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

NCT04655079 | Completed

• 1 other identifier: tDCS 01-2020
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Progressive Supranuclear Palsy; Motor and Cognitive Symptoms

Keywords

Progressive Supranuclear Palsy (PSP); Transcranial direct current stimulation (tDCS)

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 3-month follow up in verbal fluency task

  fluency in verbal names

  Baseline (T0); At 3-month (T3)

Secondary Outcomes (6)

• Change from baseline to 3-month follow in motor symptoms as assessed with sensor recordings (OPAL system)

  Baseline (T0); At 3-month (T3)

• Change from baseline to 3-month follow up in cognitive symptoms as assessed with Montreal Cognitive Assessment (MOCA)

  Baseline (T0); At 3-month (T3)

• Change from baseline to 3-month follow up in caregiver distress as assessed with Neuropshychiatric Inventory (NPI)

  Baseline (T0); At 3-month (T3)

• Change from baseline to 3-month follow up in executive function as assessed with Frontal Assessment Battery (FAB)

  Baseline (T0); At 3-month (T3)

• Change from baseline to 3-month follow up in attention as assessed with Frontal Assessment Battery (FAB)

  Baseline (T0); At 3-month (T3)

Study Arms (2)

Real tDCS group

EXPERIMENTAL

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

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

Sham group

SHAM COMPARATOR

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

Device: Sham Condition

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.

Also known as: Active tDCS

Real tDCS group

Sham Condition DEVICE

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.

Sham group

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salerno: lead

Study Sites (1)

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

Salerno, Italy

Location

MeSH Terms

Conditions

Supranuclear Palsy, Progressive; Neurobehavioral Manifestations

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Randomization, 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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).

Study Record Dates

• First Submitted: November 27, 2020
• First Posted: December 4, 2020
• Study Start: February 1, 2021
• Primary Completion: May 11, 2022
• Study Completion: May 11, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)