Efficacy and Safety of Transcranial dIrect Current stiMulation in Multiple System Atrophy-Cerebellar Variant

NCT06821256 | Recruiting

• 1 other identifier: MSA-STIM 01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple System Atrophy - Cerebellar Subtype (MSA-C)

Keywords

Multiple System Atrophy type C (MSA-C),; Transcranial direct current stimulation (tDCS)

Outcome Measures

Primary Outcomes (1)

• Change from baseline to 1 week and two weeks follow in motor symptoms as assessed with sensor recordings (OPAL system)

  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 Outcomes (5)

• Changing from baseline of measures from clinical scale (SARA)

  Baseline (t0), at 1 week (t1), at 2 weeks (t2)

• Changing from baseline of measures from clinical scale (ICARS)

  Baseline (t0), at 1 week (t1), at 2 weeks (t2)

• Changing from baseline of measures from clinical scale (UMSARS)

  Baseline (t0), at 1 week (t1), at 2 weeks (t2)

• Changing from baseline of measures from patient related outcome

  Baseline (t0), at 1 week (t1), at 2 weeks (t2)

• Changing from baseline of measures from patient related outcome

  Baseline (t0), at 1 week (t1), at 2 weeks (t2)

Study Arms (2)

Real tDCS group

EXPERIMENTAL

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)

Sham group

SHAM COMPARATOR

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

Interventions

Sham stimulation DEVICE

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

Sham group

Anodal transcranial direct current stimulation (a-tDCS) DEVICE

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.

Also known as: Active stimulation

Real tDCS group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salerno: lead

Study Sites (1)

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

Salerno, Sa, 84131, Italy

RECRUITING

Related Publications (4)

• Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.

  PMID: 21343407 BACKGROUND

• Erro R, Antelmi E, Bhatia KP, Latorre A, Tinazzi M, Berardelli A, Rothwell JC, Rocchi L. Reversal of Temporal Discrimination in Cervical Dystonia after Low-Frequency Sensory Stimulation. Mov Disord. 2021 Mar;36(3):761-766. doi: 10.1002/mds.28369. Epub 2020 Nov 7.

  PMID: 33159823 BACKGROUND

• Erro R, Tinazzi M, Morgante F, Bhatia KP. Non-invasive brain stimulation for dystonia: therapeutic implications. Eur J Neurol. 2017 Oct;24(10):1228-e64. doi: 10.1111/ene.13363. Epub 2017 Aug 7.

  PMID: 28782903 BACKGROUND

• Datta A, Bansal V, Diaz J, Patel J, Reato D, Bikson M. Gyri-precise head model of transcranial direct current stimulation: improved spatial focality using a ring electrode versus conventional rectangular pad. Brain Stimul. 2009 Oct;2(4):201-7, 207.e1. doi: 10.1016/j.brs.2009.03.005.

  PMID: 20648973 BACKGROUND

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Roberto Erro MD, PhD

CONTACT

089673073; rerro@unisa.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomiziation, 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: July 3, 2023
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)