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

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

Tracking Information

• First Submitted Date: November 27, 2020
• First Posted Date: December 4, 2020
• Last Update Posted Date: December 4, 2020
• Estimated Study Start Date: January 2021
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 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: Interventional
• Study Phase: Not Applicable

Study Design

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

• Progressive Supranuclear Palsy
• Motor and Cognitive Symptoms

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: November 27, 2020): 24
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2021
• Estimated Primary Completion Date: June 2021 (Final data collection date for primary outcome measure)

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 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

• Sexes Eligible for Study: All

• Ages: 40 Years to 89 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Italy

Administrative Information

• NCT Number: NCT04655079
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Marina Picillo, University of Salerno
• Study Sponsor: University of Salerno
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Salerno
• Verification Date: November 2020