Clinical trial NCT04655079: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Progressive Supranuclear Palsy
Motor and Cognitive Symptoms
Keywords: Progressive Supranuclear Palsy (PSP)
Transcranial direct current stimulation (tDCS)
Lead sponsor: University of Salerno
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants 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 participant 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 uniformly distributed between treatment arms (ie, =Richardson's syndrome versus non-Richardson's syndrome=1:1).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline to 3-month follow up in verbal fluency task
timeFrame: Baseline (T0); At 3-month (T3)
Secondary outcomes:
measure: Change from baseline to 3-month follow in motor symptoms as assessed with sensor recordings (OPAL system)
timeFrame: Baseline (T0); At 3-month (T3)
measure: Change from baseline to 3-month follow up in cognitive symptoms as assessed with Montreal Cognitive Assessment (MOCA)
timeFrame: Baseline (T0); At 3-month (T3)
measure: Change from baseline to 3-month follow up in caregiver distress as assessed with Neuropshychiatric Inventory (NPI)
timeFrame: Baseline (T0); At 3-month (T3)
measure: Change from baseline to 3-month follow up in executive function as assessed with Frontal Assessment Battery (FAB)
timeFrame: Baseline (T0); At 3-month (T3)
measure: Change from baseline to 3-month follow up in attention as assessed with Frontal Assessment Battery (FAB)
timeFrame: Baseline (T0); At 3-month (T3)
measure: Change from baseline to 3-month follow up in caregiver distress as assessed with Zarit Carer Burden Burden Interview (ZBI)
timeFrame: Baseline (T0); At 3-month (T3)
Other outcomes:
Locations:
city: Salerno
country: Italy
facility: Centro per le Malattie Neurodegenerative (CEMAND) Dipartimento di Medicina e chirurgia, Sezione Neuroscienze, Università di Salerno
Study officials:
References: