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

University of Salerno

Status: Completed

Conditions: Motor and Cognitive Symptoms; Progressive Supranuclear Palsy

Treatments: Device: Anodal transcranial direct current stimulation (a-tDCS); Device: Sham Condition

Study type: Interventional

Funder types: Other

Identifiers

NCT04655079

tDCS 01-2020

Details and patient eligibility

About

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).

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 40 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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24 participants in 2 patient groups

Real tDCS group

Experimental group

Description:

Participants receive anodal tDCS on the left dlPFC for 5 days/week for 2 weeks

Treatment:

Device: Anodal transcranial direct current stimulation (a-tDCS)

Sham group

Sham Comparator group

Description:

Participants receive sham stimulation on the left dlPFC for 5 days/week for 2 weeks

Treatment:

Device: Sham Condition