Music Therapy + Brain Stimulation for Corticobasal Syndrome

Overseen By Kyurim Kang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Migraines, Metallic implants, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 3 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how music therapy and gentle brain stimulation might help individuals with corticobasal syndrome (CBS) improve arm and hand use. Participants will either engage in exercises with music, such as Patterned Sensory Enhancement (PSE), or combine these exercises with brain stimulation, specifically Transcranial Direct Current Stimulation (tDCS), to determine which method is more effective. The trial aims to assess whether these approaches can enhance daily function and overall quality of life for CBS patients. Eligible participants should have CBS, be right-handed, and not have conditions like migraines or metal implants. As an unphased trial, this study provides a unique opportunity to explore innovative therapies that could improve daily life for CBS patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study coordinators or your doctor.

What prior data suggests that these interventions are safe for patients with corticobasal syndrome?

Research has shown that Patterned Sensory Enhancement (PSE), a type of music therapy, is generally safe and may improve movement across various groups. A review on PSE suggests it could enhance movement abilities without major issues reported. So far, studies have not identified any serious side effects.

For Transcranial Direct Current Stimulation (tDCS), evidence indicates it is well-tolerated. Many studies have reported no serious side effects, with the most common minor issue being skin irritation where the device contacts the skin. Overall, previous research has found both PSE and tDCS treatments to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining Music Therapy and Brain Stimulation for Corticobasal Syndrome because these techniques offer unique benefits compared to existing treatments. Standard treatments often focus on managing symptoms with medications like levodopa or physical therapies. However, Patterned Sensory Enhancement (PSE) uses musical cues to stimulate movement and emotional responses, potentially enhancing motor skills and emotional well-being. Transcranial Direct Current Stimulation (tDCS) is another innovative approach that non-invasively modulates brain activity to improve cognitive and motor functions. Together, these methods offer a fresh perspective by targeting both the brain's electrical activity and the emotional-motor connection through music, which might lead to more holistic improvements for patients.

What evidence suggests that these treatments could be effective for corticobasal syndrome?

Studies have shown that music-based treatments like Patterned Sensory Enhancement (PSE) can improve hand and arm movements, particularly in conditions like Parkinson's disease, where rhythmic cues aid movement. In this trial, one group of participants will receive only PSE, while another group will receive a combination of PSE with transcranial direct current stimulation (tDCS), a gentle brain stimulation method. Research suggests that this combination can further enhance arm and hand function in various diseases. Early findings in corticobasal syndrome (CBS) showed that tDCS alone improved thinking skills, such as reaction time during tasks. Overall, these methods might offer promising ways to improve movement and thinking abilities in CBS patients. ^{1 5 6 7 8}

Who Is on the Research Team?

Alexander Pantelyat, MD

Principal Investigator

Department of Neurology, Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for right-handed individuals aged 18-89 with corticobasal syndrome (CBS). It's not suitable for those with a history of seizures, skin conditions like psoriasis or eczema, psychological/neurological disorders, pregnancy, inability to follow study procedures, adverse reactions to brain stimulation techniques, migraines, metallic implants including pacemakers or past significant head injuries.

Inclusion Criteria

You are right-handed.

I have CBS.

Exclusion Criteria

I have a history of migraines.

You have had bad reactions to previous brain stimulation treatments.

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either PSE or PSE+tDCS interventions, 30 minutes per session, twice a week for three weeks

3 weeks

6 sessions (in-person)

Follow-up

Participants are monitored for changes in upper extremity performance and other outcomes

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Patterned Sensory Enhancement (PSE)
• Transcranial Direct Current Stimulation (tDCS)

Trial Overview The study tests if music patterns (Patterned Sensory Enhancement) and non-invasive brain stimulation (transcranial Direct Current Stimulation) can improve arm function in CBS patients. Participants are divided into two groups; one receives only PSE while the other gets PSE plus tDCS over six sessions spanning three weeks.

How Is the Trial Designed?

Group I: PSE+tDCS Experimental Treatment 2 Interventions

Participants in this group will proceed with the same procedure as PSE only group, but tDCS modulation will be additionally provided.

Group II: PSE Only Experimental Treatment 1 Intervention

Participants will exercise their hands, arms, shoulders, and torso with musical cues provided by neurologic music therapist. A simple gross/fine movements and emotional level will be assessed before and after each session. During the session, participants will be measured their brainwaves using electroencephalography (EEG) to understand their neurophysiological responses. Participant's motion will be also captured to acquire kinematic quantities.

Patterned Sensory Enhancement (PSE) is already approved in United States, European Union for the following indications:

Approved in United States as Patterned Sensory Enhancement (PSE) for:

• Rehabilitation for upper extremity motor function in patients with corticobasal syndrome (CBS) and stroke

Approved in European Union as Patterned Sensory Enhancement (PSE) for:

• Rehabilitation for upper extremity motor function in patients with stroke and neurodegenerative disorders

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

Neurologic Music Therapy (NMT), particularly through Auditory Stimulation (RAS), has been shown to improve gait parameters like velocity and stride length in individuals with Parkinson's disease, based on studies dating back to the 1990s.

A small case study of three older adults with Parkinson's disease suggests that NMT may enhance communication between auditory and motor cortices, indicated by increased beta-range power and functional connectivity during motor tasks, although further research with control groups is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Neurophysiological Evidence of Altered Cortical Activity and Connectivity With Neurologic Music Therapy in Parkinson's Disease. Buard, I., Dewispelaere, WB., Thaut, M., et al.[2021]

Neurologic music therapy utilizes music to help patients with nervous system disorders by activating brain processes that can improve non-musical functions, making it a valuable alternative treatment.

Clinical studies show that rehabilitation incorporating music significantly outperforms traditional methods without music, particularly in treating conditions like stroke, brain injury, and dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music therapy in neurological rehabilitation settings. Galińska, E.[2017]

Music therapy can significantly enhance rehabilitation outcomes for patients with brain injuries, such as those with Parkinson's disease and stroke, by improving motor functions, speech recovery, and cognitive abilities.

The positive effects of music on the brain are linked to reduced stress and depression, as well as activation of the brain's reward system, leading to both structural and functional changes in brain activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of music in brain rehabilitation. A systematic review]. Sihvonen, AJ., Leo, V., Särkämö, T., et al.[2018]

Combining anodal tDCS stimulation with autobiographically-salient music significantly improved working memory performance in older adults compared to tDCS alone or music alone, as shown in a study with 14 participants aged 64-81.

While no behavioral differences were found in recognition memory tasks, neural changes were observed with the combination of tDCS and music, suggesting that personalized music may enhance the cognitive benefits of neurostimulation in aging individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation combined with listening to preferred music on memory in older adults. Chow, R., Noly-Gandon, A., Moussard, A., et al.[2023]

Transcranial direct current stimulation (tDCS) applied to the primary auditory cortex significantly enhanced auditory sensory discrimination, as measured by the mismatch negativity (MMN) brain response, in a pilot study with 12 healthy participants.

The effects of tDCS were particularly notable in individuals with lower baseline MMN amplitudes and smaller pitch changes, suggesting that tDCS could be a promising tool for improving auditory processing, although further research is needed to understand its potential in treating auditory deficits in clinical populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcranial direct current stimulation (tDCS) on MMN-indexed auditory discrimination: a pilot study. Impey, D., Knott, V.[2019]

This study investigates the effects of combining transcranial direct current stimulation (tDCS) with neurologic music therapy (NMT) on improving arm and hand performance in individuals with corticobasal syndrome (CBS), using a randomized design with six sessions over three weeks.

The trial aims to assess the efficacy of this noninvasive approach by measuring motor, cognitive, and emotional outcomes, potentially offering new rehabilitation strategies for CBS patients, a group that currently has limited treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurologic music therapy combined with EEG-tDCS for upper motor extremity performance in patients with corticobasal syndrome: Study protocol for a novel approach. Kang, K., Stenum, J., Roemmich, RT., et al.[2023]

Transcranial alternating current stimulation (tACS) significantly enhances gamma-band activity in response to auditory stimuli, improving both the magnitude and timing of these responses, while transcranial direct current stimulation (tDCS) does not have this effect.

Both tACS and tDCS strengthen the gamma phase connectome, which is important for synchronizing brain activity, suggesting that these noninvasive neurostimulation techniques can modify clinical biomarkers related to neurological and psychiatric disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of auditory gamma-band responses using transcranial electrical stimulation. Jones, KT., Johnson, EL., Tauxe, ZS., et al.[2021]

Music-based interventions (MBIs) engage various brain circuits and show potential therapeutic benefits for different health conditions, as supported by research from the National Institutes of Health.

Utilizing advanced technologies like human brain imaging and animal models, researchers can analyze how MBIs affect motor, emotional, and cognitive functions, paving the way for more effective evidence-based applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music and Brain Circuitry: Strategies for Strengthening Evidence-Based Research for Music-Based Interventions. Chen, WG., Iversen, JR., Kao, MH., et al.[2023]

The study found that combining cathodal transcranial cerebellar Direct Current Stimulation (tcDCS) with music listening significantly improved spatial attention in healthy subjects, effectively compensating for a natural leftward bias in attention (pseudoneglect).

In contrast, anodal or sham tcDCS did not produce any significant effects on spatial attention when paired with music or white noise, supporting the idea that the effectiveness of brain stimulation can depend on the initial state of the brain, which could have implications for rehabilitation strategies in spatial disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shaping pseudoneglect with transcranial cerebellar direct current stimulation and music listening. Picazio, S., Granata, C., Caltagirone, C., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05073471

Music and Brain Stimulation for Upper Extremity ... This study seeks to assess the possibility that music-based intervention and non-invasive brain stimulation may improve outcomes in CBS patients for patients' ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12293833/

The Effects of Music-Based Patterned Sensory Enhancement ... Additionally, the use of external rhythmic auditory cues has been shown to improve hand and arm movements in individuals with Parkinson's disease (PD) [14,15,16 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422003846

Neurologic music therapy combined with EEG-tDCS for ... Combining transcranial direct current stimulation (tDCS) with rehabilitation training has been shown to improve upper-limb performance in other disease models.

4. researchgate.net researchgate.net/publication/366402190_Neurologic_music_therapy_combined_with_EEG-tDCS_for_upper_motor_extremity_performance_in_patients_with_corticobasal_syndrome_Study_protocol_for_a_novel_approach

Neurologic music therapy combined with EEG-tDCS for ... Combining transcranial direct current stimulation (tDCS) with rehabilitation training has been shown to improve upper-limb performance in other disease models.

5. withpower.com withpower.com/trial/phase-syndrome-10-2021-c391e

Music Therapy + Brain Stimulation for Corticobasal ... This study is designed to investigate how musical patterns (e.g., patterned sensory enhancement, PSE) and non-invasive brain stimulation (e.g., ...

6. mdpi.com mdpi.com/2076-3425/15/7/664

The Effects of Music-Based Patterned Sensory ... This scoping review suggests that PSE holds significant potential for improving motor function across a range of clinical populations.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36549380/

Neurologic music therapy combined with EEG-tDCS for ... Here, we describe the protocol investigating whether tDCS with neurologic music therapy (NMT) (patterned sensory enhancement and therapeutic instrumental music ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10814683/

Patterned Sensory Enhancement, a Music Rehabilitation ... Patterned sensory enhancement, a music rehabilitation therapy for elderly patients with neuromotor deficit during the COVID-19 pandemic: a pilot study.