Spinal Cord Injury CervicalNCT05390853
Active tDCS Versus Sham tDCS for Upper Limb Recovery in Incomplete Tetraplegic Patients
A study testing Active tDCS in people with Spinal Cord Injury Cervical, run by Montecatone Rehabilitation Institute S.p.A. at 1 site in Italy.
Trial summary
Spinal Cord Injury (SCI) at the cervical level results in motor and sensory impairment below the lesion level and may determine a consistent loss of the use of the upper limbs, with a substantial impact on daily life activities. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Spinal Cord Injury Cervical
- What is being tested?
- Active tDCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteItaly
- Study dates
- 24 May 2023to 27 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic SCI;
- SCI neurological level, according to the American Spinal Injury Association (ASIA) definitions, from C3 to C7, included;
- incomplete SCI (i.e. ASIA Impairment Scale: B, C or D);
- distance from the SCI event: from 3 to 6 months;
- residual motor ability of the target upper limb;
- stable clinical conditions;
- tolerance to sitting position for at least 45 minutes;
- subjects capable and collaborating, able to give informed consent in person.
Who cannot join
- presence of implanted devices (e.g. pacemakers, intrathecal infusers, neurostimulators, hearing aids);
- positive history of brain lesions;
- presence of cerebral metallic implants (clips) or intracranial implants (e.g. ventriculoperitoneal shunt);
- history of epilepsy or previous state of epileptic disease;
- mechanical ventilation in place;
- history of psychotic disorders;
Show all 13Show fewer
- history of severe neurodegenerative disease;
- concomitant pre-existing clinical conditions that may interfere with movements of the target arm or hand (e.g. severe osteoarthritis, joint injuries, plexus injuries, peripheral nerve injuries, partial amputations);
- use of antiepileptic drugs blocking Sodium o Calcium channels (e.g. Carbamazepine) or N-Methyl-D-Aspartate receptor antagonists (e.g. Dextromethorphan);
- history of drugs abuse;
- further contraindications to the use of TMS for PEMs elicitation (e.g. migraine with aura, permanent head / face tattoos);
- presence of brain tumor;
- pregnancy in progress.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Randomized Controlled Study on Neuromodulation Through Active tDCS Versus Sham tDCS to Support Upper Limb Motor and Functional Recovery in Sub-acute, Incomplete, Tetraplegic Spinal Cord Injured Patients
Spinal Cord Injury (SCI) at the cervical level results in motor and sensory impairment below the lesion level and may determine a consistent loss of the use of the upper limbs, with a substantial impact on daily life activities. Therefore, functionality recovery of the upper limbs, of the hands in particular, represents a priority rehabilitation target. Studies in the literature show that the most relevant recovery occurs in the first months after SCI and that neuromodulation techniques may facilitate it. Transcranial Direct Current Stimulation (tDCS ) is a non-invasive neuromodulation technique. The present pilot, randomized controlled study aims at exploring the feasibility and efficacy of an early application of tDCS, in addition to the traditional physiotherapy treatment for the functional recovery of the upper limb, in incomplete traumatic tetraplegic subjects in the sub-acute phase after SCI occurrence. Patients hospitalized at the Montecatone Rehabilitation Institute are randomly assigned to Active tDCS or Sham tDCS.
Read the detailed description
Spinal Cord Injury (SCI) at the cervical level results in motor and sensory impairment below the lesion level and may determine a consistent loss of the use of the upper limbs, with a substantial impact on daily life activities. Therefore, functionality recovery of upper limbs, of the hands in particular, represents a priority rehabilitation target. In cases of incomplete tetraplegia, the main rehabilitation goal is the recovery of the maximum functional capacity, in order to improve autonomy or, in the most serious cases, avoid complications due to immobilization.
Studies in the literature show that the most relevant recovery occurs in the first months after SCI and that neuromodulation techniques may facilitate it.
Transcranial Direct Current Stimulation (tDCS ) is a non-invasive neuromodulation technique capable of modifying cortical excitability through direct, low intensity current, generated by a programmable medical device and delivered through electrodes placed on the scalp. Some authors have explored its potential role in facilitating functional recovery and treating spasticity in SCI subjects, however there are few studies on the use of neuromodulation induced by tDCS as an aid for the functional recovery of upper limbs in tetraplegic subjects. Moreover, most of such studies are on chronic SCI persons only.
The present pilot, randomized controlled study aims at exploring the feasibility and efficacy of an early application of tDCS, in the sub-acute phase after SCI occurrence, for the functional recovery of the upper limb, in addition to the traditional physiotherapy treatment, in incomplete traumatic tetraplegic patients, hospitalized at the Montecatone Rehabilitation Institute. They are randomly assigned to Active tDCS (A) or Sham tDCS (S) (parallel arms design,1:1 allocation ratio). Two tDCS daily sessions for 5 days a week, for 2 consecutive weeks, are carried out simultaneously with the usual rehabilitation treatment of the upper limb, that is administered also at least 4 weeks before and 4 weeks after the tDCS treatment period.
Most outcomes are measured up to 4 weeks after the completion of the tDCS treatment period.
- Conditions
- Spinal Cord Injury Cervical
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- Neuromodulation, Transcranial Direct Current Stimulation, tDCS, Upper limb, Functional recovery, Early rehabilitation, Incomplete tetraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSProcedure or surgery
tDCS application is anodic, in the M1 area (Primary Motor Cortex) right or left, contralateral to the pre-defined target limb. The cathode is positioned in the supraorbital area, contralateral to the anode.
Active stimulation is carried out with a current intensity of 2 milliAmpere. Each tDCS session lasts 20 minutes. tDCS is administered simultaneously during the first 20 minutes of the usual upper limb rehabilitation physiotherapy, which will continue for a further 20 minutes.
During the whole study period (10 weeks) each patient is not subjected to any focal treatments in the target upper limb.
In the study period, the contralateral limb is rehabilitated and evaluated according to usual practice.
Sham tDCSProcedure or surgery
tDCS application is anodic, in the M1 area (Primary Motor Cortex) right or left, contralateral to the pre-defined target limb. The cathode is positioned in the supraorbital area, contralateral to the anode.
Sham stimulation is carried out through a dedicated program, which increases the current for several seconds up to the target intensity and then decreases it gradually in a few seconds, so that subjects experience the same itching and tingling experience as in active stimulation, but they do not receive any significant therapeutic currents.
Each tDCS session lasts 20 minutes. tDCS is administered simultaneously during the first 20 minutes of the usual upper limb rehabilitation physiotherapy, which will continue for a further 20 minutes.
During the whole study period (10 weeks) each patient is not subjected to any focal treatments in the target upper limb.
In the study period, the contralateral limb is rehabilitated and evaluated according to usual practice.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS (A) | Experimental | Two daily tDCS sessions for 5 days a week, for 2 consecutive weeks, are carried out, simultaneously with the usual rehabilitation physiotherapy of the upper limbs.
Patients will receive the usual rehabilitation physiotherapy of the upper limbs at least in the 4 weeks before and in the 4 weeks after the tDCS treatment period too. Receives: Procedure: Active tDCS |
| Sham tDCS (S) | Placebo comparator | Two daily tDCS sessions for 5 days a week, for 2 consecutive weeks, are carried out, simultaneously with the usual rehabilitation physiotherapy of the upper limbs.
Patients will receive the usual rehabilitation physiotherapy of the upper limbs at least in the 4 weeks before and in the 4 weeks after the tDCS treatment period too. Receives: Procedure: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in motor function, after the tDCS treatment period completion
Motor function (i.e. muscle strength) of the target upper limb, determined according to the Medical Research Council /International Classification for the Surgery of the Tetraplegic Hand (MRC/ICSTH)
Measured: Baseline 1 (initial visit); Baseline 2 (second visit, 2 weeks after Baseline 1); just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1)
Secondary outcomes (8)
Permanence of motor function, 4 weeks after the tDCS treatment period completion
Motor function (i.e. muscle strength) of the target upper limb, determined according to the Medical Research Council /International Classification for the Surgery of the Tetraplegic Hand (MRC/ICSTH)
Measured: Just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)
Change in strength, sensitivity and grip, up to 4 weeks after the tDCS treatment period completion
Strength, sensitivity and grip of the target upper limb, determined according to the Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP)
Measured: Baseline 1 (initial visit); Baseline 2 (second visit, 2 weeks after Baseline 1); just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)
Change in spasticity, up to 4 weeks after the tDCS treatment period completion
Spasticity of the target upper limb, determined according to the Modified Ashworth Scale (MAS)
Measured: Baseline 1 (initial visit); Baseline 2 (second visit, 2 weeks after Baseline 1); just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)
Change in motor function and muscle activity during rest activity, from the beginning of the tDCS treatment period until 4 weeks after its completion
Motor function and muscle activity during rest activity, determined through Neurographic assessment of the following muscles: deltoid, biceps, carpus extensor, thumb abductor brevis
Measured: just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)
Change in Motor Evoked Potentials, from the beginning of the tDCS treatment period until 4 weeks after its completion
Motor Evoked Potentials (PEMs), elicited by Transcranial Magnetic Stimulation (TMS), of the following muscles: deltoid, biceps, carpus extensor, thumb abductor brevis
Measured: just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)
Pain, up to 4 weeks after the tDCS treatment period completion
Pain assessment in the target upper limb, determined according to the Numeric Rating Scale (NRS)
Measured: Baseline 1 (initial visit); Baseline 2 (2 weeks after Baseline 1); just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1
Safety of the tDCS treatment
Incidence of adverse events related to the tDCS treatments
Measured: During and after each tDCS session (from week 4 to week 6 after Baseline 1); in the 4 weeks after tDCS session n.20 (up to 10 weeks after Baseline 1)
Tolerability of the tDCS treatment
Subjective patient's perception of the fatigue of the treatments with tDCS associated with the usual rehabilitation physiotherapy treatment of the upper limb, evaluated through a short in-house developed questionnaire
Measured: Just after tDCS session n.20 (week 6 after Baseline 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start24 May 2023
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Why it stopped: Recruitment inefficiency, due to overly stringent selection criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury CervicalStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Olivi, MD, Principal investigator, Montecatone Rehabilitation Institute S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390853
- Sponsor's protocol ID
- CE AVEC_96-2022-SPER-AUSLIM
- Status last verified
- May 2026
- First submitted
- 20 May 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Study on Neuromodulation Through Active tDCS Versus Sham tDCS to Support Upper Limb Motor and Functional Recovery in Sub-acute, Incomplete, Tetraplegic Spinal Cord Injured Patients
- ClinicalTrials.gov ID
- NCT05390853
- Acronym / sponsor ID
- CE AVEC_96-2022-SPER-AUSLIM
- Conditions
- Spinal Cord Injury Cervical
- Keywords
- Neuromodulation, Transcranial Direct Current Stimulation, tDCS, Upper limb, Functional recovery, Early rehabilitation, Incomplete tetraplegia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment inefficiency, due to overly stringent selection criteria
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Montecatone Rehabilitation Institute S.p.A.University, hospital or other
- Study start
- 24 May 2023 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 25 May 2022 (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.
Spinal Cord Injury (SCI) at the cervical level results in motor and sensory impairment below the lesion level and may determine a consistent loss of the use of the upper limbs, with a substantial impact on daily life activities. Therefore, functionality recovery of the upper limbs, of the hands in particular, represents a priority rehabilitation target. Studies in the literature show that the most relevant recovery occurs in the first months after SCI and that neuromodulation techniques may facilitate it. Transcranial Direct Current Stimulation (tDCS ) is a non-invasive neuromodulation technique. The present pilot, randomized controlled study aims at exploring the feasibility and efficacy of an early application of tDCS, in addition to the traditional physiotherapy treatment for the functional recovery of the upper limb, in incomplete traumatic tetraplegic subjects in the sub-acute phase after SCI occurrence. Patients hospitalized at the Montecatone Rehabilitation Institute are randomly assigned to Active tDCS or Sham tDCS.
Detailed description
Spinal Cord Injury (SCI) at the cervical level results in motor and sensory impairment below the lesion level and may determine a consistent loss of the use of the upper limbs, with a substantial impact on daily life activities. Therefore, functionality recovery of upper limbs, of the hands in particular, represents a priority rehabilitation target. In cases of incomplete tetraplegia, the main rehabilitation goal is the recovery of the maximum functional capacity, in order to improve autonomy or, in the most serious cases, avoid complications due to immobilization.
Studies in the literature show that the most relevant recovery occurs in the first months after SCI and that neuromodulation techniques may facilitate it.
Transcranial Direct Current Stimulation (tDCS ) is a non-invasive neuromodulation technique capable of modifying cortical excitability through direct, low intensity current, generated by a programmable medical device and delivered through electrodes placed on the scalp. Some authors have explored its potential role in facilitating functional recovery and treating spasticity in SCI subjects, however there are few studies on the use of neuromodulation induced by tDCS as an aid for the functional recovery of upper limbs in tetraplegic subjects. Moreover, most of such studies are on chronic SCI persons only.
The present pilot, randomized controlled study aims at exploring the feasibility and efficacy of an early application of tDCS, in the sub-acute phase after SCI occurrence, for the functional recovery of the upper limb, in addition to the traditional physiotherapy treatment, in incomplete traumatic tetraplegic patients, hospitalized at the Montecatone Rehabilitation Institute. They are randomly assigned to Active tDCS (A) or Sham tDCS (S) (parallel arms design,1:1 allocation ratio). Two tDCS daily sessions for 5 days a week, for 2 consecutive weeks, are carried out simultaneously with the usual rehabilitation treatment of the upper limb, that is administered also at least 4 weeks before and 4 weeks after the tDCS treatment period.
Most outcomes are measured up to 4 weeks after the completion of the tDCS treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS (A) | Experimental | Procedure: Active tDCSTwo daily tDCS sessions for 5 days a week, for 2 consecutive weeks, are carried out, simultaneously with the usual rehabilitation physiotherapy of the upper limbs. Patients will receive the usual rehabilitation physiotherapy of the upper limbs at least in the 4 weeks before and in the 4 weeks after the tDCS treatment period too. |
| Sham tDCS (S) | Placebo comparator | Procedure: Sham tDCSTwo daily tDCS sessions for 5 days a week, for 2 consecutive weeks, are carried out, simultaneously with the usual rehabilitation physiotherapy of the upper limbs. Patients will receive the usual rehabilitation physiotherapy of the upper limbs at least in the 4 weeks before and in the 4 weeks after the tDCS treatment period too. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Traumatic SCI;
- SCI neurological level, according to the American Spinal Injury Association (ASIA) definitions, from C3 to C7, included;
- incomplete SCI (i.e. ASIA Impairment Scale: B, C or D);
- distance from the SCI event: from 3 to 6 months;
- residual motor ability of the target upper limb;
Key exclusion criteria (13 listed)
- presence of implanted devices (e.g. pacemakers, intrathecal infusers, neurostimulators, hearing aids);
- positive history of brain lesions;
- presence of cerebral metallic implants (clips) or intracranial implants (e.g. ventriculoperitoneal shunt);
- history of epilepsy or previous state of epileptic disease;
- mechanical ventilation in place;
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 |
|---|---|---|
| Active tDCStDCS application is anodic, in the M1 area (Primary Motor Cortex) right or left, contralateral to the pre-defined target limb. The cathode is positioned in the supraorbital area, contralateral to the anode. Active stimulation is carried out with a current intensity of 2 milliAmpere. Each tDCS session lasts 20 minutes. tDCS is administered simultaneously during the first 20 minutes of the usual upper limb rehabilitation physiotherapy, which will continue for a further 20 minutes. During the whole study period (10 weeks) each patient is not subjected to any focal treatments in the target upper limb. In the study period, the contralateral limb is rehabilitated and evaluated according to usual practice. | Procedure or surgery | Active tDCS (A) |
| Sham tDCStDCS application is anodic, in the M1 area (Primary Motor Cortex) right or left, contralateral to the pre-defined target limb. The cathode is positioned in the supraorbital area, contralateral to the anode. Sham stimulation is carried out through a dedicated program, which increases the current for several seconds up to the target intensity and then decreases it gradually in a few seconds, so that subjects experience the same itching and tingling experience as in active stimulation, but they do not receive any significant therapeutic currents. Each tDCS session lasts 20 minutes. tDCS is administered simultaneously during the first 20 minutes of the usual upper limb rehabilitation physiotherapy, which will continue for a further 20 minutes. During the whole study period (10 weeks) each patient is not subjected to any focal treatments in the target upper limb. In the study period, the contralateral limb is rehabilitated and evaluated according to usual practice. | Procedure or surgery | Sham tDCS (S) |
Primary outcome
Change in motor function, after the tDCS treatment period completion
Time frame: Baseline 1 (initial visit); Baseline 2 (second visit, 2 weeks after Baseline 1); just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1)
Motor function (i.e. muscle strength) of the target upper limb, determined according to the Medical Research Council /International Classification for the Surgery of the Tetraplegic Hand (MRC/ICSTH)
8 secondary outcomes
Permanence of motor function, 4 weeks after the tDCS treatment period completion
Time frame: Just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)
Change in strength, sensitivity and grip, up to 4 weeks after the tDCS treatment period completion
Time frame: Baseline 1 (initial visit); Baseline 2 (second visit, 2 weeks after Baseline 1); just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)
Change in spasticity, up to 4 weeks after the tDCS treatment period completion
Time frame: Baseline 1 (initial visit); Baseline 2 (second visit, 2 weeks after Baseline 1); just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)
Change in motor function and muscle activity during rest activity, from the beginning of the tDCS treatment period until 4 weeks after its completion
Time frame: just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)
Change in Motor Evoked Potentials, from the beginning of the tDCS treatment period until 4 weeks after its completion
Time frame: just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1)
Pain, up to 4 weeks after the tDCS treatment period completion
Time frame: Baseline 1 (initial visit); Baseline 2 (2 weeks after Baseline 1); just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1); 4 weeks after tDCS session n.20 (10 weeks after Baseline 1
Safety of the tDCS treatment
Time frame: During and after each tDCS session (from week 4 to week 6 after Baseline 1); in the 4 weeks after tDCS session n.20 (up to 10 weeks after Baseline 1)
Tolerability of the tDCS treatment
Time frame: Just after tDCS session n.20 (week 6 after Baseline 1)
Results and safety
The study was stopped early (reason given: Recruitment inefficiency, due to overly stringent selection criteria). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Silvia Olivi, MD principal investigator
Montecatone Rehabilitation Institute S.p.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS in people with Spinal Cord Injury Cervical, run by Montecatone Rehabilitation Institute S.p.A. 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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 8 May 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?
The study was stopped early (reason given: Recruitment inefficiency, due to overly stringent selection criteria). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in motor function, after the tDCS treatment period completion (time frame: Baseline 1 (initial visit); Baseline 2 (second visit, 2 weeks after Baseline 1); just before tDCS session n.1 (4 weeks after Baseline 1); just after tDCS session n.20 (6 weeks after Baseline 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2026.