Music Intervention and Transcranial Electrical Stimulation for Neurological Diseases

Not Applicable

Recruiting

• Conditions: Stroke; Disorder of Consciousness
• Interventions: Other: Combinatory effect of music stimulation and neurostimulation

• Registration Number: NCT05706831
• Lead Sponsor: Istituti Clinici Scientifici Maugeri SpA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-01
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-01-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-04
• Primary Completion: 2025-08-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Combinatory effect of music stimulation and neurostimulation	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	Combinatory effect of music stimulation and neurostimulation	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	Combinatory effect of music stimulation and neurostimulation	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.

Primary Outcome Measures

Name	Time	Method
Neuropsychological outcomes	Change from baseline The semi structured scale for the functional evaluation of extrapersonal neglect at 2 weeks and 4 weeks	The semi structured scale for the functional evaluation of extrapersonal neglect (0-9). High score means a worse outcome.
Neurophysiological outcome	Change from baseline oscillation at 2 weeks and 4 weeks	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

Name	Time	Method
Caregiver psychological distress	Change from baseline Wolrd health organization - quality of life at 2 weeks and 4 weeks	better outcome.

Trial Locations

Locations (1)

Istituti Clinici Scientifici Maugeri; 🇮🇹 Bari, Ba, Italy