Ireland
--:--IST
Recruiting Not applicable

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

NCT06821256 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2023-07-03
Last updated
2026-04-29

Condition(s) studied

Multiple System Atrophy - Cerebellar Subtype (MSA-C)

Investigational drug(s) / intervention(s)

Anodal transcranial direct current stimulation (a-tDCS)Sham stimulation

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.

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

Study 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).

Eligibility

Sex
ALL
Min age
40 Years
Max age
90 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Centro per le Malattie Neurodegenerative (CEMAND) Dipartimento di Medicina e chirurgia, Sezione Neuroscienze, Università di Salerno Salerno Sa Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06821256 on ClinicalTrials.gov ↗ ← All trials in Italy