Clinical trial NCT05073471: Music and Brain Stimulation for Upper Extremity Performance in Patients With Corticobasal Syndrome
Official title: Patterned Sensory Enhancement (PSE) and Transcranial Direct Current Stimulation (tDCS) for Upper Extremity Performances in Patients With Corticobasal Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Corticobasal Syndrome
Upper Extremity Dysfunction
Keywords: Corticobasal Syndrome (CBS)
Neurologic Music Therapy (NMT)
Patterned Sensory Enhancement (PSE)
Transcranial Direct Current Stimulation (tDCS)
tDCS/EEG
upper extremity performance
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-10-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either PSE or PSE+tDCS group. Following baseline assessment, participants in both groups will receive 30 minutes long, twice a week for 3 weeks. Assessments will be conducted before and after each session. Follow-up assessment will be administrated one month after the last session (6th session).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Corticobasal syndrome (CBS) is a form of atypical Parkinsonian disorder that shares several features with Parkinson's disease (e.g., rigidity, tremor, and difficulties in balance and coordination). However, CBS additionally includes other motor and highly cortical features such as dyspraxia, dystonia, myoclonus, aphasia, sensory loss, and alien limb. Other features including abnormal eye movements, difficulties in objects recognition, and speech changes can also be revealed. The symptoms of CBS often appear in an asymmetric pattern that only shows on one side of the body. Imaging research has found that CBS is associated with brain atrophy in dorsal neocortical regions and basal ganglia. In particular, widespread frontoparietal cortex atrophy is exhibited in CBS. The frontoparietal network is known to orchestrate accurate, rapid, and goal-directed motor behaviors which are crucial performances in the daily life of humans.

Transcranial direct current stimulation (tDCS) is non-invasive neuromodulation that uses direct electrical currents to stimulate specific brain regions. This painless stimulation has been largely developed as a promising tool for depression, stroke, Parkinson's disease as well as other neuropsychological disorders. Specifically, tDCS over the frontoparietal area has enhanced processing speed and consolidation as well as upper extremity performances.

While tDCS has been applied to modulate a variety of cognitive and motor abilities, studies using tDCS in CBS patients are limited. To the best of the investigators' knowledge, two studies have been investigated on how tDCS modulation over the parietal cortex enhances the performance of an ideomotor apraxia test as well as action observation and representation in CBS. These studies provided potentials of using tDCS as a promising tool for linguistic and sensorimotor deficits in patients with CBS. Intriguingly, previous studies have suggested that tDCS combined with rehabilitative training can enhance motor outcomes. Furthermore, there is a need to better understand the mechanisms and effects of tDCS in real time in order to cater treatment protocols in a patient-specific manner. For this purpose, electroencephalography (EEG) has been proposed. EEG which measures brainwaves in milliseconds will be able to measure neurophysiological responses during tDCS modulation as well as rehabilitation intervention, such as music therapy.

Music has been extensively developed as a therapeutic medium to enhance and/or maintain functional skills based on scientific evidence in neurorehabilitation settings. In particular, the use of musical cueing to facilitate motor and cognitive performance has been widely studied. Patterned Sensory Enhancement (PSE) is one of the Neurologic Music Therapy (NMT) interventions to facilitate functional movement patterns and sequences by using tempo, meter, and rhythmic patterns. PSE translates movement patterns into musical patterns to provide spatial, temporal, and force cues. PSE has been employed to improve the functional motor abilities of individuals with stroke, cerebral palsy and Parkinson's disease.

Despite the importance of developing non-invasive but cost-effective interventions for CBS, neuro-rehabilitative effects associated with tDCS/EEG and PSE in this population have been less investigated. Therefore, the present study will investigate the effectiveness of PSE and PSE +tDCS on upper extremity performances in individuals with CBS, and EEG will be used to measure neurophysiological responses during sessions. Non-invasive and patient-oriented interventions may have a broad impact on CBS by improving the quality of functional upper extremity performance.

Eligibility criteria: Inclusion Criteria:

* Patients with CBS
* Age range 18-89
* Right-handed

Exclusion Criteria:

* A history of migraines
* Have a scalp or skin condition (e.g., psoriasis or eczema)
* Have any metallic implants, including intracranial electrodes, surgical clips, shrapnel or a pacemaker
* Have had a head injury resulting in a loss of consciousness that has required further investigation
* Have diagnosed psychological or neurological disorders
* Have had a seizure
* Have had adverse effects to previous tDCS or other brain stimulation techniques (e.g., TMS)
* Pregnancy
* Inability or unwillingness to follow directions for study procedures

Primary outcomes:
measure: Change in functional upper extremity performance score as assessed by the WMFT
timeFrame: Baseline (Day1), Day 24, and Day 52
measure: Change in TOLA score (limb)
timeFrame: Baseline (Day1), Day 24, and Day 52
measure: Change in TOLA score (oral)
timeFrame: Baseline (Day1), Day 24, and Day 52
measure: Change in TOLA score (pictures)
timeFrame: Baseline (Day1), Day 24, and Day 52
measure: Change in TOLA score (command)
timeFrame: Baseline (Day1), Day 24, and Day 52
measure: Change in TOLA score (imitation)
timeFrame: Baseline (Day1), Day 24, and Day 52
measure: Changes in number of pegs placed in 30 seconds
timeFrame: Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52
measure: Change in number of blocks transferred from one compartment to the other compartment in 60 seconds
timeFrame: Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52
Secondary outcomes:
measure: Changes in score on cognitive impairment level as assessed by the MoCA
timeFrame: Baseline (Day 1), Day 24, and Day 52
measure: Change in score on anxiety level as assessed by the STAI
timeFrame: Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52
measure: Change in score on valence as assessed by the SAM
timeFrame: Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52
measure: Change in score on arousal as assessed by the SAM
timeFrame: Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52
measure: Change in score on dominance level as assessed by the SAM
timeFrame: Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52
measure: Change in score on depression level as assessed by the BDI-II
timeFrame: Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52
measure: Change in score on quality of life level as assessed by the CBFS
timeFrame: Baseline (Day 1), Day 24, and Day 52
Other outcomes:
measure: Change in power spectrum density of brainwave spectrum (micro-volts-squared per Hz)
timeFrame: Day 8, Day 10, Day 15, Day 17, Day 22, and Day 24
measure: Change in range of motion (degree) of upper extremity performance
timeFrame: Day 8, Day 10, Day 15, Day 17, Day 22, and Day 24
measure: Change in speed (m/s) of upper extremity performance
timeFrame: Day 8, Day 10, Day 15, Day 17, Day 22, and Day 24
measure: Change in acceleration (m/s^2) of upper extremity performance
timeFrame: Day 8, Day 10, Day 15, Day 17, Day 22, and Day 24
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Department of Neurology, Johns Hopkins School of Medicine
name: Alexander Pantelyat, MD
role: PRINCIPAL_INVESTIGATOR
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