Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) in Progressive Supranuclear Palsy (PSP) (STIM-PSP)

Related Clinical Trial
Tau Protein and SV2a Imaging in Patients With Tau Protein-related Diseases Building Online Community for Parkinson’s Palliative Care Test-retest Study With [18F]PI-2620 in PSP-RS and NDC Evaluation of the Efficacy of a Two-week EMST on Dysphagia in Parkinsonian Patients Optimization of Morphomer-based Alpha-synuclein PET Tracers Evaluation of [18F]APN-1607 as a PET Biomarker A Phase 2a Study of TPN-101 in Patients With Progressive Supranuclear Palsy (PSP) RT001 in Patients With Progressive Supranuclear Palsy (PSP) PROGRESSIVE SUPRANUCLEAR PALSY Complex Eye Movements in Parkinson’s Disease and Related Movement Disorders tDCS and Speech Therapy for Motor Speech Disorders Caused by FTLD Syndromes: a Feasibility Study Application od Machine Learning Method in Validation of Screening Cognitive Test for Parkinsonisms Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA) Remote Monitoring in Progressive Supranuclear Palsy (PSP) Trial of Parkinson’s And Zoledronic Acid Rho Kinase (ROCK) Inhibitor in Tauopathies – 1 UPenn Observational Research Repository on Neurodegenerative Disease Evaluation of Imaging Characteristics of [18F]PI-2620 PET in AD and PSP Patients Using High and Low Specific Activity Systematic Assessment of Laryngopharyngeal Function in Patients With MSA, PD, and 4repeat Tauopathies The MOTIVE-PSP Initiative A Study to Test the Safety and Tolerability of Long-term UCB0107 Administration in Study Participants With Progressive Supranuclear Palsy Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) in Progressive Supranuclear Palsy (PSP) (STIM-PSP) Image Characteristic and Longitudinal Follow up of 18F-PMPBB3 (APN-1607) PET for Progressive Supranuclear Palsy Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of NIO752 in Progressive Supranuclear Palsy Misfolded Proteins in the Skin of People With Parkinson’s Disease and Other Parkinsonism Neurodegenerative Diseases Registry Transcranial Magnetic Stimulation in Progressive Supranuclear Palsy 18F-PM-PBB3 PET Study in Tauopathy Including Alzheimer’s Disease, Other Dementias and Normal Controls Brain Network Activation in Patients With Movement Disorders Neurologic Stem Cell Treatment Study ARTFL LEFFTDS Longitudinal Frontotemporal Lobar Degeneration (ALLFTD) Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes ADDIA Proof-of-Performance Clinical Study Defining Phenotypes of Movement Disorders :Parkinson’s Plus Disorders (PD), Essential Tremor (ET), Cortical Basal Degeneration (CBD), Multiple Systems Atrophy (MSA), Magnetoencephalography. Gait Analysis in Neurological Disease Diagnosing Frontotemporal Lobar Degeneration Evaluation of [18F]MNI-815 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Tauopathies Study of the Neural Basis of Analogical Reasoning Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia Phase 1 Test-retest Evaluation of [18F]MNI-958 PET Diagnostic and Prognostic Biomarkers in Parkinson Disease Tau Imaging With JNJ067 Research of Biomarkers in Parkinson Disease More Than a Movement Disorder: Applying Palliative Care to Parkinson’s Disease Safety and Efficacy of Droxidopa for Fatigue in Patients With Parkinsonism Identifying Biomarkers of Parkinson’s Disease Using Magnetic Resonance Imaging (MRI) Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL) Davunetide (AL-108) in Predicted Tauopathies – Pilot Study Robot Walking Rehabilitation in Parkinson’s Disease Human CNS Tau Kinetics in Tauopathies 4-Repeat Tauopathy Neuroimaging Initiative – Cycle 2 In-Home Care for Patients With PSP and Related Disorders Facilitating Diagnostics and Prognostics of Parkinsonian Syndromes Using Neuroimaging Study of NBMI Treatment in Patients With Atypical Parkinsons (PSP or MSA) Biomarkers in Parkinsonian Syndromes Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the Brain Effects of Coenzyme Q10 in PSP and CBD 2-(1-{6-[(2-[F-18]Fluoroethyl) (Methyl)Amino]-2-naphthyl} Ethylidene) Malononitrile-PET for in Vivo Diagnose of Tauopathy in Unclassified Parkinsonism Oxford Study of Quantification in Parkinsonism A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese Patients Evaluation of [18F]MNI-777 PET as a Marker of Tau Pathology in Subjects With Tauopathies Compared to Healthy Subjects The Neural Basis for Frontotemporal Degeneration Analysis of the Enteric Nervous System Using Colonic Biopsies Evaluation of Tolfenamic Acid in Individuals With PSP at 12-Weeks Chromatic Pupillometry to Assess the Melanopsin-Light Pathway in Progressive Supranuclear Palsy 4 Repeat Tauopathy Neuroimaging Initiative A Study to Assess Tolerability, Safety, Pharmacokinetics and Effect of AZP2006 in Patients With PSP Foot Mechanical Stimulation for Treatment of Gait and Gait Related Disorders in Parkinson’s Disease and Progressive Supranuclear Palsy. Safety Study of TPI-287 to Treat CBS and PSP Phase 0 Evaluation of [18F]MNI-958 as a Potential PET Radioligand for Imaging Tau Protein in the Brain Neuroprotection and Natural History in Parkinson’s Plus Syndromes (NNIPPS) Efficacy Study for Treatment of Dementia in Progressive Supranuclear Palsy A 6 Month, Open-Label, Pilot Futility Clinical Trial of Oral Salsalate for Progressive Supranuclear Palsy Pathophysiology of Gait and Posture in Progressive Supranuclear Palsy A Pilot Clinical Trial of Pyruvate, Creatine, and Niacinamide in Progressive Supranuclear Palsy. Clinical Trial to Evaluate Bone Marrow Stem Cell Therapy for PSP, a Rare Form of Parkinsonism tDCS Plus Physical Therapy for Progressive Supranuclear Palsy Repetitive Transcranial Magnetic Stimulation (TMS) for Progressive Supranuclear Palsy and Corticobasal Degeneration Risk Factors for Progressive Supranuclear Palsy (PSP) Continuously Infused Recombinant-Methionyl Human Glial Cell Line-Derived Neurotrophic Factor (GDNF) to Treat Progressive Supranuclear Palsy Cerebellar rTMS Theta Burst for Postural Instability in Progressive Supranuclear Palsy Neuropsychological Evaluation for Early Diagnosis of PSP Evaluating Cerebrospinal Fluid Biomarkers in Alzheimer’s, Progressive Supranuclear Palsy Subjects, and Controls A Pilot Trial of Lithium in Subjects With Progressive Supranuclear Palsy or Corticobasal Degeneration Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104 Study About Safety and Efficacy of Coenzyme Q10 in Progressive Supranuclear Palsy Study of the Distractibility Syndrome in Patients With Progressive Supranuclear Palsy Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers Extension Study of BIIB092 in Participants With Progressive Supranuclear Palsy (PSP) Who Participated in CN002003 PROgressive Supranuclear Palsy CorTico-Basal Syndrome Multiple System Atrophy Longitudinal Study UK The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear Palsy Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy Young Plasma Transfusions for Progressive Supranuclear Palsy Study of BIIB092 in Participants With Progressive Supranuclear Palsy A Study to Test the Safety and Tolerability of UCB0107 in Study Participants With Progressive Supranuclear Palsy (PSP) Safety, Tolerability, and Pharmacokinetics of C2N-8E12 in Subjects With Progressive Supranuclear Palsy Deep TMS for the Treatment of Patients With Parkinson’s Disease and Progressive Supranuclear Palsy Rehabilitation in Patients With Progressive Supranuclear Palsy A Molecular Anatomic Imaging Analysis of Tau in Progressive Supranuclear Palsy Alpha-lipoic Acid/L-acetyl Carnitine for Progressive Supranuclear Palsy Multiple Ascending Dose Study of Intravenously Administered BMS-986168 (BIIB092) in Patients With Progressive Supranuclear Palsy Effects of Coenzyme Q10 in Progressive Supranuclear Palsy (PSP) Quality of Life of the Patient and the Burden of the Caregiver in Progressive Supranuclear Palsy An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP) A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP). Trial of Valproic Acid in Patients With Progressive Supranuclear Palsy (Depakine) Safety, Tolerability, and Efficacy of Two Different Oral Doses of NP031112 Versus Placebo in the Treatment of Patients With Mild-to-Moderate Progressive Supranuclear Palsy Efficacy, Tolerability and Safety of Azilect in Subjects With Progressive Supranuclear Palsy Postural Instability in Progressive Supranuclear Palsy

Brief Title

Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) in Progressive Supranuclear Palsy (PSP) (STIM-PSP)

Official Title

Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) on Motor and Cognitive Symptoms in Progressive Supranuclear Palsy (PSP) (STIM-PSP)

Brief Summary

      This is a double-blind, randomized, sham-controlled clinical trial that aim to verify the
      safety and the efficacy of anodal transcranial direct current stimulation (tDCS) on cognitive
      and motor symptoms in Progressive Supranuclear Palsy (PSP) over the left dorsolateral
      prefrontal cortex (dlPFC).
    

Detailed Description

      Progressive Supranuclear Palsy (PSP) is a rapidly progressive neurodegenerative disease
      characterized by deposition of tau and motor, cognitive and behavioral symptoms. Since no
      effective treatment is available, non-invasive brain stimulation techniques, such as tDCS,
      could be a valid complementary therapeutic approach. The tDCS modulates the spontaneous
      activity of the neural network by applying a direct current flow on the cortical brain areas
      (anodic or cathodic stimulation). Despite its efficacy in psychiatric disorders, the
      therapeutic use of tDCS in neurodegenerative diseases requires more systematic studies. The
      aim of this study is to verify the safety and efficacy of tDCS in PSP on motor, cognitive and
      behavioral symptoms.
    


Study Type

Interventional


Primary Outcome

Change from baseline to 3-month follow up in verbal fluency task

Secondary Outcome

 Change from baseline to 3-month follow in motor symptoms as assessed with sensor recordings (OPAL system)

Condition

Progressive Supranuclear Palsy

Intervention

Anodal transcranial direct current stimulation (a-tDCS)

Study Arms / Comparison Groups

 Real tDCS group
Description:  Participants receive anodal tDCS on the left dlPFC for 5 days/week for 2 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

24

Start Date

February 1, 2021

Completion Date

August 2022

Primary Completion Date

August 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Diagnosis of PSP according with Movement Disorder Society (MDS) criteria (Hoglinger et
             al., 2017);

          -  Age > 40 and < 89 years;

          -  Presence of a caregiver supportive the patient for all study procedure;

          -  Ability to walk for at least 5 steps either independently or with a minimum support
             (another patients holding patient's arm or with a walker)

        Exclusion Criteria:

          -  Presence of electrical stimulators (for example, pacemaker, Deep Brain Stimulation,
             DBS)

          -  Difficult in understanding Italian language

          -  Presence of severe sensory deficits (for example, visual or hearing impairments)

          -  Education level <5 years

          -  History of drug abuse

          -  History of severe psychiatric disorders

          -  History of transient ischemic attacks

          -  Cortical or sub-cortical vascular lesions

          -  Seizures or severe heart problems and previous neurosurgical operations

          -  Absence of subjective cognitive deficits

          -  MMSE (Mini-Mental State Examination) score <20

          -  Left-handedness
      

Gender

All

Ages

40 Years - 89 Years

Accepts Healthy Volunteers

No

Contacts

, 3497725402, [email protected]

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT04655079

Organization ID

tDCS 01-2020


Responsible Party

Principal Investigator

Study Sponsor

University of Salerno


Study Sponsor

, , 


Verification Date

January 2022