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

Progressive Supranuclear Palsy Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04655079
• Other study ID #: tDCS 01-2020
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: May 11, 2022

Study information

• Verified date: August 2023
• Source: University of Salerno
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 11, 2022
• Est. primary completion date: May 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Motor and Cognitive Symptoms
• Neurobehavioral Manifestations
• Paralysis
• Progressive Supranuclear Palsy
• Supranuclear Palsy, Progressive

Intervention

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

Locations

Country	Name	City	State
Italy	Centro per le Malattie Neurodegenerative (CEMAND) Dipartimento di Medicina e chirurgia, Sezione Neuroscienze, Università di Salerno	Salerno

Sponsors (1)

Lead Sponsor	Collaborator
University of Salerno

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to 3-month follow up in verbal fluency task	fluency in verbal names	Baseline (T0); At 3-month (T3)
Secondary	Change from baseline to 3-month follow in motor symptoms as assessed with sensor recordings (OPAL system)	movements recorded with digital sensors (gait and other tasks)	Baseline (T0); At 3-month (T3)
Secondary	Change from baseline to 3-month follow up in cognitive symptoms as assessed with Montreal Cognitive Assessment (MOCA)	Cognitive status assessed with Montreal Cognitive Assessment (MOCA). The cut off is 15,5. The minimum value is 0 and the maximum is 30. Higher scores mean a better outcome.	Baseline (T0); At 3-month (T3)
Secondary	Change from baseline to 3-month follow up in caregiver distress as assessed with Neuropshychiatric Inventory (NPI)	depression symptoms, apathy, neuropsychiatric symptoms assessed with Neuropshychiatric Inventory (NPI) . The minimum value of distress is 0 and the maximum is 5. Higher scores mean a worse outcome.	Baseline (T0); At 3-month (T3)
Secondary	Change from baseline to 3-month follow up in executive function as assessed with Frontal Assessment Battery (FAB)	Executive function assessed with Frontal Assessment Battery (FAB). The cut off is 13,4. The minimum value is 0 and the maximum is 18. Higher scores mean a better outcome.	Baseline (T0); At 3-month (T3)
Secondary	Change from baseline to 3-month follow up in attention as assessed with Frontal Assessment Battery (FAB)	Attention assessed with Frontal Assessment Battery (FAB). The cut off is 13,4. The minimum value is 0 and the maximum is 18. Higher scores mean a better outcome.	Baseline (T0); At 3-month (T3)
Secondary	Change from baseline to 3-month follow up in caregiver distress as assessed with Zarit Carer Burden Burden Interview (ZBI)	Caregiver distress assessed with Zarit Carer Burden Burden Interview (ZBI). The minimum value is 0 and the maximum is 88. The cut off is 46. Higher scores mean a worse outcome.	Baseline (T0); At 3-month (T3)