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

Primary Purpose

Progressive Supranuclear Palsy, Motor and Cognitive Symptoms

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Anodal transcranial direct current stimulation (a-tDCS)

Sham Condition

About this trial

This is an interventional treatment trial for Progressive Supranuclear Palsy focused on measuring Progressive Supranuclear Palsy (PSP), Transcranial direct current stimulation (tDCS)

Eligibility Criteria

40 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real tDCS group

Sham group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

fluency in verbal names

Secondary Outcome Measures

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)

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT04655079

First Posted

November 27, 2020

Last Updated

August 1, 2023

Sponsor

University of Salerno

1. Study Identification

Unique Protocol Identification Number

NCT04655079

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2021 (Actual)

Primary Completion Date

May 11, 2022 (Actual)

Study Completion Date

May 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Salerno

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Progressive Supranuclear Palsy, Motor and Cognitive Symptoms

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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).

Masking

ParticipantCare ProviderOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Real tDCS group

Arm Type

Experimental

Arm Description

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

Arm Title

Sham group

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Anodal transcranial direct current stimulation (a-tDCS)

Other Intervention Name(s)

Active tDCS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham Condition

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

fluency in verbal names

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

movements recorded with digital sensors (gait and other tasks)

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

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

Description

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.

Time Frame

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

Title

Change from baseline to 3-month follow up in caregiver distress as assessed with Zarit Carer Burden Burden Interview (ZBI)

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

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

City

Salerno

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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