Music and Brain Stimulation for Upper Extremity Performance in Patients With Corticobasal Syndrome

NCT05073471 | Active Not Recruiting

• 1 other identifier: IRB00303400
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (8)

• Change in functional upper extremity performance score as assessed by the WMFT

  Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability examinable through the use of timed and functional tasks. The maximum score is 72, and lower scores are indicative of lower functioning levels.

  Baseline (Day1), Day 24, and Day 52

• Change in TOLA score (limb)

  Test of Oral and Limb Apraxia (TOLA) is designed to identify, measure, and evaluate the presence of oral and limb apraxia in individuals with developmental or acquired neurologic disorders. Each of the TOLA subtests produces several part scores. All subtests are scored by summing the scores on individual items that compose the subtest. Scores all responses in all subtests using 4 point (3,2,1,0) scoring system: 3 = normal; 2 = adequate; 1 = partially adequate; 0 = inadequate. \* Limb Total (Items: 40; Max score: 120)

  Baseline (Day1), Day 24, and Day 52

• Change in TOLA score (oral)

  Test of Oral and Limb Apraxia (TOLA) is designed to identify, measure, and evaluate the presence of oral and limb apraxia in individuals with developmental or acquired neurologic disorders. Each of the TOLA subtests produces several part scores. All subtests are scored by summing the scores on individual items that compose the subtest. Scores all responses in all subtests using 4 point (3,2,1,0) scoring system: 3 = normal; 2 = adequate; 1 = partially adequate; 0 = inadequate. \* Oral Total (Items: 20; Max score: 60)

  Baseline (Day1), Day 24, and Day 52

• Change in TOLA score (pictures)

  Test of Oral and Limb Apraxia (TOLA) is designed to identify, measure, and evaluate the presence of oral and limb apraxia in individuals with developmental or acquired neurologic disorders. Each of the TOLA subtests produces several part scores. All subtests are scored by summing the scores on individual items that compose the subtest. Scores all responses in all subtests using 4 point (3,2,1,0) scoring system: 3 = normal; 2 = adequate; 1 = partially adequate; 0 = inadequate. \* Pictures Total (Items: 15; Max score: 45)

  Baseline (Day1), Day 24, and Day 52

• Change in TOLA score (command)

  Test of Oral and Limb Apraxia (TOLA) is designed to identify, measure, and evaluate the presence of oral and limb apraxia in individuals with developmental or acquired neurologic disorders. Each of the TOLA subtests produces several part scores. All subtests are scored by summing the scores on individual items that compose the subtest. Scores all responses in all subtests using 4 point (3,2,1,0) scoring system: 3 = normal; 2 = adequate; 1 = partially adequate; 0 = inadequate. \* Command Total (Items: 30; Max score: 90)

  Baseline (Day1), Day 24, and Day 52

• Change in TOLA score (imitation)

  Test of Oral and Limb Apraxia (TOLA) is designed to identify, measure, and evaluate the presence of oral and limb apraxia in individuals with developmental or acquired neurologic disorders. Each of the TOLA subtests produces several part scores. All subtests are scored by summing the scores on individual items that compose the subtest. Scores all responses in all subtests using 4 point (3,2,1,0) scoring system: 3 = normal; 2 = adequate; 1 = partially adequate; 0 = inadequate. \* Imitation Total (Items: 30; Max score: 90)

  Baseline (Day1), Day 24, and Day 52

• Changes in number of pegs placed in 30 seconds

  Purdue Pegboard Test (PPBT) involves timed assembly of small items and assesses fine manual dexterity. The total number of pins the subject is scored, and higher scores are indicative of higher fine dexterity level.

  Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52

• Change in number of blocks transferred from one compartment to the other compartment in 60 seconds

  Box and Block Test (BBT) involves timed transfer of 2.5cm 3 blocks from one container to another and assesses the gross manual dexterity. The total number of blocks transferred from one to the other compartment is scored, and higher scores are indicative of a higher gross dexterity level.

  Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52

Secondary Outcomes (7)

• Changes in score on cognitive impairment level as assessed by the MoCA

  Baseline (Day 1), Day 24, and Day 52

• Change in score on anxiety level as assessed by the STAI

  Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52

• Change in score on valence as assessed by the SAM

  Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52

• Change in score on arousal as assessed by the SAM

  Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52

• Change in score on dominance level as assessed by the SAM

  Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52

Other Outcomes (4)

• Change in power spectrum density of brainwave spectrum (micro-volts-squared per Hz)

  Day 8, Day 10, Day 15, Day 17, Day 22, and Day 24

• Change in range of motion (degree) of upper extremity performance

  Day 8, Day 10, Day 15, Day 17, Day 22, and Day 24

• Change in speed (m/s) of upper extremity performance

  Day 8, Day 10, Day 15, Day 17, Day 22, and Day 24

Study Arms (2)

PSE Only

EXPERIMENTAL

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.

Behavioral: Patterned Sensory Enhancement (PSE)

PSE+tDCS

EXPERIMENTAL

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

Behavioral: Patterned Sensory Enhancement (PSE); Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Patterned Sensory Enhancement (PSE) BEHAVIORAL

Patterned Sensory Enhancement (PSE) is one of Neurologic Music Therapy (NMT) techniques. NMT is a research-guided clinical model that is driven by advances in neuroscience and the understanding of the perception, production, and performance of music and how music can influence and change non-musical brain and behavior function. PSE is a technique that uses the rhythmic, melodic, harmonic, and dynamic-acoustical elements of music to provide temporal, spatial, and. force cues for movements which reflect functional movements of activities of daily.

PSE Only; PSE+tDCS

Transcranial Direct Current Stimulation (tDCS) DEVICE

We will apply five small electrodes to participant's head. Once the electrodes are in place, a small electrical current will be passed between the electrodes. Participants will also get "sham" tDCS, which means they will not receive any real stimulation from the electrodes. Most individuals do not find the procedure uncomfortable, and there are no known long-term risks of tDCS. When the current goes through the electrodes, you may feel an itching or tingling sensation under the electrodes or see brief flashes of light, or you may not feel anything at all. If the sensation is unpleasant, participant can report to co-investigator immediately. If participant finds the procedures too uncomfortable, they may stop it at any time. A trained staff member will be present throughout the procedure.

PSE+tDCS

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location

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  BACKGROUND

MeSH Terms

Conditions

Corticobasal Degeneration

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Tauopathies; Neurodegenerative Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Alexander Pantelyat, MD

  Department of Neurology, Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to either PSE or PSE+tDCS group. There will be double blinding for tDCS sessions. The research assistant who administrates tDCS modulation will be blinded to whether participants are receiving active (right or left) or sham tDCS. The participants will also be blinded to whether they receive active (right or left) vs. sham tDCS. Outcomes assessors will also be blinded whether the participant receives active (right or left) or sham tDCS modulation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 11, 2021
• Study Start: April 22, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)