Music Intervention and Transcranial Electrical Stimulation for Treating Neurological Diseases

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18 years

• Post-stroke aphasia

• Post-stroke neglect

• Patients with disorders of consciusness (DOC)

Locations
Other Locations
Italy
Istituti Clinici Scientifici Maugeri
RECRUITING
Bari
Contact Information
Primary
Simona Spaccavento
simona.spaccavento@icsmaugeri.it
+393332783524
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 90
Treatments
Experimental: Group 1
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.
Experimental: Group 2
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.
Experimental: Group 3
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.
Related Therapeutic Areas
Sponsors
Leads: Istituti Clinici Scientifici Maugeri SpA
Collaborators: University of Bari Aldo Moro, University of Aarhus

This content was sourced from clinicaltrials.gov

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