## Protocol Section
### Identification Module
**NCT ID:** NCT04655079

**Acronym:** STIM-PSP

**Brief Title:** Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) in Progressive Supranuclear Palsy (PSP) (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)

#### Organization Study ID Info
**ID:** tDCS 01-2020
#### Organization
**Class:** OTHER
**Full Name:** University of Salerno
### Status Module
#### Completion Date
**Date:** 2022-05-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-08-02

**Type:** ACTUAL

**Last Update Submit Date:** 2023-08-01

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-05-11

**Type:** ACTUAL

#### Start Date
**Date:** 2021-02-01

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2020-12-04
**Type:** ACTUAL
**Study First Submit Date:** 2020-11-27
**Study First Submit QC Date:** 2020-11-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Salerno

#### Responsible Party

**Investigator Affiliation:** University of Salerno

**Investigator Full Name:** Marina Picillo

**Investigator Title:** Clinical Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Progressive Supranuclear Palsy

- Motor and Cognitive Symptoms

**Keywords:**

- Progressive Supranuclear Palsy (PSP)

- Transcranial direct current stimulation (tDCS)

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention 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 Info

**Masking:** TRIPLE

**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.

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 24

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

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

**Label:** Real tDCS group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Device: Sham Condition

**Label:** Sham group

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Real tDCS group

**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.

**Name:** Anodal transcranial direct current stimulation (a-tDCS)

**Other Names:**

- Active tDCS

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Sham group

**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.

**Name:** Sham Condition

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** fluency in verbal names

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

**Time Frame:** Baseline (T0); At 3-month (T3)

#### Secondary Outcomes

**Description:** movements recorded with digital sensors (gait and other tasks)

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

**Time Frame:** Baseline (T0); At 3-month (T3)

**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.

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

**Time Frame:** Baseline (T0); At 3-month (T3)

**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.

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

**Time Frame:** Baseline (T0); At 3-month (T3)

**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.

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

**Time Frame:** Baseline (T0); At 3-month (T3)

**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.

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

**Time Frame:** Baseline (T0); At 3-month (T3)

**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.

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

**Time Frame:** Baseline (T0); At 3-month (T3)

### Eligibility Module

**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

**Maximum Age:** 89 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Salerno

**Country:** Italy

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

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000001480

- Term: Basal Ganglia Diseases

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009069

- Term: Movement Disorders

- ID: D000009886

- Term: Ophthalmoplegia

- ID: D000015835

- Term: Ocular Motility Disorders

- ID: D000003389

- Term: Cranial Nerve Diseases

- ID: D000024801

- Term: Tauopathies

- ID: D000019636

- Term: Neurodegenerative Diseases

- ID: D000005128

- Term: Eye Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC11

- Name: Eye Diseases

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13157

- Name: Paralysis

- Relevance: HIGH

- As Found: Palsy

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: HIGH

- As Found: Cognitive Symptoms

- ID: M16275

- Name: Supranuclear Palsy, Progressive

- Relevance: HIGH

- As Found: Progressive Supranuclear Palsy

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M25603

- Name: Ganglion Cysts

- Relevance: LOW

- As Found: Unknown

- ID: M16358

- Name: Synovial Cyst

- Relevance: LOW

- As Found: Unknown

- ID: M4774

- Name: Basal Ganglia Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12029

- Name: Movement Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12817

- Name: Ophthalmoplegia

- Relevance: LOW

- As Found: Unknown

- ID: M18386

- Name: Ocular Motility Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M6605

- Name: Cranial Nerve Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23002

- Name: Tauopathies

- Relevance: LOW

- As Found: Unknown

- ID: M21558

- Name: Neurodegenerative Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8271

- Name: Eye Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4741

- Name: Progressive Supranuclear Palsy

- Relevance: HIGH

- As Found: Progressive Supranuclear Palsy

### Condition Browse Module - Meshes

- ID: D000010243

- Term: Paralysis

- ID: D000013494

- Term: Supranuclear Palsy, Progressive

- ID: D000019954

- Term: Neurobehavioral Manifestations

### Misc Info Module

- Version Holder: 2024-05-24
