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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

Tracking Information
First Submitted Date  ICMJE November 27, 2020
First Posted Date  ICMJE December 4, 2020
Last Update Posted Date December 4, 2020
Estimated Study Start Date  ICMJE January 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2020)
Change from baseline to 3-month follow up in verbal fluency task [ Time Frame: Baseline (T0); At 3-month (T3) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2020)
  • 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) ]
  • Change from baseline to 3-month follow up in cognitive symptoms as assessed with cognitive evaluation [ Time Frame: Baseline (T0); At 3-month (T3) ]
  • Change from baseline to 3-month follow up in caregiver distress as assessed with behavioural evaluation [ Time Frame: Baseline (T0); At 3-month (T3) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) in Progressive Supranuclear Palsy (PSP) (STIM-PSP)
Official Title  ICMJE 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 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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Progressive Supranuclear Palsy
  • Motor and Cognitive Symptoms
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Experimental: Real tDCS group
    Partecipants receive anodal tDCS on the left dlPFC for 5 days/week for 2 weeks
    Intervention: Device: Anodal transcranial direct current stimulation (a-tDCS)
  • Sham Comparator: Sham group
    Partecipants receive sham stimulation on the left dlPFC for 5 days/week for 2 weeks
    Intervention: Device: Sham Condition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marina Picillo, MD, PhD 3497725402 ext 39 mpicillo@unisa.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04655079
Other Study ID Numbers  ICMJE tDCS 01-2020
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marina Picillo, University of Salerno
Study Sponsor  ICMJE University of Salerno
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Salerno
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP