Corticobasal SyndromeNCT05073471

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

A study testing Patterned Sensory Enhancement (PSE) and Transcranial Direct Current Stimulation (tDCS) in people with Corticobasal Syndrome and Upper Extremity Dysfunction, run by Johns Hopkins University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Corticobasal Syndrome, Upper Extremity Dysfunction
What is being tested?: Patterned Sensory Enhancement (PSE) and Transcranial Direct Current Stimulation (tDCS)
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 22 Apr 2022to 30 Jun 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with CBS
Age range 18-89
Right-handed

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins School of Medicine
Baltimore, Maryland, 21205

Other trials in United States

About this study

Official title: Patterned Sensory Enhancement (PSE) and Transcranial Direct Current Stimulation (tDCS) for Upper Extremity Performances in Patients With Corticobasal Syndrome

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.

Read the 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.

Conditions: Corticobasal Syndrome, Upper Extremity Dysfunction
Being tested: Patterned Sensory Enhancement (PSE), Transcranial Direct Current Stimulation (tDCS)
Keywords: Corticobasal Syndrome (CBS), Neurologic Music Therapy (NMT), Patterned Sensory Enhancement (PSE), Transcranial Direct Current Stimulation (tDCS), tDCS/EEG, upper extremity performance
Medical subject headings: Corticobasal Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Patterned Sensory Enhancement (PSE)Behavioural
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.
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.

Study groups in NCT05073471
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Patterned Sensory Enhancement (PSE); Device: Transcranial Direct Current Stimulation (tDCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Montreal Cognitive Assessment (MoCA) is a rapid cognitive screening test that assesses cognitive performance in multiple domains including visuo-spatial and executive functions, naming, memory, attention, language, abstraction, and orientation. Scores on the MoCA range from 0 to 30:
- > 26 = normal
- 18-25 = mild cognitive impairment
- 10-17 = moderate cognitive impairment
- <10 = severe cognitive impairment.
Measured: Baseline (Day 1), Day 24, and Day 52
Change in score on anxiety level as assessed by the STAI
State Trait Anxiety Inventory (STAI) measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. The range of possible scores for the STAI varies from a minimum score of 20 to a maximum score of 80. STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Measured: 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
Self-Assessment Manikin (SAM) is a non-verbal pictorial assessment technique that directly measures the pleasure, arousal, and dominance associated with a person's affective reaction to a wide variety of stimuli.
It uses a series of graphic abstract characters horizontally arranged according to a 5 - points scale.
- Valence rating: 1=unpleasant; 2=unsatisfied; 3=neutral; 4 = pleased; 5=pleasant
Measured: 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
Self-Assessment Manikin (SAM) is a non-verbal pictorial assessment technique that directly measures the pleasure, arousal, and dominance associated with a person's affective reaction to a wide variety of stimuli.
It uses a series of graphic abstract characters horizontally arranged according to a 5 - points scale.
- Arousal rating: 1=calm (sleepy); 2=dull; 3=neutral; 4=wide-awake; 5=excited (energetic)
Measured: 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
Self-Assessment Manikin (SAM) is a non-verbal pictorial assessment technique that directly measures the pleasure, arousal, and dominance associated with a person's affective reaction to a wide variety of stimuli.
It uses a series of graphic abstract characters horizontally arranged according to a 5 - points scale.
- Dominance rating: 1=independent; 2=powerful; 3=neutral; 4=powerlessness; 5=dependent
Measured: Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52
Change in score on depression level as assessed by the BDI-II
Beck-Depression inventory (BDI-II) measures characteristic attitudes and symptoms of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score for the Beck Depression Inventory-II (BDI-II).
There is a four-point scale for each item ranging from 0 to 3. On two items (16 and 18) there are seven options to indicate either an increase or decrease of appetite and sleep. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Measured: Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52
Change in score on quality of life level as assessed by the CBFS
Corticobasal Syndrome Functional Scale (CBFS) is a novel rating scale that evaluates experiences in daily living (EDL), behavioral, language, and cognitive impairments in patients with 4 repeat tauopathies. The CBFS consists of 14 questions on Motor EDL's and 17 questions on Non-Motor EDL's, each of which are rated on a Likert 5 point scale rating function from 0 to 4, where 0 = Normal or No problems and 4 = Severe problems.
Higher scores are indicative of severe problems.
Measured: Baseline (Day 1), Day 24, and Day 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 202230 Jun 2027

First posted11 Oct 2021
Study start22 Apr 2022
Primary completion30 Jun 2027 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Corticobasal SyndromeStudies of the same condition, open and under way.
More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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).
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05073471
Sponsor's protocol ID: IRB00303400
Status last verified: Jun 2026
First submitted: 29 Sep 2021
Last updated: 8 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Armstrong MJ, Litvan I, Lang AE, Bak TH, Bhatia KP, Borroni B, Boxer AL, Dickson DW, Grossman M, Hallett M, Josephs KA, Kertesz A, Lee SE, Miller BL, Reich SG, Riley DE, Tolosa E, Troster AI, Vidailhet M, Weiner WJ. Criteria for the diagnosis of corticobasal degeneration. Neurology. 2013 Jan 29;80(5):496-503. doi: 10.1212/WNL.0b013e31827f0fd1.
PubMed 23359374
Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.
PubMed 20395612
Benninger DH, Lomarev M, Lopez G, Wassermann EM, Li X, Considine E, Hallett M. Transcranial direct current stimulation for the treatment of Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010 Oct;81(10):1105-11. doi: 10.1136/jnnp.2009.202556.
PubMed 20870863
Bianchi M, Cosseddu M, Cotelli M, Manenti R, Brambilla M, Rizzetti MC, Padovani A, Borroni B. Left parietal cortex transcranial direct current stimulation enhances gesture processing in corticobasal syndrome. Eur J Neurol. 2015 Sep;22(9):1317-22. doi: 10.1111/ene.12748. Epub 2015 Jun 13.
PubMed 26073740
Boelmans K, Bodammer NC, Suchorska B, Kaufmann J, Ebersbach G, Heinze HJ, Niehaus L. Diffusion tensor imaging of the corpus callosum differentiates corticobasal syndrome from Parkinson's disease. Parkinsonism Relat Disord. 2010 Sep;16(8):498-502. doi: 10.1016/j.parkreldis.2010.05.006. Epub 2010 Jun 22.
PubMed 20573537
Boeve BF. The multiple phenotypes of corticobasal syndrome and corticobasal degeneration: implications for further study. J Mol Neurosci. 2011 Nov;45(3):350-3. doi: 10.1007/s12031-011-9624-1. Epub 2011 Aug 19.
PubMed 21853287
Broeder S, Nackaerts E, Heremans E, Vervoort G, Meesen R, Verheyden G, Nieuwboer A. Transcranial direct current stimulation in Parkinson's disease: Neurophysiological mechanisms and behavioral effects. Neurosci Biobehav Rev. 2015 Oct;57:105-17. doi: 10.1016/j.neubiorev.2015.08.010. Epub 2015 Aug 20.
PubMed 26297812
Dedoncker J, Brunoni AR, Baeken C, Vanderhasselt MA. A Systematic Review and Meta-Analysis of the Effects of Transcranial Direct Current Stimulation (tDCS) Over the Dorsolateral Prefrontal Cortex in Healthy and Neuropsychiatric Samples: Influence of Stimulation Parameters. Brain Stimul. 2016 Jul-Aug;9(4):501-17. doi: 10.1016/j.brs.2016.04.006. Epub 2016 Apr 12.
PubMed 27160468
Dutt S, Binney RJ, Heuer HW, Luong P, Attygalle S, Bhatt P, Marx GA, Elofson J, Tartaglia MC, Litvan I, McGinnis SM, Dickerson BC, Kornak J, Waltzman D, Voltarelli L, Schuff N, Rabinovici GD, Kramer JH, Jack CR Jr, Miller BL, Rosen HJ, Boxer AL; AL-108-231 investigators. Progression of brain atrophy in PSP and CBS over 6 months and 1 year. Neurology. 2016 Nov 8;87(19):2016-2025. doi: 10.1212/WNL.0000000000003305. Epub 2016 Oct 14.
PubMed 27742814
Kang S, Shin JH, Kim IY, Lee J, Lee JY, Jeong E. Patterns of enhancement in paretic shoulder kinematics after stroke with musical cueing. Sci Rep. 2020 Oct 22;10(1):18109. doi: 10.1038/s41598-020-75143-0.
PubMed 33093633
Loo CK, Alonzo A, Martin D, Mitchell PB, Galvez V, Sachdev P. Transcranial direct current stimulation for depression: 3-week, randomised, sham-controlled trial. Br J Psychiatry. 2012 Jan;200(1):52-9. doi: 10.1192/bjp.bp.111.097634.
PubMed 22215866
Manenti R, Bianchi M, Cosseddu M, Brambilla M, Rizzetti C, Padovani A, Borroni B, Cotelli M. Anodal transcranial direct current stimulation of parietal cortex enhances action naming in Corticobasal Syndrome. Front Aging Neurosci. 2015 Apr 14;7:49. doi: 10.3389/fnagi.2015.00049. eCollection 2015.
PubMed 25926792
Marek S, Dosenbach NUF. The frontoparietal network: function, electrophysiology, and importance of individual precision mapping. Dialogues Clin Neurosci. 2018 Jun;20(2):133-140. doi: 10.31887/DCNS.2018.20.2/smarek.
PubMed 30250390
McClintock SM, Martin DM, Lisanby SH, Alonzo A, McDonald WM, Aaronson ST, Husain MM, O'Reardon JP, Weickert CS, Mohan A, Loo CK. Neurocognitive effects of transcranial direct current stimulation (tDCS) in unipolar and bipolar depression: Findings from an international randomized controlled trial. Depress Anxiety. 2020 Mar;37(3):261-272. doi: 10.1002/da.22988. Epub 2020 Jan 16.
PubMed 31944487
Meron D, Hedger N, Garner M, Baldwin DS. Transcranial direct current stimulation (tDCS) in the treatment of depression: Systematic review and meta-analysis of efficacy and tolerability. Neurosci Biobehav Rev. 2015 Oct;57:46-62. doi: 10.1016/j.neubiorev.2015.07.012. Epub 2015 Jul 29.
PubMed 26232699

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patterned Sensory Enhancement (PSE) and Transcranial Direct Current Stimulation (tDCS) for Upper Extremity Performances in Patients With Corticobasal Syndrome
ClinicalTrials.gov ID: NCT05073471
Acronym / sponsor ID: IRB00303400
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
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 20 participants (estimated)
Lead sponsor: Johns Hopkins UniversityUniversity, hospital or other
Study start: 22 Apr 2022 (actual)
Primary completion: 30 Jun 2027 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 11 Oct 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
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).

Arm	Type	Receives
PSE Only	Experimental	Behavioral: Patterned Sensory Enhancement (PSE)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.
PSE+tDCS	Experimental	Behavioral: Patterned Sensory Enhancement (PSE), Device: Transcranial Direct Current Stimulation (tDCS)Participants in this group will proceed with the same procedure as PSE only group, but tDCS modulation will be additionally provided.

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients with CBS
Age range 18-89
Right-handed

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Patterned Sensory Enhancement (PSE)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.	Behavioural	PSE Only, PSE+tDCS
Transcranial Direct Current Stimulation (tDCS)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.	Device	PSE+tDCS

Primary outcome

Change in functional upper extremity performance score as assessed by the WMFT
Time frame: Baseline (Day1), Day 24, and Day 52
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.
Change in TOLA score (limb)
Time frame: Baseline (Day1), Day 24, and Day 52
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)
Change in TOLA score (oral)
Time frame: Baseline (Day1), Day 24, and Day 52
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)
Change in TOLA score (pictures)
Time frame: Baseline (Day1), Day 24, and Day 52
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)
Change in TOLA score (command)
Time frame: Baseline (Day1), Day 24, and Day 52
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)
Change in TOLA score (imitation)
Time frame: Baseline (Day1), Day 24, and Day 52
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)
Changes in number of pegs placed in 30 seconds
Time frame: Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52
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.
Change in number of blocks transferred from one compartment to the other compartment in 60 seconds
Time frame: Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52
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.

7 secondary outcomes

Changes in score on cognitive impairment level as assessed by the MoCA
Time frame: Baseline (Day 1), Day 24, and Day 52
Change in score on anxiety level as assessed by the STAI
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52
Change in score on depression level as assessed by the BDI-II
Time frame: Baseline (Day 1), Day 8, Day 10, Day 15, Day 17, Day 22, Day 24, and Day 52
Change in score on quality of life level as assessed by the CBFS
Time frame: Baseline (Day 1), Day 24, and Day 52

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
Background: PubMed 23359374Armstrong MJ, Litvan I, Lang AE, Bak TH, Bhatia KP, Borroni B, Boxer AL, Dickson DW, Grossman M, Hallett M, Josephs KA, Kertesz A, Lee SE, Miller BL, Reich SG, Riley DE, Tolosa E, Troster AI, Vidailhet M, Weiner WJ. Criteria for the diagnosis of corticobasal degeneration. Neurology. 2013 Jan 29;80(5):496-503. doi: 10.1212/WNL.0b013e31827f0fd1.
Background: PubMed 20395612Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15.
Background: PubMed 20870863Benninger DH, Lomarev M, Lopez G, Wassermann EM, Li X, Considine E, Hallett M. Transcranial direct current stimulation for the treatment of Parkinson's disease. J Neurol Neurosurg Psychiatry. 2010 Oct;81(10):1105-11. doi: 10.1136/jnnp.2009.202556.
Background: PubMed 26073740Bianchi M, Cosseddu M, Cotelli M, Manenti R, Brambilla M, Rizzetti MC, Padovani A, Borroni B. Left parietal cortex transcranial direct current stimulation enhances gesture processing in corticobasal syndrome. Eur J Neurol. 2015 Sep;22(9):1317-22. doi: 10.1111/ene.12748. Epub 2015 Jun 13.
Background: PubMed 20573537Boelmans K, Bodammer NC, Suchorska B, Kaufmann J, Ebersbach G, Heinze HJ, Niehaus L. Diffusion tensor imaging of the corpus callosum differentiates corticobasal syndrome from Parkinson's disease. Parkinsonism Relat Disord. 2010 Sep;16(8):498-502. doi: 10.1016/j.parkreldis.2010.05.006. Epub 2010 Jun 22.
Background: PubMed 21853287Boeve BF. The multiple phenotypes of corticobasal syndrome and corticobasal degeneration: implications for further study. J Mol Neurosci. 2011 Nov;45(3):350-3. doi: 10.1007/s12031-011-9624-1. Epub 2011 Aug 19.
Background: PubMed 26297812Broeder S, Nackaerts E, Heremans E, Vervoort G, Meesen R, Verheyden G, Nieuwboer A. Transcranial direct current stimulation in Parkinson's disease: Neurophysiological mechanisms and behavioral effects. Neurosci Biobehav Rev. 2015 Oct;57:105-17. doi: 10.1016/j.neubiorev.2015.08.010. Epub 2015 Aug 20.
Background: PubMed 27160468Dedoncker J, Brunoni AR, Baeken C, Vanderhasselt MA. A Systematic Review and Meta-Analysis of the Effects of Transcranial Direct Current Stimulation (tDCS) Over the Dorsolateral Prefrontal Cortex in Healthy and Neuropsychiatric Samples: Influence of Stimulation Parameters. Brain Stimul. 2016 Jul-Aug;9(4):501-17. doi: 10.1016/j.brs.2016.04.006. Epub 2016 Apr 12.
Background: PubMed 27742814Dutt S, Binney RJ, Heuer HW, Luong P, Attygalle S, Bhatt P, Marx GA, Elofson J, Tartaglia MC, Litvan I, McGinnis SM, Dickerson BC, Kornak J, Waltzman D, Voltarelli L, Schuff N, Rabinovici GD, Kramer JH, Jack CR Jr, Miller BL, Rosen HJ, Boxer AL; AL-108-231 investigators. Progression of brain atrophy in PSP and CBS over 6 months and 1 year. Neurology. 2016 Nov 8;87(19):2016-2025. doi: 10.1212/WNL.0000000000003305. Epub 2016 Oct 14.
Background: PubMed 33093633Kang S, Shin JH, Kim IY, Lee J, Lee JY, Jeong E. Patterns of enhancement in paretic shoulder kinematics after stroke with musical cueing. Sci Rep. 2020 Oct 22;10(1):18109. doi: 10.1038/s41598-020-75143-0.
Background: PubMed 22215866Loo CK, Alonzo A, Martin D, Mitchell PB, Galvez V, Sachdev P. Transcranial direct current stimulation for depression: 3-week, randomised, sham-controlled trial. Br J Psychiatry. 2012 Jan;200(1):52-9. doi: 10.1192/bjp.bp.111.097634.
Background: PubMed 25926792Manenti R, Bianchi M, Cosseddu M, Brambilla M, Rizzetti C, Padovani A, Borroni B, Cotelli M. Anodal transcranial direct current stimulation of parietal cortex enhances action naming in Corticobasal Syndrome. Front Aging Neurosci. 2015 Apr 14;7:49. doi: 10.3389/fnagi.2015.00049. eCollection 2015.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alexander Pantelyat, MD principal investigator

Department of Neurology, Johns Hopkins School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in functional upper extremity performance score as assessed by the WMFT (time frame: Baseline (Day1), Day 24, and Day 52). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05073471, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.