StrokeEarly Phase 1NCT01405378
Non-invasive Brain Stimulation for People With Stroke
A Early Phase 1 study testing Robot therapy and transcranial direct current stimulation in people with Stroke, run by University of Southampton at 1 site in United Kingdom.
Trial summary
Every five minutes someone in the UK has a stroke. It is the main cause of long-term disability among adults in the UK despite a fall in age-specific stroke incidence, with a growing number of survivors remaining dependent for activities of daily living. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Robot therapy and transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2011to Feb 2014
- Phase
- Early Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a confirmed clinical diagnosis of a haemorrhagic or an ischaemic stroke confirmed clinically or by CT, PET or MRI Scan
- Experienced a single (first) stroke or multiple strokes
- In the acute, sub-acute or chronic phase of their recovery (the first three to seven days are referred to as the acute phase. The first two weeks to six months are defined as the sub-acute phase, and the chronic phase begins after three or six months (Teismann et al. 2011, Duncan et al. 2003a)
- Have had a subcortical or cortical stroke
- Be over the age of 18 years
- Have any level of upper limb impairment
Who cannot join
- A history of epilepsy (TMS studies) due to the fact that TMS could cause an epileptic fit
- Impaired gross cognitive function; score of less than 24 of the Mini-Mental State Examination (Folstein et al. 1975)
- Any metal implants in the head including cochlear implants
- Any another neurological condition apart from stroke
- Are currently participants in another intervention study using TMS/tDCS
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Faculty of Health Sciences, University of Southampton
Southampton, SO17 1BJ
About this study
Official title: Combining Transcranial Direct Current Stimulation (tDCS) With Robot Therapy for the Impaired Upper Limb in Stroke Rehabilitation.
Every five minutes someone in the UK has a stroke. It is the main cause of long-term disability among adults in the UK despite a fall in age-specific stroke incidence, with a growing number of survivors remaining dependent for activities of daily living. While most people with stroke regain walking ability, upper limb problems with no voluntary arm and hand activity, affecting a third of people after stroke, has a poor prognosis. Transcranial direct current stimulation (tDCS) is a non-invasive procedure used to polarise brain regions through the application of weak direct currents and has the potential to develop into a useful aid to treatment strategies in neurorehabilitation. Recent literature into the application of tDCS in people with arm and hand impairments after stroke has shown promising results on upper limb function measures like the Jebsen-Taylor hand function test. Furthermore, a recent pilot study evaluated a six-week training programme combining tDCS with robot-assisted hand training and reported significant improvements in upper limb function. However, the robot in the latter study focused on single-plane distal movements only and long-term effects of the tDCS were not assessed. Recent robotic developments included robots with three rotational degrees-of-freedom for the upper limb, but the effectiveness of this type of robot combined with tDCS in early stroke settings is unknown. Ethical Approval was sought from NHS NRES Committee South Central- Southampton B (Ref: 11/SC/0345) to conduct this study.
- Conditions
- Stroke
- Being tested
- Robot therapy and transcranial direct current stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot therapy and transcranial direct current stimulationDevice
Administration of Robot Therapy:
Therapy will be administered by making use of the Armeo Robot. Sessions will involve high-intensity, repetitive, task-oriented movements directed by video screens. Administration of tDCS:
Anodal tDCS will be administered using a CE marked transcranial Direct Current Stimulator (Newronika Italy). Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35 cm2).
| Study group | Role | What they receive |
|---|---|---|
| Robot Therapy and Real Transcranial Direct Current Stimulation | Experimental | This group will involve carrying out robot therapy and real transcranial Direct Current Stimulation (tDCS). Receives: Device: Robot therapy and transcranial direct current stimulation |
| Robot Therapy and sham tDCS | Placebo comparator | Participants will be randomised to group 2 whereby they will carry out the same robot therapy programme however, receiving sham stimulation. Receives: Device: Robot therapy and transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Report change in upper limb function from baseline to 8 weeks and 3 months after treatment
Measures sensorimotor function of the upper limb (Sanford et al. 1993; Fugl-Meyer et al. 1975)
Measured: Will be used, exactly before commencing training programme (day 1), at the end of the 8 week training programme and at 3 months follow-up
Secondary outcomes (1)
Report change in cortical excitability from baseline to 8 weeks and 3 months after treatment
Corticospinal excitability will be measured by the administration of focal TMS using a figure-of-eight coil to the M1 area of the affected hemisphere. The 'hot spot' will be established by using neuronavigation equipment called Brain Sight (Rogue Research Inc.). The amplitude of the MEPs and recruitment curve of the anterior deltoid (proximal muscle) and extensor digitorum communis (distal muscle) will be subsequently recorded using electromyography.
Measured: Will be used, exactly before commencing training programme (day 1), at the end of the 8 week training programme and at 3 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 posted29 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Principal investigator, Jane Burridge, PhD, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405378
- Sponsor's protocol ID
- Wessex Innovative Grant P09
- Status last verified
- Jun 2016
- First submitted
- 21 Jul 2011
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Transcranial Direct Current Stimulation (tDCS) With Robot Therapy for the Impaired Upper Limb in Stroke Rehabilitation.
- ClinicalTrials.gov ID
- NCT01405378
- Acronym / sponsor ID
- Wessex Innovative Grant P09
- Conditions
- Stroke
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- Oct 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Jul 2011 (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.
Every five minutes someone in the UK has a stroke. It is the main cause of long-term disability among adults in the UK despite a fall in age-specific stroke incidence, with a growing number of survivors remaining dependent for activities of daily living. While most people with stroke regain walking ability, upper limb problems with no voluntary arm and hand activity, affecting a third of people after stroke, has a poor prognosis. Transcranial direct current stimulation (tDCS) is a non-invasive procedure used to polarise brain regions through the application of weak direct currents and has the potential to develop into a useful aid to treatment strategies in neurorehabilitation. Recent literature into the application of tDCS in people with arm and hand impairments after stroke has shown promising results on upper limb function measures like the Jebsen-Taylor hand function test. Furthermore, a recent pilot study evaluated a six-week training programme combining tDCS with robot-assisted hand training and reported significant improvements in upper limb function. However, the robot in the latter study focused on single-plane distal movements only and long-term effects of the tDCS were not assessed. Recent robotic developments included robots with three rotational degrees-of-freedom for the upper limb, but the effectiveness of this type of robot combined with tDCS in early stroke settings is unknown. Ethical Approval was sought from NHS NRES Committee South Central- Southampton B (Ref: 11/SC/0345) to conduct this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot Therapy and Real Transcranial Direct Current Stimulation | Experimental | Device: Robot therapy and transcranial direct current stimulationThis group will involve carrying out robot therapy and real transcranial Direct Current Stimulation (tDCS). |
| Robot Therapy and sham tDCS | Placebo comparator | Device: Robot therapy and transcranial direct current stimulationParticipants will be randomised to group 2 whereby they will carry out the same robot therapy programme however, receiving sham stimulation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have a confirmed clinical diagnosis of a haemorrhagic or an ischaemic stroke confirmed clinically or by CT, PET or MRI Scan
- Experienced a single (first) stroke or multiple strokes
- In the acute, sub-acute or chronic phase of their recovery (the first three to seven days are referred to as the acute phase. The first two weeks to six months are defined as the sub-acute phase, and the chronic phase begins after three or six months (Teismann et al. 2011, Duncan et al. 2003a)
- Have had a subcortical or cortical stroke
- Be over the age of 18 years
Key exclusion criteria (5 listed)
- A history of epilepsy (TMS studies) due to the fact that TMS could cause an epileptic fit
- Impaired gross cognitive function; score of less than 24 of the Mini-Mental State Examination (Folstein et al. 1975)
- Any metal implants in the head including cochlear implants
- Any another neurological condition apart from stroke
- Are currently participants in another intervention study using TMS/tDCS
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 |
|---|---|---|
| Robot therapy and transcranial direct current stimulationAdministration of Robot Therapy: Therapy will be administered by making use of the Armeo Robot. Sessions will involve high-intensity, repetitive, task-oriented movements directed by video screens. Administration of tDCS: Anodal tDCS will be administered using a CE marked transcranial Direct Current Stimulator (Newronika Italy). Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35 cm2). | Device | Robot Therapy and Real Transcranial Direct Current Stimulation, Robot Therapy and sham tDCS |
Primary outcome
Report change in upper limb function from baseline to 8 weeks and 3 months after treatment
Time frame: Will be used, exactly before commencing training programme (day 1), at the end of the 8 week training programme and at 3 months follow-up
Measures sensorimotor function of the upper limb (Sanford et al. 1993; Fugl-Meyer et al. 1975)
1 secondary outcome
Report change in cortical excitability from baseline to 8 weeks and 3 months after treatment
Time frame: Will be used, exactly before commencing training programme (day 1), at the end of the 8 week training programme and at 3 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 Jun 2016.
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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 Early Phase 1 study testing Robot therapy and transcranial direct current stimulation in people with Stroke, run by University of Southampton at 1 site in United Kingdom.
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 6 inclusion and 5 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 Jun 2016. 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 Kingdom. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Report change in upper limb function from baseline to 8 weeks and 3 months after treatment (time frame: Will be used, exactly before commencing training programme (day 1), at the end of the 8 week training programme and at 3 months follow-up). 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 23 Jun 2016.