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

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ClinicalTrials.gov Identifier: NCT04655079
Recruitment Status : Not yet recruiting
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Marina Picillo, University of Salerno

Brief Summary:
This is a double-blind, randomized, sham-controlled clinical traial 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).

Condition or disease Intervention/treatment Phase
Progressive Supranuclear Palsy Motor and Cognitive Symptoms Device: Anodal transcranial direct current stimulation (a-tDCS) Device: Sham Condition Not Applicable

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 catodic 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Partecipants will be recruited and randomized in two parallel group: group 1 will receive anodal left dlPFC tDCS (real tDCS) and group 2 will receive sham stimulation for 5 days/week for 2 consecutive weeks, in a 2:1 ratio, respectively. Each partecipant will undergo a clinical evaluation at baseline (T0), immediately after 2 weeks of either real or sham tDCS (T1), at 45-day (T2) and at 3-month follow up (T3) from baseline. PSP phenotypes will be uniformely distributed between treatment arms (ie, =Richardson's syndrome versus non-Richardson's syndrome=1:1).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Randomiziation, monitoring and data management will be performed locally. Randomization will be performed using an online list randomizer (random.org). The study coordinator will generate the random allocation sequence before enrollment. Then, one sub-investigator will perform clinical evaluations and another one will administer the treatment.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) on Motor and Cognitive Symptoms in Progressive Supranuclear Palsy (PSP) (STIM-PSP)
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: Real tDCS group
Partecipants receive anodal tDCS on the left dlPFC for 5 days/week for 2 weeks
Device: Anodal transcranial direct current stimulation (a-tDCS)
tDCS is delivered by a battery-driven constant current stimulator throught a pair of saline soaked surface sponge electrodes. The active electrode (anode) is placed on the scalp over the left dlPFC (F3 according to the 10 to 20 internetional electroencephalogram coordinates) and the cathode is placed over the right deltoid muscle. Durng real stilumation a costant current of 2mA is applied for 20 minutes.
Other Name: Active tDCS

Sham Comparator: Sham group
Partecipants receive sham stimulation on the left dlPFC for 5 days/week for 2 weeks
Device: Sham Condition
For the sham condition the electrode placement is the same of active tDCS but the electric current is ramped down 5 seconds after the beginning of the stimulation.




Primary Outcome Measures :
  1. Change from baseline to 3-month follow up in verbal fluency task [ Time Frame: Baseline (T0); At 3-month (T3) ]

Secondary Outcome Measures :
  1. Change from baseline to 3-month follow in motor symptoms as assessed with sensor recordings (OPAL system) [ Time Frame: Baseline (T0); At 3-month (T3) ]
  2. Change from baseline to 3-month follow up in cognitive symptoms as assessed with cognitive evaluation [ Time Frame: Baseline (T0); At 3-month (T3) ]
  3. Change from baseline to 3-month follow up in caregiver distress as assessed with behavioural evaluation [ Time Frame: Baseline (T0); At 3-month (T3) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 indipendently 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 score <20
  • Left-handedness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655079


Contacts
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Contact: Marina Picillo, MD, PhD 3497725402 ext 39 mpicillo@unisa.it

Locations
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Italy
Centro per le Malattie Neurodegenerative (CEMAND) Dipartimento di Medicina e chirurgia, Sezione Neuroscienze, Università di Salerno
Salerno, Italy
Contact: Marina Picillo, MD, PhD    3497725402 ext 39    mpicillo@unisa.it   
Principal Investigator: Marina Picillo, MD, PhD         
Sponsors and Collaborators
University of Salerno
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Responsible Party: Marina Picillo, MD, PhD, University of Salerno
ClinicalTrials.gov Identifier: NCT04655079    
Other Study ID Numbers: tDCS 01-2020
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marina Picillo, University of Salerno:
Progressive Supranuclear Palsy (PSP)
Transcranial direct current stimulation (tDCS)
Additional relevant MeSH terms:
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Paralysis
Supranuclear Palsy, Progressive
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Ophthalmoplegia
Ocular Motility Disorders
Cranial Nerve Diseases
Tauopathies
Neurodegenerative Diseases
Eye Diseases