StrokePhase 2NCT01726673
Robots Paired With tDCS in Stroke Recovery
A Phase 2 study testing Transcranial Direct Current Stimulation (tDCS) in people with Stroke, run by Northwell Health at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
- Cognitive function sufficient enough to understand experiments and follow instructions
- Fugl-Meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)
Who cannot join
- Botox treatment within 6 weeks of enrollment
- Fixed contraction of the affected limb
- Complete flaccid paralysis of the affected limb
- History of hemorrhagic stroke
- Ongoing use of CNS active medications
- Ongoing use of psychoactive medications
- Presence of additional potential tDCS/TMS risk factors including damaged skin at site of stimulation, presence of a magnetically/mechanically active implant, metal in the head, family history of epilepsy, and personal history of seizures
Trial locations and contacts
1 site in 1 country.
United States1 site
Feinstein Institute for Medical Research
Manhasset, New York, 11030
About this study
Official title: Effects of Transcranial Direct Current Stimulation Paired With Robotic Arm Therapy on Recovery of Upper Extremity Motor Function in Stroke Patients
The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.
- Conditions
- Stroke
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Placebo sham
- Keywords
- Stroke, Cerebrovascular Accident, Cerebral Stroke, CVA, Robotic therapy, Upper extremity recovery, tDCS, Non-invasive brain stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Also called tDCS, Low intensity transcranial DC stimulator, Soterix 1x1
Placebo shamDevice
Also called tDCS sham
| Study group | Role | What they receive |
|---|---|---|
| tDCS + robotic arm therapy | Experimental | Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total) Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| tDCS sham + robotic arm therapy | Placebo comparator | Transcranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total) Receives: Device: Placebo sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Change in Upper Extremity Fugl Meyer Assessment Score
The median change in Upper Extremity Fugl-Meyer Score was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.
Measured: baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)
Secondary outcomes (2)
Median Change in WOLF Motor Function Test (WMFT)
The median change in performance time for the WOLF motor function test was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total WOLF motor function timed score is reported here in seconds, with a range 0-1800 seconds, and with lower values indicating faster completion of task and better functional status.
Measured: baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)
Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC)
The median change in Motor Power Manual Muscle Test Score for the upper extremity was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Motor Power Manual Muscle Test Score is reported here, with a range 0-100 points, and with higher values indicating better functional status.
Measured: 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionJan 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Volpe, Northwell Health
- Investigators
- Bruce T Volpe, MD, Principal investigator, Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01726673
- Sponsor's protocol ID
- 12-102B
- Status last verified
- May 2021
- First submitted
- 26 Oct 2012
- Last updated
- 14 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Edwards DJ, Krebs HI, Rykman A, Zipse J, Thickbroom GW, Mastaglia FL, Pascual-Leone A, Volpe BT. Raised corticomotor excitability of M1 forearm area following anodal tDCS is sustained during robotic wrist therapy in chronic stroke. Restor Neurol Neurosci. 2009;27(3):199-207. doi: 10.3233/RNN-2009-0470.
PubMed 19531875Moretti CB, Hamilton T, Edwards DJ, Peltz AR, Chang JL, Cortes M, Delbe ACB, Volpe BT, Krebs HI. Robotic Kinematic measures of the arm in chronic Stroke: part 2 - strong correlation with clinical outcome measures. Bioelectron Med. 2021 Dec 29;7(1):21. doi: 10.1186/s42234-021-00082-8.
PubMed 34963502Moretti CB, Edwards DJ, Hamilton T, Cortes M, Peltz AR, Chang JL, Delbem ACB, Volpe BT, Krebs HI. Robotic Kinematic measures of the arm in chronic Stroke: part 1 - Motor Recovery patterns from tDCS preceding intensive training. Bioelectron Med. 2021 Dec 29;7(1):20. doi: 10.1186/s42234-021-00081-9.
PubMed 34963501Elsner 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 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation Paired With Robotic Arm Therapy on Recovery of Upper Extremity Motor Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT01726673
- Acronym / sponsor ID
- 12-102B
- Conditions
- Stroke
- Keywords
- Stroke, Cerebrovascular Accident, Cerebral Stroke, CVA, Robotic therapy, Upper extremity recovery, tDCS, Non-invasive brain stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 15 Nov 2012 (estimated)
- Results
- Posted 16 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if multiple therapy sessions of Transcranial Direct Current Stimulation (tDCS non-invasive brain stimulation) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS + robotic arm therapy | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)Transcranial Direct Current Stimulation (tDCS) 2mA for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total) |
| tDCS sham + robotic arm therapy | Placebo comparator | Device: Placebo shamTranscranial Direct Current Stimulation sham condition (0 mA) for 20 minutes over the primary motor cortex (M1) in the affected hemisphere immediately followed by robotic arm therapy for 60 minutes, 3x per week for 12 weeks (36 sessions total) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior
- Cognitive function sufficient enough to understand experiments and follow instructions
- Fugl-Meyer assessment of 7 to 58 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)
Key exclusion criteria (7 listed)
- Botox treatment within 6 weeks of enrollment
- Fixed contraction of the affected limb
- Complete flaccid paralysis of the affected limb
- History of hemorrhagic stroke
- Ongoing use of CNS active medications
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Also: tDCS, Low intensity transcranial DC stimulator, Soterix 1x1 | Device | tDCS + robotic arm therapy |
| Placebo shamAlso: tDCS sham | Device | tDCS sham + robotic arm therapy |
Primary outcome
Median Change in Upper Extremity Fugl Meyer Assessment Score
Time frame: baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)
The median change in Upper Extremity Fugl-Meyer Score was calculated from baseline to discharge at 12 weeks (immediately following the intervention) and again at 36 weeks (6 months follow-up from the intervention) in each training condition (sham tDCS + robotics arm training vs. active tDCS + robotic arm training). The total Upper Extremity Fugl Meyer score is reported, with a range 0-66 points, and with higher values indicating better functional status.
2 secondary outcomes
Median Change in WOLF Motor Function Test (WMFT)
Time frame: baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)
Median Change in Motor Power Manual Muscle Test Score for the Upper Extremity (MRC)
Time frame: 12 weeks (immediately following the intervention) and 36 weeks (6 months after the intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19531875Edwards DJ, Krebs HI, Rykman A, Zipse J, Thickbroom GW, Mastaglia FL, Pascual-Leone A, Volpe BT. Raised corticomotor excitability of M1 forearm area following anodal tDCS is sustained during robotic wrist therapy in chronic stroke. Restor Neurol Neurosci. 2009;27(3):199-207. doi: 10.3233/RNN-2009-0470.
- Derived from this study: PubMed 34963502Moretti CB, Hamilton T, Edwards DJ, Peltz AR, Chang JL, Cortes M, Delbe ACB, Volpe BT, Krebs HI. Robotic Kinematic measures of the arm in chronic Stroke: part 2 - strong correlation with clinical outcome measures. Bioelectron Med. 2021 Dec 29;7(1):21. doi: 10.1186/s42234-021-00082-8.
- Derived from this study: PubMed 34963501Moretti CB, Edwards DJ, Hamilton T, Cortes M, Peltz AR, Chang JL, Delbem ACB, Volpe BT, Krebs HI. Robotic Kinematic measures of the arm in chronic Stroke: part 1 - Motor Recovery patterns from tDCS preceding intensive training. Bioelectron Med. 2021 Dec 29;7(1):20. doi: 10.1186/s42234-021-00081-9.
- 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.
Bruce T Volpe, MD principal investigator
Feinstein Institute for Medical Research
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 Transcranial Direct Current Stimulation (tDCS) in people with Stroke, run by Northwell Health at 1 site in United States.
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 14 May 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Median Change in Upper Extremity Fugl Meyer Assessment Score (time frame: baseline, discharge at 12 weeks (immediately following the intervention), and follow-up at 36 weeks (6 months after the intervention)). 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 NCT01726673, 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 14 May 2021.