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

University of Salerno24 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Progressive Supranuclear Palsy Motor and Cognitive Symptoms

Interventions

Anodal transcranial direct current stimulation (a-tDCS)DEVICE

tDCS is delivered by a battery-driven constant current stimulator thought 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 international electroencephalogram coordinates) and the cathode is placed over the right deltoid muscle. During real stimulation a constant current of 2mA (milli Ampere) is applied for 20 minutes.

Sham ConditionDEVICE

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

Centro per le Malattie Neurodegenerative (CEMAND) Dipartimento di Medicina e chirurgia, Sezione Neuroscienze, Università di Salerno

Salerno, Italy