Transcranial Magnetic StimulationPhase 1NCT06164912
Investigating the Use of a Brain-computer Interface Based on TMS Neurofeedback for Upper Limb Stroke Rehabilitation
A Phase 1 study testing Transcranial Magnetic Simulation with Pseudofeedback and Transcranial Magnetic Simulation with Neurofeedback in people with Transcranial Magnetic Stimulation and Stroke, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
The mechanisms and effectiveness of a technique to boost the brain's recovery mechanisms will be studied. Brain-Computer Interface (BCI),based on applying magnetic pulses (Transcranial Magnetic Stimulation, TMS) to the stroke damaged area in the brain, causing twitches in the paralysed muscles will be used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcranial Magnetic Stimulation, Stroke, Stroke Rehabilitation
- What is being tested?
- Transcranial Magnetic Simulation with Pseudofeedback and Transcranial Magnetic Simulation with Neurofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 1 Jun 2023to Aug 2025
- Phase
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be in the sub-acute phase (2-26 weeks) post stroke.
- Single hemisphere lesion
- No previous transient ischemic attack (TIA)
- Upper limb functional impairment (0-2 power)
- No or negligible OCS broken hearts test score (visual neglect)
- No or almost no cognitive impairment (Pass or near pass MMSE and MOCA)
Show all 25Show fewer
- Passes TMS-Safety Questionnaire
- Detectable motor evoked potential (MEP) in response to TMS
- The exclusion criteria include:
- History of neuromuscular, neurological or active psychiatric disease (as these conditions and their respective medications may influence corticomotor excitability).
- History of epilepsy or risk of reduced seizure threshold. There is a small remote risk of seizure associated with high-frequency repetitive TMS, which is NOT used in the current protocol. This study uses classical protocols and parameters that fall within the safety limits reported by Rossi et al (2009). Therefore this exclusion criteria is purely an additional precaution.
- Presence of metallic implants in the head. The sole absolute contraindication to TMS is the presence of metallic implants near to the discharging coils. Exclusion is to avoid risk of heating, malfunction in the implanted device, or cause seizure.
- History of anxiety-induced fainting. Patients with a history of anxiety induced fainting are at a small risk of fainting due to taking part in the study or hearing the 'clicking' sound produced by the TMS coil discharging.
- History of reaction or allergy to equipment or the skin preparation gel used to clean the skin surface prior to placing EMG electrodes. While allergic reaction to any of the materials used us very unlikely, any participants with history of adverse reaction to the environments or materials used (or similar) will be excluded to protect their wellbeing and prevent distress.
- Use of illicit drugs or other neurotransmission-altering drugs. These influence the brain and hence may impact upon the TMS or MRI measurements.
- Consumption of alcohol on the night preceding the recordings- to avoid potential influence of residual alcohol on neural network activity.
- Insufficient sleep on the night preceding the recording to prevent participants falling asleep or dozing during the recording, which would influence task performance. This is also in keeping with the guidelines of Rossi et al (2009).
- Eating very little in the 6 hours preceding the study- to avoid weakness or faintness.
- Any medical condition associated with neuropathy (eg.diabetes), seizure disorder, brain tumours, structural brain diseases, other degenerative brain diseases and other comorbidities (e.g human immunodeficiency virus). This is to prevent abnormal neural activity generating data related to something other than that of the diagnosis under study (stroke).
- Any head trauma injury associated with loss of consciousness.
- Regular, severe headaches
- Noise induced hearing loss, or ringing in the ears.
- Possible pregnancy
- Implanted Neurostimulator
- Anxiety in Hospital settings
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
St James' Hospital
Dublin, Leinster, D08 NHY1
Jow Harbison, MD, jharbison@stjames.ie
About this study
The mechanisms and effectiveness of a technique to boost the brain's recovery mechanisms will be studied. Brain-Computer Interface (BCI),based on applying magnetic pulses (Transcranial Magnetic Stimulation, TMS) to the stroke damaged area in the brain, causing twitches in the paralysed muscles will be used. The size of these twitches are then displayed to the patient as neurofeedback (NF) on a computer screen in the form of a game. In the game, the aim for the patient is to learn how to make the twitches bigger by engaging appropriate mental imagery to re-activate the damaged brain region.
Read the detailed description
Participants will undergo transcranial magnetic stimulation (TMS) neurofeedback (NF) incorporated into a computer game that is tailored to train the individuals to produce larger than baseline motor evoked potentials (MEPs) in the stroke affected limb, by practising different mental imagery strategies. Pulses of TMS will be applied over the motor cortex of the stroke affected hemisphere, resulting in MEPs that will be recorded from the target muscles of the stroke affected limb. The brain computer interface (BCI) will process the amplitude of these MEPs in real-time, and will display this information on screen to the patient in the form of a game, where their goal is to push a rectangular bar (MEP amplitude) over the line (baseline amplitude when resting). If the trial is successful, the bar turns green and a positive sound-bite is heard. If unsuccessful, the bar turns red and a negative sound-bite is heard. This procedure is repeated for a total of 60 trials per session, spread over three distinct blocks with rest breaks in between. Changes in MEP amplitude will be monitored as training progresses. Half of the participants will be randomly allocated to a control condition, whereby they will experience identical TMS procedures as the experimental group apart from that the feedback bar height on screen will not display MEP amplitude, but will be fixed in the middle of the screen. Positive and negative feedback will be delivered, but in a fixed pattern, not related to changes in MEP.
Functional upper limb tests and qualitative tests will be conducted before TMS NF training starts and at the end of the training. Tools: Fugl-Myer (FM), Action Research Arm Test (ARAT), Oxford Cognitive Screen (OCS), National Institutes of Health Stroke Severity Scale (NIHSS), Muscle circumference (Bicep and forearm), Sleep Questionnaire, Hospital Anxiety and Depression Scale (HADS), Mental imagery questionnaire (MIQ). Brain MRI datasets from patients collected before and after TMS NF training. There will be 2 distinct data types produced: 1. High resolution T1 anatomical scans (grey matter) 2. Diffusion weighted imaging (DWI) scans (white matter).
Objectives are:
- Increasing the 'excitability' of the pathways connecting the brain to the muscles of the paralysed arm and hand in stroke patients. This is measurable via motor-evoked potentials (MEPs) in response to TMS.
- To reduce upper limb functional disabilities in sub-acute patients (2-26 weeks post stroke) further and within a faster time scale than standard care approaches.
- To investigate the mechanisms leading to increased excitability and better motor function.
- To describe the patient perspective of TMS NF as an add-on to their standard stroke rehabilitative care. The aim is to measure qualitatively the patient's experience during the training and record their subjective perceived benefits via interview.
- To quantify the extent to which benefits derived from TMS NF training generalise beyond the motor domain, to influence mood and aspects of cognition.
- To describe the functional and structural brain mechanisms that underlay improvements in upper limb motor function due to the self-regulation of cortico-spinal excitability using TMS NF.
- Being tested
- Transcranial Magnetic Simulation with Pseudofeedback, Transcranial Magnetic Simulation with Neurofeedback
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Simulation with PseudofeedbackOther
Participants will receive TMS with bogus feedback that will be displayed on a screen as they imagine movement.
Transcranial Magnetic Simulation with NeurofeedbackOther
Participants will receive TMS with live Neurofeedback that will be displayed on a screen for them as they are imagining movement
| Study group | Role | What they receive |
|---|---|---|
| TMS Neurofeedback | Active comparator | Participants in this Arm will receive TMS neurofeedback Receives: Other: Transcranial Magnetic Simulation with Neurofeedback |
| TMS Pseudofeedback | Placebo comparator | Participants in this Arm will receive TMS with pseudofeedback Receives: Other: Transcranial Magnetic Simulation with Pseudofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer
assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.
Measured: pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.
The National Institutes of Health Stroke Scale
to measure stroke-related neurological deficit.The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible
Measured: pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.
Action research arm test
assess upper extremity performance (coordination, dexterity and functioning). Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.
Measured: pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.
Oxford Cognitive Screen
assess Language, Praxis, Number, Memory, Spatial and Controlled Attention. Each domain is scored separately and has a specific total.
Measured: pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.
Sleep questionnaire
28 items. Four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always"
Measured: pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.
Mental imagery questionnaire
2 items. 5-point, Likert-type scale, respondents indicate how vivid their visual and kinesthetic motor imagery is. Visual: 5 - image as clear as seeing,4 - clear image,3 -moderately clear image 2 - blurred image,1 - no image.
Kinesthetic - How well can you feel opening and closing your paretic hand? 5 - as intense as executing the action, 4 - intense 3 - moderately intense, 2 - mildly intense
1 - no sensation.
Measured: pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.
Grey matter MRI Scan
High-Resolution T1 Anatomical Scans (Grey matter) which will show concentration of tissue with high fat content (grey matter) to demonstrate brain anatomy. We will see if there are any structural brain changes before and after the TMS intervention.
Measured: Baseline pre beginning TMS sessions. 6 months post last TMS sessions
White matter MRI scan
Diffusion Tensor Imaging Scans for imaging the concentration of white matter of the brain. We will see if there are any structural brain changes before and after the TMS intervention.
Measured: Baseline pre beginning TMS sessions. 6 months post last TMS sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jun 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transcranial Magnetic StimulationStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will undergo transcranial magnetic stimulation (TMS) neurofeedback (NF) incorporated into a computer game that is tailored to train the individuals to produce larger than baseline motor evoked potentials (MEPs) in the stroke affected limb, by practising and engaging different mental imagery strategies. Pulses of TMS will be applied over the motor cortex of the stroke affected hemisphere, resulting in MEPs that will be recorded from the target muscles of the stroke affected limb.The brain computer interface (BCI) will process the amplitude of these MEPs in real-time, and will display this information on screen to the patient in the form of a game, where their goal is to push a rectangular bar (MEP amplitude) over the line (baseline amplitude when resting).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Collaborators
- St. James Hospital
- Responsible party
- Principal investigator, Lamia Tadjine, University of Dublin, Trinity College
- Investigators
- Joe Harbison, MD, Study director, St. James' Hospital Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164912
- Sponsor's protocol ID
- HRB-EIA-2019-003
- Status last verified
- Dec 2023
- First submitted
- 24 Oct 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Byblow WD, Stinear CM, Barber PA, Petoe MA, Ackerley SJ. Proportional recovery after stroke depends on corticomotor integrity. Ann Neurol. 2015 Dec;78(6):848-59. doi: 10.1002/ana.24472. Epub 2015 Nov 17.
PubMed 26150318Ruddy K, Balsters J, Mantini D, Liu Q, Kassraian-Fard P, Enz N, Mihelj E, Subhash Chander B, Soekadar SR, Wenderoth N. Neural activity related to volitional regulation of cortical excitability. Elife. 2018 Nov 29;7:e40843. doi: 10.7554/eLife.40843.
PubMed 30489255Liang WD, Xu Y, Schmidt J, Zhang LX, Ruddy KL. Upregulating excitability of corticospinal pathways in stroke patients using TMS neurofeedback; A pilot study. Neuroimage Clin. 2020;28:102465. doi: 10.1016/j.nicl.2020.102465. Epub 2020 Oct 13.
PubMed 33395961
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Use of a Brain-computer Interface Based on TMS Neurofeedback for Upper Limb Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT06164912
- Acronym / sponsor ID
- HRB-EIA-2019-003
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Collaborators
- St. James Hospital
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 11 Dec 2023 (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 mechanisms and effectiveness of a technique to boost the brain's recovery mechanisms will be studied. Brain-Computer Interface (BCI),based on applying magnetic pulses (Transcranial Magnetic Stimulation, TMS) to the stroke damaged area in the brain, causing twitches in the paralysed muscles will be used. The size of these twitches are then displayed to the patient as neurofeedback (NF) on a computer screen in the form of a game. In the game, the aim for the patient is to learn how to make the twitches bigger by engaging appropriate mental imagery to re-activate the damaged brain region.
Detailed description
Participants will undergo transcranial magnetic stimulation (TMS) neurofeedback (NF) incorporated into a computer game that is tailored to train the individuals to produce larger than baseline motor evoked potentials (MEPs) in the stroke affected limb, by practising different mental imagery strategies. Pulses of TMS will be applied over the motor cortex of the stroke affected hemisphere, resulting in MEPs that will be recorded from the target muscles of the stroke affected limb. The brain computer interface (BCI) will process the amplitude of these MEPs in real-time, and will display this information on screen to the patient in the form of a game, where their goal is to push a rectangular bar (MEP amplitude) over the line (baseline amplitude when resting). If the trial is successful, the bar turns green and a positive sound-bite is heard. If unsuccessful, the bar turns red and a negative sound-bite is heard. This procedure is repeated for a total of 60 trials per session, spread over three distinct blocks with rest breaks in between. Changes in MEP amplitude will be monitored as training progresses. Half of the participants will be randomly allocated to a control condition, whereby they will experience identical TMS procedures as the experimental group apart from that the feedback bar height on screen will not display MEP amplitude, but will be fixed in the middle of the screen. Positive and negative feedback will be delivered, but in a fixed pattern, not related to changes in MEP.
Functional upper limb tests and qualitative tests will be conducted before TMS NF training starts and at the end of the training. Tools: Fugl-Myer (FM), Action Research Arm Test (ARAT), Oxford Cognitive Screen (OCS), National Institutes of Health Stroke Severity Scale (NIHSS), Muscle circumference (Bicep and forearm), Sleep Questionnaire, Hospital Anxiety and Depression Scale (HADS), Mental imagery questionnaire (MIQ). Brain MRI datasets from patients collected before and after TMS NF training. There will be 2 distinct data types produced: 1. High resolution T1 anatomical scans (grey matter) 2. Diffusion weighted imaging (DWI) scans (white matter).
Objectives are:
- Increasing the 'excitability' of the pathways connecting the brain to the muscles of the paralysed arm and hand in stroke patients. This is measurable via motor-evoked potentials (MEPs) in response to TMS.
- To reduce upper limb functional disabilities in sub-acute patients (2-26 weeks post stroke) further and within a faster time scale than standard care approaches.
- To investigate the mechanisms leading to increased excitability and better motor function.
- To describe the patient perspective of TMS NF as an add-on to their standard stroke rehabilitative care. The aim is to measure qualitatively the patient's experience during the training and record their subjective perceived benefits via interview.
- To quantify the extent to which benefits derived from TMS NF training generalise beyond the motor domain, to influence mood and aspects of cognition.
- To describe the functional and structural brain mechanisms that underlay improvements in upper limb motor function due to the self-regulation of cortico-spinal excitability using TMS NF.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will undergo transcranial magnetic stimulation (TMS) neurofeedback (NF) incorporated into a computer game that is tailored to train the individuals to produce larger than baseline motor evoked potentials (MEPs) in the stroke affected limb, by practising and engaging different mental imagery strategies. Pulses of TMS will be applied over the motor cortex of the stroke affected hemisphere, resulting in MEPs that will be recorded from the target muscles of the stroke affected limb.The brain computer interface (BCI) will process the amplitude of these MEPs in real-time, and will display this information on screen to the patient in the form of a game, where their goal is to push a rectangular bar (MEP amplitude) over the line (baseline amplitude when resting).
| Arm | Type | Receives |
|---|---|---|
| TMS Neurofeedback | Active comparator | Other: Transcranial Magnetic Simulation with NeurofeedbackParticipants in this Arm will receive TMS neurofeedback |
| TMS Pseudofeedback | Placebo comparator | Other: Transcranial Magnetic Simulation with PseudofeedbackParticipants in this Arm will receive TMS with pseudofeedback |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Be in the sub-acute phase (2-26 weeks) post stroke.
- Single hemisphere lesion
- No previous transient ischemic attack (TIA)
- Upper limb functional impairment (0-2 power)
- No or negligible OCS broken hearts test score (visual neglect)
Key exclusion criteria (0 listed)
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 Magnetic Simulation with PseudofeedbackParticipants will receive TMS with bogus feedback that will be displayed on a screen as they imagine movement. | Other | TMS Pseudofeedback |
| Transcranial Magnetic Simulation with NeurofeedbackParticipants will receive TMS with live Neurofeedback that will be displayed on a screen for them as they are imagining movement | Other | TMS Neurofeedback |
Primary outcome
Fugl Meyer
Time frame: pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.
assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.
The National Institutes of Health Stroke Scale
Time frame: pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.
to measure stroke-related neurological deficit.The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible
Action research arm test
Time frame: pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.
assess upper extremity performance (coordination, dexterity and functioning). Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.
Oxford Cognitive Screen
Time frame: pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.
assess Language, Praxis, Number, Memory, Spatial and Controlled Attention. Each domain is scored separately and has a specific total.
Sleep questionnaire
Time frame: pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.
28 items. Four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always"
Mental imagery questionnaire
Time frame: pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.
2 items. 5-point, Likert-type scale, respondents indicate how vivid their visual and kinesthetic motor imagery is. Visual: 5 - image as clear as seeing,4 - clear image,3 -moderately clear image 2 - blurred image,1 - no image. Kinesthetic - How well can you feel opening and closing your paretic hand? 5 - as intense as executing the action, 4 - intense 3 - moderately intense, 2 - mildly intense 1 - no sensation.
Grey matter MRI Scan
Time frame: Baseline pre beginning TMS sessions. 6 months post last TMS sessions
High-Resolution T1 Anatomical Scans (Grey matter) which will show concentration of tissue with high fat content (grey matter) to demonstrate brain anatomy. We will see if there are any structural brain changes before and after the TMS intervention.
White matter MRI scan
Time frame: Baseline pre beginning TMS sessions. 6 months post last TMS sessions
Diffusion Tensor Imaging Scans for imaging the concentration of white matter of the brain. We will see if there are any structural brain changes before and after the TMS intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Results publication: PubMed 26150318Byblow WD, Stinear CM, Barber PA, Petoe MA, Ackerley SJ. Proportional recovery after stroke depends on corticomotor integrity. Ann Neurol. 2015 Dec;78(6):848-59. doi: 10.1002/ana.24472. Epub 2015 Nov 17.
- Results publication: PubMed 30489255Ruddy K, Balsters J, Mantini D, Liu Q, Kassraian-Fard P, Enz N, Mihelj E, Subhash Chander B, Soekadar SR, Wenderoth N. Neural activity related to volitional regulation of cortical excitability. Elife. 2018 Nov 29;7:e40843. doi: 10.7554/eLife.40843.
- Results publication: PubMed 33395961Liang WD, Xu Y, Schmidt J, Zhang LX, Ruddy KL. Upregulating excitability of corticospinal pathways in stroke patients using TMS neurofeedback; A pilot study. Neuroimage Clin. 2020;28:102465. doi: 10.1016/j.nicl.2020.102465. Epub 2020 Oct 13.
- Individual participant dataSharing planned: No
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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.
Joe Harbison, MD study director
St. James' Hospital Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transcranial Magnetic Simulation with Pseudofeedback and Transcranial Magnetic Simulation with Neurofeedback in people with Transcranial Magnetic Stimulation and Stroke, run by University of Dublin, Trinity College at 1 site in Ireland.
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 25 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 11 Dec 2023. 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 Ireland. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathy Ruddy, PhD (+44 7481811676, k.ruddy@qub.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl Meyer (time frame: pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.). The study lists 8 primary outcomes in all. 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 NCT06164912, which also lists 3 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 11 Dec 2023.