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

Not Applicable

Completed

• Conditions: Progressive Supranuclear Palsy; Motor and Cognitive Symptoms
• Interventions: Device: Sham Condition; Device: Anodal transcranial direct current stimulation (a-tDCS)

• Registration Number: NCT04655079
• Lead Sponsor: University of Salerno

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.

Study Timeline

• Study First Submitted: 2020-11-27
• Study First Submitted QC: 2020-11-27
• Study First Posted: 2020-12-04
• Study Start: 2021-02-01
• Primary Completion: 2022-05-11
• Study Completion: 2022-05-11
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-01
• Last Update Posted: 2023-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham group	Sham Condition	Participants receive sham stimulation on the left dlPFC for 5 days/week for 2 weeks
Real tDCS group	Anodal transcranial direct current stimulation (a-tDCS)	Participants receive anodal tDCS on the left dlPFC for 5 days/week for 2 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline to 3-month follow up in verbal fluency task	Baseline (T0); At 3-month (T3)	fluency in verbal names

Secondary Outcome Measures

Name	Time	Method
Change from baseline to 3-month follow up in attention as assessed with Frontal Assessment Battery (FAB)	Baseline (T0); At 3-month (T3)	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.
Change from baseline to 3-month follow up in caregiver distress as assessed with Zarit Carer Burden Burden Interview (ZBI)	Baseline (T0); At 3-month (T3)	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.
Change from baseline to 3-month follow up in cognitive symptoms as assessed with Montreal Cognitive Assessment (MOCA)	Baseline (T0); At 3-month (T3)	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.
Change from baseline to 3-month follow up in caregiver distress as assessed with Neuropshychiatric Inventory (NPI)	Baseline (T0); At 3-month (T3)	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.
Change from baseline to 3-month follow up in executive function as assessed with Frontal Assessment Battery (FAB)	Baseline (T0); At 3-month (T3)	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.
Change from baseline to 3-month follow in motor symptoms as assessed with sensor recordings (OPAL system)	Baseline (T0); At 3-month (T3)	movements recorded with digital sensors (gait and other tasks)

Trial Locations

Locations (1)

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