Multiple System Atrophy - Cerebellar Subtype (MSA-C)STIM-MSANCT06821256
Efficacy and Safety of Transcranial dIrect Current stiMulation in Multiple System Atrophy-Cerebellar Variant
A study testing Anodal transcranial direct current stimulation (a-tDCS) in people with Multiple System Atrophy - Cerebellar Subtype (MSA-C), run by University of Salerno at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Multiple System Atrophy - Cerebellar Subtype (MSA-C)
- What is being tested?
- Anodal transcranial direct current stimulation (a-tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jul 2023to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Cortical or sub-cortical vascular lesions
- Seizures or severe heart problems and previous neurosurgical operations
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Centro per le Malattie Neurodegenerative (CEMAND) Dipartimento di Medicina e chirurgia, Sezione Neuroscienze, Università di Salerno
Salerno, Sa, 84131
Roberto Erro MD, PhD, 089673073, rerro@unisa.it
About this study
Official title: 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).
Read the 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.
- Being tested
- Anodal transcranial direct current stimulation (a-tDCS), Sham stimulation
- Keywords
- Multiple System Atrophy type C (MSA-C),, Transcranial direct current stimulation (tDCS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal transcranial direct current stimulation (a-tDCS)Device
Also called Active stimulation
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 stimulationDevice
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline (t0), at 1 week (t1), at 2 weeks (t2)
Secondary outcomes (5)
Changing from baseline of measures from clinical scale (SARA)
Changing from baseline of measures from clinical scale:
SARA: Scale for the assessment and rating of ataxia
Measured: Baseline (t0), at 1 week (t1), at 2 weeks (t2)
Changing from baseline of measures from clinical scale (ICARS)
Changing from baseline of measures from clinical scale:
ICARS: International cooperative ataxia rating scale
Measured: Baseline (t0), at 1 week (t1), at 2 weeks (t2)
Changing from baseline of measures from clinical scale (UMSARS)
Changing from baseline of measures from clinical scale:
UMSARS: Unified multiple system atrophy rating scale
Measured: Baseline (t0), at 1 week (t1), at 2 weeks (t2)
Changing from baseline of measures from patient related outcome
Changing from baseline of measures from patient related outcome Euro 5 dimension quality of life (EQ5D)
Measured: Baseline (t0), at 1 week (t1), at 2 weeks (t2)
Changing from baseline of measures from patient related outcome
Changing from baseline of measures from patient related outcome Clinical global impression (CGI)
Measured: Baseline (t0), at 1 week (t1), at 2 weeks (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start3 Jul 2023
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple System Atrophy - Cerebellar Subtype (MSA-C)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salerno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Erro, University of Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821256
- Sponsor's protocol ID
- MSA-STIM 01
- Acronym
- STIM-MSA
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.
PubMed 21343407Erro 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.
PubMed 33159823Erro 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.
PubMed 28782903Datta 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.
PubMed 20648973
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Transcranial dIrect Current stiMulation (tDCS) on Cerebellar Symptoms in Multiple System Atrophy-Cerebellar Variant (MSA-C) (STIM-MSA)
- ClinicalTrials.gov ID
- NCT06821256
- Acronym / sponsor ID
- STIM-MSA / MSA-STIM 01
- Keywords
- Multiple System Atrophy type C (MSA-C),, Transcranial direct current stimulation (tDCS)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of SalernoUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Real tDCS group | Experimental | Device: Anodal transcranial direct current stimulation (a-tDCS)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 |
| Sham group | Sham comparator | Device: Sham stimulationPartecipants 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 |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal transcranial direct current stimulation (a-tDCS)Also: Active stimulationtDCS 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. | Device | Real tDCS group |
| Sham stimulationFor 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 | Device | Sham group |
Primary outcome
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)
5 secondary outcomes
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 (ICARS)
Time frame: 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 patient related outcome
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Background: PubMed 21343407Stagg CJ, Nitsche MA. Physiological basis of transcranial direct current stimulation. Neuroscientist. 2011 Feb;17(1):37-53. doi: 10.1177/1073858410386614.
- Background: PubMed 33159823Erro 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.
- Background: PubMed 28782903Erro 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.
- Background: PubMed 20648973Datta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal transcranial direct current stimulation (a-tDCS) in people with Multiple System Atrophy - Cerebellar Subtype (MSA-C), run by University of Salerno at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Erro MD, PhD (089673073, rerro@unisa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06821256, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.