StrokePhase 2NCT01828398
tDCS and Robotic Therapy in Stroke
A Phase 2 study testing real-tDCS + UE robot-assisted therapy in people with Stroke and Upper Extremity Impairments, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Upper Extremity Impairments
- What is being tested?
- real-tDCS + UE robot-assisted therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2011to Nov 2013
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females subjects. Age > 18 years.
- Diagnosis of first ischemic stroke
- Impairment of the upper limb
- Trunk control defined in the Trunk-Control Test (TCT), with a score > 50.
Who cannot join
- anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
- Impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
- contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
- Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current
- Neurological or psychiatric pathology
- severe cardio-pulmonary, renal, hepatic diseases
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.
The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.
- Conditions
- Stroke, Upper Extremity Impairments
- Being tested
- real-tDCS + UE robot-assisted therapy, sham-tDCS + UE robot-assisted therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real-tDCS + UE robot-assisted therapyDevice
sham-tDCS + UE robot-assisted therapyDevice
| Study group | Role | What they receive |
|---|---|---|
| sham-tDCS + UE robot-assisted therapy | Sham comparator | This group will receive the same robot-assisted therapy of the intervention group, in association of sham-tDCS. This consists in a 30 seconds stimulation, with the same instrumentation and electrodes placement. This method of sham stimulation was previously validated. Receives: Device: sham-tDCS + UE robot-assisted therapy |
| real-tDCS + UE robot-assisted therapy | Experimental | This group will receive continuous stimulation lasting 30 minutes during the session of robot-assisted therapy. The training session, which includes multiplanar, repetitive and target reaching movements, will be given 5 times a week for 2 weeks(REO Therapy System; Motorika, Medical LTD, Israel). Each session will last about 30 minutes.
Transcranial direct current stimulation (tDCS) will be administered as follows. The anode will be placed on the primary motor cortex (M1) of the affected hemisphere and the cathode on the contralateral M1 area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries (Brainstim, EMS, Italy). This continuous stimulation lasted 30 minutes, with an intensity of 1mA. Receives: Device: real-tDCS + UE robot-assisted therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
Measured: A week prior to treatment beginning
Secondary outcomes (4)
Box and Block Test
Test for gross motor function. It counts the number of blocks that can be transported from one compartment of a box to another compartment within 1 minute.
Measured: A week prior to treatment beginning
Ashworth Modified Scale
a 6 point measure of spasticity. We will assess the spasticity at the shoulder, elbow and, wrist
Measured: A week prior to treatment beginning
Motor Activity Log (MAL)
Assessment of the change in real-world arm use in activities of daily living. Subjects are asked to score the quality of movement as well as amount of use of the affected arm in a number of common daily activities.
Measured: A week prior to treatment beginning
Assessment of cortical excitability (TMS)
MEP of upper limb muscles (first dorsal interosseous) will be recorded with surface EMG electrodes. neurophysiological parameters analyzed:
- motor threshold at rest
- MEP recruitment curve at rest
- MEP amplitude
Measured: A week prior to treatment beginning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startNov 2011
- Primary completionSep 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Straudi, MD, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828398
- Sponsor's protocol ID
- Stroke_tDCS
- Status last verified
- Jan 2014
- First submitted
- 5 Apr 2013
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PubMed 33175411
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tDCS and Robotic Therapy in Stroke
- ClinicalTrials.gov ID
- NCT01828398
- Acronym / sponsor ID
- Stroke_tDCS
- Conditions
- Stroke, Upper Extremity Impairments
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Apr 2013 (estimated)
- 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.
After stroke a limited motor recovery in the paretic upper limb accounts for a large proportion of the disabling sequelae. Only about 15% of those with initial complete upper limb paralysis after stroke recover functional use of their impaired arm in daily life.
The aim of this study is to test the effects of tDCS combined with upper extremity robot-assisted therapy on stroke survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sham-tDCS + UE robot-assisted therapy | Sham comparator | Device: sham-tDCS + UE robot-assisted therapyThis group will receive the same robot-assisted therapy of the intervention group, in association of sham-tDCS. This consists in a 30 seconds stimulation, with the same instrumentation and electrodes placement. This method of sham stimulation was previously validated. |
| real-tDCS + UE robot-assisted therapy | Experimental | Device: real-tDCS + UE robot-assisted therapyThis group will receive continuous stimulation lasting 30 minutes during the session of robot-assisted therapy. The training session, which includes multiplanar, repetitive and target reaching movements, will be given 5 times a week for 2 weeks(REO Therapy System; Motorika, Medical LTD, Israel). Each session will last about 30 minutes. Transcranial direct current stimulation (tDCS) will be administered as follows. The anode will be placed on the primary motor cortex (M1) of the affected hemisphere and the cathode on the contralateral M1 area. The direct current is transmitted through a pair of sponge electrodes, with a surface of 35 cm2 (7x5), soaked in saline solution and, it is generated by a constant current stimulator, with rechargeable batteries (Brainstim, EMS, Italy). This continuous stimulation lasted 30 minutes, with an intensity of 1mA. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females subjects. Age > 18 years.
- Diagnosis of first ischemic stroke
- Impairment of the upper limb
- Trunk control defined in the Trunk-Control Test (TCT), with a score > 50.
Key exclusion criteria (7 listed)
- anyone who does not have adequate understanding of verbal or written information in Italian sufficient to complete any test
- Impaired cognitive functioning: score less than 24 on the Mini Mental Status Examination (MMSE)
- contraindications to single-pulse transcranial magnetic stimulation (TMS)(TMS will be used to measure cortical excitability): presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants)
- Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current
- Neurological or psychiatric pathology
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 |
|---|---|---|
| real-tDCS + UE robot-assisted therapy | Device | real-tDCS + UE robot-assisted therapy |
| sham-tDCS + UE robot-assisted therapy | Device | sham-tDCS + UE robot-assisted therapy |
Primary outcome
Fugl-Meyer Upper Extremity
Time frame: A week prior to treatment beginning
Measure of upper extremity motor impairment. The upper extremity score ranges from 0-66.
4 secondary outcomes
Box and Block Test
Time frame: A week prior to treatment beginning
Ashworth Modified Scale
Time frame: A week prior to treatment beginning
Motor Activity Log (MAL)
Time frame: A week prior to treatment beginning
Assessment of cortical excitability (TMS)
Time frame: A week prior to treatment beginning
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2014.
- Derived from this study: PubMed 33175411Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing real-tDCS + UE robot-assisted therapy in people with Stroke and Upper Extremity Impairments, run by University Hospital of Ferrara 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 16 Jan 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Fugl-Meyer Upper Extremity (time frame: A week prior to treatment beginning). 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 NCT01828398, which also lists 1 linked publication.
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 16 Jan 2014; AzTrials last refreshed its copy on 1 Nov 2026.