Efficacy and Safety of Transcranial dIrect Current stiMulation in Multiple System Atrophy-Cerebellar Variant (STIM-MSA)

April 28, 2026 updated by: Roberto Erro, University of Salerno

Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) on Cerebellar Symptoms in Multiple System Atrophy-Cerebellar Variant (MSA-C) (STIM-MSA)

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) cerebellar symptoms in Multiple System Atrophy type C (MSA).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Multiple system atrophy (MSA) is a progressive neurodegenerative disease for which, to date, no causal therapy is available, symptomatic treatment therefore playing a pivotal role in patient care (Fanciulli & Wenning, 2015). Unfortunately, there are very limited effective symptomatic treatments, especially for the cerebellar variant of MSA (MSA-C) which calls for the urgent need of developing alternative strategies to improve patients' disability and quality of life (QoL). An emergent approach to cerebellar disorders of various etiologies stands in the use of non-invasive brain stimulation (NIBS) techniques (Erro R et al., 2017), namely in the use of trans-cranial direct current stimulation (tDCS), to modulates neuronal excitability in a polarity-specific manner by delivering prolonged (up to 20-30 min) but weak (1-2 mA) currents to brain tissues via electrodes placed on the scalp (Stagg & Nitsche, 2011).

This project has been designed as a double-blinded, sham-controlled, cross-over trial with two independent arms to assess the feasibility and compare the efficacy of two different tDCS protocols. Sample size calculation has been calculated on preliminary unpublished results of our own research using tDCS in other atypical parkinsonisms (i.e., PSP) and we will accordingly recruit 15 patients for each arm of the study. Patients will be randomly assigned to one of the two arms and all will receive a sham-stimulation for 5 consecutive days/week (i.e.,Monday to Friday) and an active stimulation for 5 consecutive days/week (i.e., Monday to Friday). The order of the sham- vs active-stimulation will be also randomized within each arm. The active stimulation will consist of an anodal stimulation over the cerebellum area (2 cm under the inion, using a 7 × 5 cm sponge electrode), with the cathode being applied either to the right deltoid muscle (arm 1: cerebellar stimulation) or over the spinal lumbar enlargement (2 cm under T11; arm 2: cerebellar-spinal stimulation) using a sponge electrode of the same size as the anode. During anodal stimulation, a constant current of 2 mA will be applied for 20 minutes, as suggested by recently published consensus recommendations (Grimaldi et al, 2014). For the sham condition, the electrode placement will be the same as for the active stimulation, but the electric current will be ramped down 5 seconds after the beginning of the stimulation to make this condition indistinguishable from the experimental stimulation.

Before (T0), soon after the first week of the protocol (T1) and soon after the second week of the protocol (T2) all patients will be evaluated using 1) validated clinical scales for cerebellar disorders (SARA, ICARS) and 2) through the 8-m walking test (8MW); defined as the time needed to walk 8 m as quickly as possible but safely with any device but without the help of another person or wall. During the 8MW wearable sensors (OPAL) will be further used to collect objective measures of gait and balance. Finally, PROs will be collected by means of 1) the clinical global improvement measure (CGI-I) ranging from 1 (very much improved) to 7 (very much worse), with patients being asked to report their perceived improvement at T1 and T2; and 2) by two instruments for depicting change in QoL, namely the EuroQoL-5Dimensions, 3Levels (EQ-5D-3L) and the MSA-QoL (Schrag, Mov Disord 2007), both of which will be performed at T0, T1 and T2. Patients will be further asked whether they thought they were receiving real or sham stimulation at the end of the 2-week treatment.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Roberto Erro MD, PhD
  • Phone Number: 089673073
  • Email: rerro@unisa.it

Study Locations

  • Italy
    • Sa
      • Salerno, Sa, Italy, 84131
        • Recruiting
        • Centro per le Malattie Neurodegenerative (CEMAND) Dipartimento di Medicina e chirurgia, Sezione Neuroscienze, Università di Salerno
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Multiple system atrophy cerebellar variant according with the Movemente Disorder Society criteria (Wenning et al 2022)
  • Ability to walk either indipendently or with a minimum support

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)
  • 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
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real tDCS group
Partecipants receive anodal tDCS over the cerebellum area (2 cm under the inion, using a 7 × 5 cm sponge electrode), with the cathode being applied either to the right deltoid muscle (arm 1: cerebellar stimulation) or over the spinal lumbar enlargement (2 cm under T11; arm 2: cerebellar-spinal stimulation) using a sponge electrode of the same size as the anode for 5 days/week for 2 weeks
Device: Anodal transcranial direct current stimulation (a-tDCS)
tDCS is delivered by a battery-driven constant current stimulator throught a pair of saline soaked surface sponge electrodes. The active electrode (anode) is placed on the scalp over the over the cerebellum area (2 cm under the inion, using a 7 × 5 cm sponge electrode), with the cathode being applied either to the right deltoid muscle (arm 1: cerebellar stimulation) or over the spinal lumbar enlargement (2 cm under T11; arm 2: cerebellar-spinal stimulation) using a sponge electrode of the same size as the anode. Durng real stilumation a costant current of 2mA is applied for 20 minutes.
Other Names:
  • Active stimulation
Sham Comparator: Sham group
Partecipants receive sham stimulation over the cerebellum area (2 cm under the inion, using a 7 × 5 cm sponge electrode), with the cathode being applied either to the right deltoid muscle (arm 1: cerebellar stimulation) or over the spinal lumbar enlargement (2 cm under T11; arm 2: cerebellar-spinal stimulation) using a sponge electrode of the same size as the anode for 5 days/week for 2 weeks
Device: Sham stimulation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to 1 week and two weeks follow in motor symptoms as assessed with sensor recordings (OPAL system)
Time Frame: Baseline (t0), at 1 week (t1), at 2 weeks (t2)
Change from baseline to 1 week and two weeks follow in motor symptoms as assessed with sensor recordings (OPAL system), movements will be recorded with digital sensors (gait and other tasks)
Baseline (t0), at 1 week (t1), at 2 weeks (t2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changing from baseline of measures from clinical scale (SARA)
Time Frame: Baseline (t0), at 1 week (t1), at 2 weeks (t2)

Changing from baseline of measures from clinical scale:

SARA: Scale for the assessment and rating of ataxia
Baseline (t0), at 1 week (t1), at 2 weeks (t2)
Changing from baseline of measures from clinical scale (ICARS)
Time Frame: Baseline (t0), at 1 week (t1), at 2 weeks (t2)

Changing from baseline of measures from clinical scale:

ICARS: International cooperative ataxia rating scale
Baseline (t0), at 1 week (t1), at 2 weeks (t2)
Changing from baseline of measures from clinical scale (UMSARS)
Time Frame: Baseline (t0), at 1 week (t1), at 2 weeks (t2)

Changing from baseline of measures from clinical scale:

UMSARS: Unified multiple system atrophy rating scale
Baseline (t0), at 1 week (t1), at 2 weeks (t2)
Changing from baseline of measures from patient related outcome
Time Frame: Baseline (t0), at 1 week (t1), at 2 weeks (t2)
Changing from baseline of measures from patient related outcome Euro 5 dimension quality of life (EQ5D)
Baseline (t0), at 1 week (t1), at 2 weeks (t2)
Changing from baseline of measures from patient related outcome
Time Frame: Baseline (t0), at 1 week (t1), at 2 weeks (t2)
Changing from baseline of measures from patient related outcome Clinical global impression (CGI)
Baseline (t0), at 1 week (t1), at 2 weeks (t2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Salerno

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 6, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

February 11, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSA-STIM 01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multiple System Atrophy - Cerebellar Subtype (MSA-C)

Clinical Trials on Anodal transcranial direct current stimulation (a-tDCS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe