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Speech Disorders; Language Disorders; Communication Disorders

Central Study Contacts

Simona Spaccavento

CONTACT

+393332783524; simona.spaccavento@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: January 31, 2023
• Study Start: September 1, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 4, 2025

Record last verified: 2025-04

Locations

IT (1)