StrokePhase 2NCT01883843
Efficacy of TOCT and (tDCS) for Gait Improvement in Patients With Chronic Stroke
A Phase 2 study testing real tDCS + TOCT in people with Stroke, run by University Hospital of Ferrara at 1 site in Italy.
Trial summary
Stroke is one of the major causes of disability in the Western world. Initially gait is the most affected function, 80% of patients lose this ability. Rehabilitation in stroke patients improves walking abilities in terms of gait and related gait activities, though six months after stroke many patients are… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- real tDCS + TOCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Sep 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females subjects. Age > 18 years, <75 years.
- Diagnosis of first ischemic stroke > 6 months.
- MMSE>24;
- FAC higher or equal to 4
Who cannot join
- Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current, presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants).
- Neurological or psychiatric pathology.
- Severe cardio-pulmonary, renal, hepatic diseases.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Task-oriented Circuit Training Associated With Transcranial Direct Current Stimulation (tDCS) for Gait Improvement in Chronic Stroke Patients . A Randomized Controlled Trial
Stroke is one of the major causes of disability in the Western world. Initially gait is the most affected function, 80% of patients lose this ability.
Rehabilitation in stroke patients improves walking abilities in terms of gait and related gait activities, though six months after stroke many patients are significantly disabled.
Read more
Recently, a prospective study of 205 stroke patients showed that approximately 21% of patients have a significant decrease of mobility between the first and the third year after stroke. The main finding showed that inactivity was the most important factor for the mobility decline.
Evidence about effects of direct current brain stimulation on motor recovery function of lower limb are still little, some show that quadriceps strength after stimulation of damaged M1 area increased. Another study where tDCS was associated with robotic gait training did not report any effect compared to treatment alone. It is necessary to define if a different dosage of stimulation or the association of tDCS with gait training can improve walking and if further studies are required to investigate their effectiveness.
The aim of this clinical trial is to test the possibility of gait improvement through the association of tDCS with a specific task-oriented circuit training for walking abilities, balance and mobility.
Read the detailed description
Inclusion criteria:
- Males and females subjects. Age > 18 years, <75 years.
- Diagnosis of first ischemic stroke > 6 months.
- Mini mental State Examination (MMSE) >24;
- Functional Ambulation Classification (FAC) higher or equal to 4
- Conditions
- Stroke
- Being tested
- sham tDCS + TOCT, real tDCS + TOCT
- Keywords
- Chronic Stroke, tDCS, transcranial direct current stimulation, task oriented circuit training, TOCT, gait training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham tDCS + TOCTDevice
Every day will be given a continuous low-intensity stimulation of 0.5mA (for a current density of 60μA/cm2) only for 10 seconds at the beginning and at the end of the stimulation for 10 consecutive days after any rehabilitative treatment. The mounting of electrodes for sham stimulation is the same used for the experimental group.
real tDCS + TOCTDevice
Every day will be given continuous stimulation duration of 15 minutes with intensity of 0.5 mA (for a current density of 60μA/cm2), generated by a constant current stimulator rechargeable batteries for 10 consecutive days after any rehabilitation treatment in the gym. Two sponge electrodes are placed, soaked in saline solution, fixed by an elastic band, the anode consists of an electrode oblong 8cm2 positioned at M1 area on the lower limb affection (following the medial sagittal axis, with the center of the electrode positioned at one centimeter laterally to the vertex) while the cathode (48cm2) is placed in the contralateral supraorbitale area as reference electrode. The current reaches 0.5mA and decreases with a ramp of 10 seconds.
| Study group | Role | What they receive |
|---|---|---|
| real tDCS + TOCT | Experimental | Every day will be given continuous stimulation duration of 15 minutes with intensity of 0.5 mA (for a current density of 60μA/cm2), generated by a constant current stimulator rechargeable batteries for 10 consecutive days after any rehabilitation treatment in the gym. Two sponge electrodes are placed, soaked in saline solution, fixed by an elastic band, the anode consists of an electrode oblong 8cm2 positioned at M1 area on the lower limb affection (following the medial sagittal axis, with the center of the electrode positioned at one centimeter laterally to the vertex) while the cathode (48cm2) is placed in the contralateral supraorbitale area as reference electrode.
The current reaches 0.5mA and decreases with a ramp of 10 seconds. Receives: Device: real tDCS + TOCT |
| sham tDCS + TOCT | Active comparator | Every day will be given a continuous low-intensity stimulation of 0.5mA (for a current density of 60μA/cm2) only for 10 seconds at the beginning and at the end of the stimulation for 10 consecutive days after any rehabilitative treatment. The mounting of electrodes for sham stimulation is the same used for the experimental group. Receives: Device: sham tDCS + TOCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT)
Measured: 1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up.
Secondary outcomes (6)
10 meter walking test (test of 10m)
walking speed test
Measured: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up
Timed "up and go" test (TUG)
Measured: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Unified Balance Scale (UBS)
Measured: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Fatigue Severity Scale (FSS)
Measured: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Stroke Impact Scale (SIS) version 3.0
Measured: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Stroke Specific Quality of Life (SS-QOL)
Measured: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2014
- Study completionSep 2014
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 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
- Investigators
- Sofia Straudi, MD, Principal investigator, Ferrara Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883843
- Sponsor's protocol ID
- Stroke_tDCS_TOCT
- Status last verified
- Dec 2014
- First submitted
- 14 Jun 2013
- Last updated
- 23 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
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 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Task-oriented Circuit Training Associated With Transcranial Direct Current Stimulation (tDCS) for Gait Improvement in Chronic Stroke Patients . A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01883843
- Acronym / sponsor ID
- Stroke_tDCS_TOCT
- Conditions
- Stroke
- Keywords
- Chronic Stroke, tDCS, transcranial direct current stimulation, task oriented circuit training, TOCT, gait training
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 21 Jun 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.
Stroke is one of the major causes of disability in the Western world. Initially gait is the most affected function, 80% of patients lose this ability.
Rehabilitation in stroke patients improves walking abilities in terms of gait and related gait activities, though six months after stroke many patients are significantly disabled.
Recently, a prospective study of 205 stroke patients showed that approximately 21% of patients have a significant decrease of mobility between the first and the third year after stroke. The main finding showed that inactivity was the most important factor for the mobility decline.
Evidence about effects of direct current brain stimulation on motor recovery function of lower limb are still little, some show that quadriceps strength after stimulation of damaged M1 area increased. Another study where tDCS was associated with robotic gait training did not report any effect compared to treatment alone. It is necessary to define if a different dosage of stimulation or the association of tDCS with gait training can improve walking and if further studies are required to investigate their effectiveness.
The aim of this clinical trial is to test the possibility of gait improvement through the association of tDCS with a specific task-oriented circuit training for walking abilities, balance and mobility.
Detailed description
Inclusion criteria:
- Males and females subjects. Age > 18 years, <75 years.
- Diagnosis of first ischemic stroke > 6 months.
- Mini mental State Examination (MMSE) >24;
- Functional Ambulation Classification (FAC) higher or equal to 4
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| real tDCS + TOCT | Experimental | Device: real tDCS + TOCTEvery day will be given continuous stimulation duration of 15 minutes with intensity of 0.5 mA (for a current density of 60μA/cm2), generated by a constant current stimulator rechargeable batteries for 10 consecutive days after any rehabilitation treatment in the gym. Two sponge electrodes are placed, soaked in saline solution, fixed by an elastic band, the anode consists of an electrode oblong 8cm2 positioned at M1 area on the lower limb affection (following the medial sagittal axis, with the center of the electrode positioned at one centimeter laterally to the vertex) while the cathode (48cm2) is placed in the contralateral supraorbitale area as reference electrode. The current reaches 0.5mA and decreases with a ramp of 10 seconds. |
| sham tDCS + TOCT | Active comparator | Device: sham tDCS + TOCTEvery day will be given a continuous low-intensity stimulation of 0.5mA (for a current density of 60μA/cm2) only for 10 seconds at the beginning and at the end of the stimulation for 10 consecutive days after any rehabilitative treatment. The mounting of electrodes for sham stimulation is the same used for the experimental group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females subjects. Age > 18 years, <75 years.
- Diagnosis of first ischemic stroke > 6 months.
- MMSE>24;
- FAC higher or equal to 4
Key exclusion criteria (4 listed)
- Contraindications to tDCS: intracranial metal implants that can be stimulated, incorrectly positioned or over-heated by the electric current, presence of a history of epilepsy, frequent headaches or neck pain, implantable devices (ventriculoperitoneal shunts, pacemakers, intrathecal pumps, intracranial metal implants).
- Neurological or psychiatric pathology.
- Severe cardio-pulmonary, renal, hepatic diseases.
- Pregnancy.
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 |
|---|---|---|
| sham tDCS + TOCTEvery day will be given a continuous low-intensity stimulation of 0.5mA (for a current density of 60μA/cm2) only for 10 seconds at the beginning and at the end of the stimulation for 10 consecutive days after any rehabilitative treatment. The mounting of electrodes for sham stimulation is the same used for the experimental group. | Device | sham tDCS + TOCT |
| real tDCS + TOCTEvery day will be given continuous stimulation duration of 15 minutes with intensity of 0.5 mA (for a current density of 60μA/cm2), generated by a constant current stimulator rechargeable batteries for 10 consecutive days after any rehabilitation treatment in the gym. Two sponge electrodes are placed, soaked in saline solution, fixed by an elastic band, the anode consists of an electrode oblong 8cm2 positioned at M1 area on the lower limb affection (following the medial sagittal axis, with the center of the electrode positioned at one centimeter laterally to the vertex) while the cathode (48cm2) is placed in the contralateral supraorbitale area as reference electrode. The current reaches 0.5mA and decreases with a ramp of 10 seconds. | Device | real tDCS + TOCT |
Primary outcome
Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT)
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up.
6 secondary outcomes
10 meter walking test (test of 10m)
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up
Timed "up and go" test (TUG)
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Unified Balance Scale (UBS)
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Fatigue Severity Scale (FSS)
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Stroke Impact Scale (SIS) version 3.0
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
Stroke Specific Quality of Life (SS-QOL)
Time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3)three months follow up.
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 23 Dec 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.
Sofia Straudi, MD principal investigator
Ferrara Rehabilitation Hospital
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 + TOCT in people with Stroke, 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 4 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 23 Dec 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. 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?
Change from baseline in walking abilities, balance and mobility in Six minutes walking test (6MWT) (time frame: 1)A week prior to treatment beginning 2) the week after treatment end 3) three months follow up.). 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 NCT01883843, 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 23 Dec 2014.