Functional RecoveryAMPLI-MOVNCT06826274
Cervical TsDCS on Stroke Patients
A study testing tDCS in people with Functional Recovery and Motor Rehabilitation, run by IRCCS San Raffaele Roma at 1 site in Italy.
Trial summary
The present project aims to evaluate the facilitatory modulation of motor responses of the limb upper limb by tsDCS in patients with arm/hand hyposthenia after cerebral ischemia to verify the possible therapeutic benefits that this type of stimulation can induce in terms of of strength, dexterity and effectiveness in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Functional Recovery, Motor Rehabilitation
- What is being tested?
- tDCS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2025to Mar 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age over 18 years;
- first ischemic/hemorrhagic stroke (within 30 days of onset);
- mild-to-moderate stroke (NIHSS scale score<16).
- residual function of the upper limb, assessed by the following scales: - MRC of the distal muscles of the upper limb: score between 2 and 4; - NHISS (items 5A and 5B): score between 1 and 3;
- ability to give informed consent and understand instructions.
- age over 18 years;
- equalized in age with the patient group.
Who cannot join
- severe spasticity (Ashworth Scale score > 2);
- severe aphasia;
- severe neglect;
- history of disabling neurological disease;
- history of epilepsy;
- significant comorbidities;
Show all 10Show fewer
- contraindications to tsDCS.
- Healthy Group:
- history of stroke progress;
- history of severe neurological disease.
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
IRCCS San Raffaele Roma
Rome, Rome, 00163
Fabrizio v, 3478031201, fabrizio.vecchio@sanraffaele.it
About this study
Official title: Clinical and Neurophysiological Evaluation of the Effects of Cervical TsDCS on Stroke Patients with Distal Upper Limb Strength Deficit
The present project aims to evaluate the facilitatory modulation of motor responses of the limb upper limb by tsDCS in patients with arm/hand hyposthenia after cerebral ischemia to verify the possible therapeutic benefits that this type of stimulation can induce in terms of of strength, dexterity and effectiveness in acts of daily living.
- Conditions
- Functional Recovery, Motor Rehabilitation
- Being tested
- tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSOther
Transcranial direct current stimulation
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Experimental | Not described Receives: Other: tDCS |
| Healthy | Experimental | Not described Receives: Other: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of paretic hand performance
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during Reaching
Measured: through study completion, an average of 1 year
improvement of paretic hand performance
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during Grasping
Measured: through study completion, an average of 1 year
improvement of paretic hand performance
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during Lifting test
Measured: through study completion, an average of 1 year
improvement of paretic hand performance
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level duringthe Nine Hole Peg test
Measured: through study completion, an average of 1 year
improvement of paretic hand performance
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during finger mobility tests
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional RecoveryStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826274
- Sponsor's protocol ID
- RP 23/06
- Acronym
- AMPLI-MOV
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Neurophysiological Evaluation of the Effects of Cervical TsDCS on Stroke Patients with Distal Upper Limb Strength Deficit
- ClinicalTrials.gov ID
- NCT06826274
- Acronym / sponsor ID
- AMPLI-MOV / RP 23/06
- Conditions
- Functional Recovery, Motor Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 13 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.
The present project aims to evaluate the facilitatory modulation of motor responses of the limb upper limb by tsDCS in patients with arm/hand hyposthenia after cerebral ischemia to verify the possible therapeutic benefits that this type of stimulation can induce in terms of of strength, dexterity and effectiveness in acts of daily living.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | Experimental | Other: tDCS |
| Healthy | Experimental | Other: tDCS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age over 18 years;
- first ischemic/hemorrhagic stroke (within 30 days of onset);
- mild-to-moderate stroke (NIHSS scale score<16).
- residual function of the upper limb, assessed by the following scales: - MRC of the distal muscles of the upper limb: score between 2 and 4; - NHISS (items 5A and 5B): score between 1 and 3;
- ability to give informed consent and understand instructions.
Key exclusion criteria (10 listed)
- severe spasticity (Ashworth Scale score > 2);
- severe aphasia;
- severe neglect;
- history of disabling neurological disease;
- history of epilepsy;
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 |
|---|---|---|
| tDCSTranscranial direct current stimulation | Other | Healthy, Stroke |
Primary outcome
improvement of paretic hand performance
Time frame: through study completion, an average of 1 year
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during Reaching
improvement of paretic hand performance
Time frame: through study completion, an average of 1 year
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during Grasping
improvement of paretic hand performance
Time frame: through study completion, an average of 1 year
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during Lifting test
improvement of paretic hand performance
Time frame: through study completion, an average of 1 year
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level duringthe Nine Hole Peg test
improvement of paretic hand performance
Time frame: through study completion, an average of 1 year
The primary outcome measure is the improvement in hand strength and dexterity in individuals with upper limb motor impairment following cerebral ischemia, after the application of tsDCS at the cervical spinal level during finger mobility tests
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 13 Feb 2025.
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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 tDCS in people with Functional Recovery and Motor Rehabilitation, run by IRCCS San Raffaele Roma 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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 13 Feb 2025. 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. 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 Fabrizio Vecchio (3478031201, fabrizio.vecchio@sanraffaele.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of paretic hand performance (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. 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 13 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.