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

Trial Summary

What is the purpose of this trial?

This study is designed to investigate how musical patterns (e.g., patterned sensory enhancement, PSE) and non-invasive brain stimulation (e.g., transcranial direct current stimulation, tDCS) are effective to improve functional upper extremity performances in patients with corticobasal syndrome (CBS). 20 individuals with CBS will be randomly assigned to either PSE group (n= 10) or PSE+tDCS (n=10) group. Both interventions are 30 minutes long, twice a week for three weeks (a total of 6 sessions). Participants' self-reported and measurable outcomes including upper extremity function, kinematic quantities, quality of life, mood, cognitive level, and brain activity (e.g. electroencephalography, EEG) will be assessed in the baseline, pre- and post- each session, and follow-up phase. This study seeks to assess the possibility that music-based intervention and non-invasive brain stimulation may improve outcomes in CBS patients for patients' non-invasive but cost-effective rehabilitation settings in the future.

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 data supports the effectiveness of the treatment Music Therapy + Brain Stimulation for Corticobasal Syndrome?

Research shows that combining transcranial direct current stimulation (tDCS) with music therapy can improve motor performance in conditions like Parkinson's disease and stroke. Music therapy techniques, such as rhythmic auditory stimulation, have been found to enhance motor coordination and cognitive functions by activating brain areas involved in movement and memory. ^{1 2 3 4 5}

Is the combination of music therapy and brain stimulation safe for humans?

Research on transcranial direct current stimulation (tDCS) combined with music therapy suggests it is generally safe for humans, as studies have shown it can improve cognitive functions and motor performance without significant adverse effects. However, more research is needed to fully understand its safety across different conditions. ^{1 2 6 7 8}

How does the treatment of Music Therapy + Brain Stimulation for Corticobasal Syndrome differ from other treatments?

This treatment is unique because it combines music therapy with brain stimulation to improve motor function in patients with corticobasal syndrome. The use of music therapy, specifically techniques like patterned sensory enhancement and rhythmic auditory stimulation, helps synchronize movements with music, while transcranial direct current stimulation (tDCS) enhances brain activity, making it a novel approach compared to traditional therapies. ^{1 3 4 5 9}

Research Team

Alexander Pantelyat, MD

Principal Investigator

Department of Neurology, Johns Hopkins School of Medicine

Eligibility Criteria

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

I am between 18 and 89 years old.

You are right-handed.

I have CBS.

Exclusion Criteria

I have a history of migraines.

Pregnancy

You have had bad reactions to previous brain stimulation treatments.

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Effects of transcranial direct current stimulation combined with listening to preferred music on memory in older adults. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Preliminary Neurophysiological Evidence of Altered Cortical Activity and Connectivity With Neurologic Music Therapy in Parkinson's Disease. [2021]

4. Finland pubmed.ncbi.nlm.nih.gov

[Effectiveness of music in brain rehabilitation. A systematic review]. [2018]

5. Poland pubmed.ncbi.nlm.nih.gov

Music therapy in neurological rehabilitation settings. [2017]

6. Austria pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Modulation of auditory gamma-band responses using transcranial electrical stimulation. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Shaping pseudoneglect with transcranial cerebellar direct current stimulation and music listening. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Music and Brain Circuitry: Strategies for Strengthening Evidence-Based Research for Music-Based Interventions. [2023]