Oropharyngeal DysphagiaNCT03274947
The Utility of Cerebellar Transcranial Magnetic Stimulation in the Neurorehabilitation of Dysphagia After Stroke
A study testing Cerebellar TMS in people with Oropharyngeal Dysphagia and Stroke, run by University of Manchester at 2 sites in United Kingdom.
Trial summary
The study is designed to explore the effectiveness of non-invasive cerebellar stimulation to enhance motor plasticity in the cortex after stroke. The investigators have shown that the human cerebellum is strongly activated during the act of swallowing and when stimulated with single TMS pulses can strongly facilitate… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oropharyngeal Dysphagia, Stroke
- What is being tested?
- Cerebellar TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 14 Jan 2019to 31 Oct 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and over
- All patients with an acute anterior or posterior cerebral circulation stroke within 6 weeks of symptom onset.
Who cannot join
- Advanced dementia
- Previous history of dysphagia
- Patients judged to be clinically unstable
- Presence of implanted cardiac pacemaker or defibrillator
- Any severe chronic medical condition that compromises cardiac or respiratory status
- Patients with acute lower respiratory tract infections requiring antibiotic treatment.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Upper G.I laboratory, Salford Royal Hospital
Manchester, Greater Manchester, M6 8HD
Stroke Unit, Nottingham University Hospitals
Nottingham, Notthinghamshire
About this study
Official title: An Exploration of the Application of Non-invasive Cerebellar Stimulation in the Neurorehabilitation of Dysphagia After Stroke
The study is designed to explore the effectiveness of non-invasive cerebellar stimulation to enhance motor plasticity in the cortex after stroke. The investigators have shown that the human cerebellum is strongly activated during the act of swallowing and when stimulated with single TMS pulses can strongly facilitate the corticobulbar projection to the pharynx in humans. More recently the investigators have identified the most relevant frequency of stimulation of the cerebellum that can produce longer term excitation in the human swallowing motor system. The investigators therefore believe that the potential for cerebellar stimulation in improving swallowing is much greater than other methods for two reasons. Firstly, previous work has shown that unlike successful recovery of hand/arm function which relies on restoring activity in the stroke hemisphere, recovery of swallowing function relies on increased excitability in intact projections from the non-stroke hemisphere. The investigators believe that methods that can enhance these undamaged pathways have a greater chance of inducing recovery in the human swallowing system in unilateral stroke. Additionally cerebellar stimulation produces very high levels of corticobulbar excitation it may also have the advantage of improving dysphagia in posterior fossa strokes. Second, the human cerebellum is relatively easy to target and stimulate and has reduced risk of inducing unwanted effects (such as seizures) which as a consequence makes cerebellar stimulation a more pragmatic method for delivering therapeutic neurorehabilitation to dysphagic stroke patients compared to other more complex/riskier methods.
A final factor is that the investigators have developed a "virtual lesion" model of swallowing dysfunction in healthy volunteers which can be reversed quite successfully with other neuro-stimulation protocols. The investigators can therefore use this model to test the effectiveness of cerebellar stimulation protocols (ipsilateral and contralateral cerebellar sites) before choosing the most effective side to apply stimulation in a proof of principle trial/study in a small group of sub-acute dysphagic patients.
Read more
The hypotheses are that cerebellar TMS will:
- Reverse the brain inhibition and behavioural dysfunction following a virtual lesion model of disrupted swallowing in healthy brain (phase 1); ii. Reduce the degree of aspiration in acute dysphagia after a stroke (phase 2).
Read the detailed description
Protocols:
Hypothesis 1:
Cortical excitability (in both dominant and non-dominant swallowing cortex) to TMS and swallowing behaviour assessed with a swallowing reaction time task will be measured at baseline. Thereafter, the virtual lesion paradigm will be applied to the dominant swallowing projection followed by the cerebellar intervention (10Hz, 250 pulses). Cerebellar stimulation will be applied (in a randomised fashion) on separate occasions to both the contralateral and ipsilateral cerebellar hemispheres, immediately after the virtual lesion. The investigators have found that placement using known reference landmarks are equivalent to using neuronavigation, so the latter will not be employed. Repeat measurements of cortical excitability and swallowing behaviour will then be performed and analysed against baseline data and a sham cerebellar paradigm. Differences in cortical excitability and swallowing responses will thus be an indication of which cerebellar region (contralesional/ipsilesional) can influence excitability and reverse any behavioural changes most effectively.
Hypothesis 2:
- Dysphagic stroke patients (n=24) recruited over a 9 month period within 14 days of stroke ictus will have their swallowing assessed by videofluoroscopy before and after receiving either the real or sham cerebellar stimulation (10Hz, 250 pulses) as determined from phase 1. As before, placement of the coil for cerebellar stimulation will be performed using landmarks already established and validated in the work from question 1. Patients will be intubated with the pharyngeal EMG catheter for pre and post recordings of pharyngeal motor evoked potentials (MEPs) to cortical TMS. Power calculations, based on a similar study of pharyngeal stimulation indicated that the investigators would need 12 patients per group to achieve a statistical power of 80% at a 5% significance level to detect changes in the primary outcome measure of aspiration. In this study, the investigators will examine if the chosen site of cerebellar stimulation from phase 1 can induce short-term changes in brain function (pharyngeal MEPs) and swallowing function (videofluoroscopy) compared to sham interventions and baseline measurement, up to 1 hour after the intervention.
II. Following stage I, once it is established that cerebellar stimulation can alter brain and swallowing functions in stroke in the short-term, it will need to be appraised for clinical feasibility, dose response, and longer term efficacy. Dysphagic stroke patients (n=48, 16 patients per group) admitted to the stroke unit and identified by videofluoroscopy will be recruited over the next 21 months. Since it is not known how the cerebellar stimulation method should be delivered to patients, a dose ranging treatment trial will be utilised, randomising patients to one of three groups (A-C), low level stimulation, high level stimulation and sham stimulation. From our previous work with pharyngeal stimulation, the investigators propose that group A will receive stimulation once per day for 3 days. Group B will receive stimulation twice per day for 5 days. Group C will receive sham stimulation (delivered as in protocol I) twice a day for 5 days. Groups A and B will receive stimulation at the optimal site (10Hz, 250 pulses) found in question 1, but all groups will also receive standard speech and language therapy.
Assessments:
Swallowing before and after stimulation will be evaluated using videofluoroscopy, at 1 hour for protocol I. For protocol II the investigators propose both videofluoroscopy and functional scores (Functional oral ingestion scale (FOIS), the dysphagia severity rating scale (DSRS) including feeding status and modified rankin scale (mRS)) at baseline and at 2 weeks.
- Conditions
- Oropharyngeal Dysphagia, Stroke
- Being tested
- Cerebellar TMS, Sham cerebellar TMS
- Keywords
- Oropharyngeal Dysphagia, Stroke
- Medical subject headings
- Deglutition Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebellar TMSDevice
Cerebellar transcranial magnetic stimulation
Sham cerebellar TMSDevice
Sham cerebellar transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| Hypothesis 2 Protocol 2 Low dose TMS | Active comparator | Low level cerebellar TMS. Delivered once per day for 3 days. Receives: Device: Cerebellar TMS |
| Hypothesis 2 Protocol 2 High dose TMS | Active comparator | High level cerebellar TMS. Delivered twice per day for 5 days. Receives: Device: Cerebellar TMS |
| Hypothesis 2 Protocol 2 Sham | Sham comparator | Sham cerebellar TMS. Delivered twice a day for 5 days. Receives: Device: Sham cerebellar TMS |
| Hypothesis 2 Protocol 1 Cerebellar TMS | Active comparator | Cerebellar TMS at 10Hz, 250 pulses. Receives: Device: Cerebellar TMS |
| Hypothesis 2 Protocol 1 Sham | Sham comparator | Sham cerebellar TMS Receives: Device: Sham cerebellar TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penetration aspiration scores on videofluoroscopy (number of swallows out of 6 that score 3 or more on the penetration aspiration scale) (Hypothesis 2 protocols 1 and 2)
Penetration aspiration scores on videofluoroscopy (number of swallows out of 6 that score 3 or more on the penetration aspiration scale)
Measured: 1 hour post intervention and 2 weeks post intervention
Secondary outcomes (1)
Improvement of: Functional oral ingestion scale (FOIS) and or the dysphagia severity rating scale (DSRS) (Hypothesis 2 protocol 2)
Improvement of: Functional oral ingestion scale (FOIS) and or the dysphagia severity rating scale (DSRS)
Measured: 2 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start14 Jan 2019
- Primary completion30 Jun 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, University of Nottingham
- Responsible party
- Principal investigator, Prof Shaheen Hamdy PhD FRCP, University of Manchester
- Investigators
- Shaheen Hamdy, MBChB, PhD, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274947
- Sponsor's protocol ID
- 5111 protocol ver1
- Status last verified
- Nov 2022
- First submitted
- 14 Aug 2017
- Last updated
- 1 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No identifiable individual participant information will be shared outside the immediate research team. However, identifiable individual participant information will be made available to the Medical research council and the University of Manchester if required for the purposes of auditing the study.
Publications
Smithard DG, O'Neill PA, Parks C, Morris J. Complications and outcome after acute stroke. Does dysphagia matter? Stroke. 1996 Jul;27(7):1200-4. doi: 10.1161/01.str.27.7.1200.
PubMed 8685928Geeganage C, Beavan J, Ellender S, Bath PM. Interventions for dysphagia and nutritional support in acute and subacute stroke. Cochrane Database Syst Rev. 2012 Oct 17;10:CD000323. doi: 10.1002/14651858.CD000323.pub2.
PubMed 23076886Finucane TE, Bynum JP. Use of tube feeding to prevent aspiration pneumonia. Lancet. 1996 Nov 23;348(9039):1421-4. doi: 10.1016/S0140-6736(96)03369-7. No abstract available.
PubMed 8937283Machado AG, Baker KB, Schuster D, Butler RS, Rezai A. Chronic electrical stimulation of the contralesional lateral cerebellar nucleus enhances recovery of motor function after cerebral ischemia in rats. Brain Res. 2009 Jul 14;1280:107-16. doi: 10.1016/j.brainres.2009.05.007. Epub 2009 May 12.
PubMed 19445910Park HJ, Furmaga H, Cooperrider J, Gale JT, Baker KB, Machado AG. Modulation of Cortical Motor Evoked Potential After Stroke During Electrical Stimulation of the Lateral Cerebellar Nucleus. Brain Stimul. 2015 Nov-Dec;8(6):1043-8. doi: 10.1016/j.brs.2015.06.020. Epub 2015 Jul 8.
PubMed 26215752Hamdy S, Rothwell JC, Brooks DJ, Bailey D, Aziz Q, Thompson DG. Identification of the cerebral loci processing human swallowing with H2(15)O PET activation. J Neurophysiol. 1999 Apr;81(4):1917-26. doi: 10.1152/jn.1999.81.4.1917.
PubMed 10200226Jayasekeran V, Rothwell J, Hamdy S. Non-invasive magnetic stimulation of the human cerebellum facilitates cortico-bulbar projections in the swallowing motor system. Neurogastroenterol Motil. 2011 Sep;23(9):831-e341. doi: 10.1111/j.1365-2982.2011.01747.x.
PubMed 21838728Vasant DH, Michou E, Mistry S, Rothwell JC, Hamdy S. High-frequency focal repetitive cerebellar stimulation induces prolonged increases in human pharyngeal motor cortex excitability. J Physiol. 2015 Nov 15;593(22):4963-77. doi: 10.1113/JP270817. Epub 2015 Sep 30.
PubMed 26316351Mistry S, Verin E, Singh S, Jefferson S, Rothwell JC, Thompson DG, Hamdy S. Unilateral suppression of pharyngeal motor cortex to repetitive transcranial magnetic stimulation reveals functional asymmetry in the hemispheric projections to human swallowing. J Physiol. 2007 Dec 1;585(Pt 2):525-38. doi: 10.1113/jphysiol.2007.144592. Epub 2007 Oct 11.
PubMed 17932140Hamdy S, Rothwell JC. Gut feelings about recovery after stroke: the organization and reorganization of human swallowing motor cortex. Trends Neurosci. 1998 Jul;21(7):278-82. doi: 10.1016/s0166-2236(97)01212-5.
PubMed 9683316Hamdy S, Aziz Q, Rothwell JC, Singh KD, Barlow J, Hughes DG, Tallis RC, Thompson DG. The cortical topography of human swallowing musculature in health and disease. Nat Med. 1996 Nov;2(11):1217-24. doi: 10.1038/nm1196-1217.
PubMed 8898748Hamdy S, Mikulis DJ, Crawley A, Xue S, Lau H, Henry S, Diamant NE. Cortical activation during human volitional swallowing: an event-related fMRI study. Am J Physiol. 1999 Jul;277(1):G219-25. doi: 10.1152/ajpgi.1999.277.1.G219.
PubMed 10409170Hamdy S, Aziz Q, Rothwell JC, Power M, Singh KD, Nicholson DA, Tallis RC, Thompson DG. Recovery of swallowing after dysphagic stroke relates to functional reorganization in the intact motor cortex. Gastroenterology. 1998 Nov;115(5):1104-12. doi: 10.1016/s0016-5085(98)70081-2.
PubMed 9797365Hamdy S, Rothwell JC, Aziz Q, Singh KD, Thompson DG. Long-term reorganization of human motor cortex driven by short-term sensory stimulation. Nat Neurosci. 1998 May;1(1):64-8. doi: 10.1038/264.
PubMed 10195111Fraser C, Power M, Hamdy S, Rothwell J, Hobday D, Hollander I, Tyrell P, Hobson A, Williams S, Thompson D. Driving plasticity in human adult motor cortex is associated with improved motor function after brain injury. Neuron. 2002 May 30;34(5):831-40. doi: 10.1016/s0896-6273(02)00705-5.
PubMed 12062028
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploration of the Application of Non-invasive Cerebellar Stimulation in the Neurorehabilitation of Dysphagia After Stroke
- ClinicalTrials.gov ID
- NCT03274947
- Acronym / sponsor ID
- 5111 protocol ver1
- Conditions
- Oropharyngeal Dysphagia, Stroke
- Keywords
- Oropharyngeal Dysphagia, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- Medical Research Council, University of Nottingham
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 7 Sep 2017 (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 study is designed to explore the effectiveness of non-invasive cerebellar stimulation to enhance motor plasticity in the cortex after stroke. The investigators have shown that the human cerebellum is strongly activated during the act of swallowing and when stimulated with single TMS pulses can strongly facilitate the corticobulbar projection to the pharynx in humans. More recently the investigators have identified the most relevant frequency of stimulation of the cerebellum that can produce longer term excitation in the human swallowing motor system. The investigators therefore believe that the potential for cerebellar stimulation in improving swallowing is much greater than other methods for two reasons. Firstly, previous work has shown that unlike successful recovery of hand/arm function which relies on restoring activity in the stroke hemisphere, recovery of swallowing function relies on increased excitability in intact projections from the non-stroke hemisphere. The investigators believe that methods that can enhance these undamaged pathways have a greater chance of inducing recovery in the human swallowing system in unilateral stroke. Additionally cerebellar stimulation produces very high levels of corticobulbar excitation it may also have the advantage of improving dysphagia in posterior fossa strokes. Second, the human cerebellum is relatively easy to target and stimulate and has reduced risk of inducing unwanted effects (such as seizures) which as a consequence makes cerebellar stimulation a more pragmatic method for delivering therapeutic neurorehabilitation to dysphagic stroke patients compared to other more complex/riskier methods.
A final factor is that the investigators have developed a "virtual lesion" model of swallowing dysfunction in healthy volunteers which can be reversed quite successfully with other neuro-stimulation protocols. The investigators can therefore use this model to test the effectiveness of cerebellar stimulation protocols (ipsilateral and contralateral cerebellar sites) before choosing the most effective side to apply stimulation in a proof of principle trial/study in a small group of sub-acute dysphagic patients.
The hypotheses are that cerebellar TMS will:
- Reverse the brain inhibition and behavioural dysfunction following a virtual lesion model of disrupted swallowing in healthy brain (phase 1); ii. Reduce the degree of aspiration in acute dysphagia after a stroke (phase 2).
Detailed description
Protocols:
Hypothesis 1:
Cortical excitability (in both dominant and non-dominant swallowing cortex) to TMS and swallowing behaviour assessed with a swallowing reaction time task will be measured at baseline. Thereafter, the virtual lesion paradigm will be applied to the dominant swallowing projection followed by the cerebellar intervention (10Hz, 250 pulses). Cerebellar stimulation will be applied (in a randomised fashion) on separate occasions to both the contralateral and ipsilateral cerebellar hemispheres, immediately after the virtual lesion. The investigators have found that placement using known reference landmarks are equivalent to using neuronavigation, so the latter will not be employed. Repeat measurements of cortical excitability and swallowing behaviour will then be performed and analysed against baseline data and a sham cerebellar paradigm. Differences in cortical excitability and swallowing responses will thus be an indication of which cerebellar region (contralesional/ipsilesional) can influence excitability and reverse any behavioural changes most effectively.
Hypothesis 2:
- Dysphagic stroke patients (n=24) recruited over a 9 month period within 14 days of stroke ictus will have their swallowing assessed by videofluoroscopy before and after receiving either the real or sham cerebellar stimulation (10Hz, 250 pulses) as determined from phase 1. As before, placement of the coil for cerebellar stimulation will be performed using landmarks already established and validated in the work from question 1. Patients will be intubated with the pharyngeal EMG catheter for pre and post recordings of pharyngeal motor evoked potentials (MEPs) to cortical TMS. Power calculations, based on a similar study of pharyngeal stimulation indicated that the investigators would need 12 patients per group to achieve a statistical power of 80% at a 5% significance level to detect changes in the primary outcome measure of aspiration. In this study, the investigators will examine if the chosen site of cerebellar stimulation from phase 1 can induce short-term changes in brain function (pharyngeal MEPs) and swallowing function (videofluoroscopy) compared to sham interventions and baseline measurement, up to 1 hour after the intervention.
II. Following stage I, once it is established that cerebellar stimulation can alter brain and swallowing functions in stroke in the short-term, it will need to be appraised for clinical feasibility, dose response, and longer term efficacy. Dysphagic stroke patients (n=48, 16 patients per group) admitted to the stroke unit and identified by videofluoroscopy will be recruited over the next 21 months. Since it is not known how the cerebellar stimulation method should be delivered to patients, a dose ranging treatment trial will be utilised, randomising patients to one of three groups (A-C), low level stimulation, high level stimulation and sham stimulation. From our previous work with pharyngeal stimulation, the investigators propose that group A will receive stimulation once per day for 3 days. Group B will receive stimulation twice per day for 5 days. Group C will receive sham stimulation (delivered as in protocol I) twice a day for 5 days. Groups A and B will receive stimulation at the optimal site (10Hz, 250 pulses) found in question 1, but all groups will also receive standard speech and language therapy.
Assessments:
Swallowing before and after stimulation will be evaluated using videofluoroscopy, at 1 hour for protocol I. For protocol II the investigators propose both videofluoroscopy and functional scores (Functional oral ingestion scale (FOIS), the dysphagia severity rating scale (DSRS) including feeding status and modified rankin scale (mRS)) at baseline and at 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Hypothesis 2 Protocol 2 Low dose TMS | Active comparator | Device: Cerebellar TMSLow level cerebellar TMS. Delivered once per day for 3 days. |
| Hypothesis 2 Protocol 2 High dose TMS | Active comparator | Device: Cerebellar TMSHigh level cerebellar TMS. Delivered twice per day for 5 days. |
| Hypothesis 2 Protocol 2 Sham | Sham comparator | Device: Sham cerebellar TMSSham cerebellar TMS. Delivered twice a day for 5 days. |
| Hypothesis 2 Protocol 1 Cerebellar TMS | Active comparator | Device: Cerebellar TMSCerebellar TMS at 10Hz, 250 pulses. |
| Hypothesis 2 Protocol 1 Sham | Sham comparator | Device: Sham cerebellar TMSSham cerebellar TMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years and over
- All patients with an acute anterior or posterior cerebral circulation stroke within 6 weeks of symptom onset.
Key exclusion criteria (6 listed)
- Advanced dementia
- Previous history of dysphagia
- Patients judged to be clinically unstable
- Presence of implanted cardiac pacemaker or defibrillator
- Any severe chronic medical condition that compromises cardiac or respiratory status
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 |
|---|---|---|
| Cerebellar TMSCerebellar transcranial magnetic stimulation | Device | Hypothesis 2 Protocol 1 Cerebellar TMS, Hypothesis 2 Protocol 2 High dose TMS, Hypothesis 2 Protocol 2 Low dose TMS |
| Sham cerebellar TMSSham cerebellar transcranial magnetic stimulation | Device | Hypothesis 2 Protocol 1 Sham, Hypothesis 2 Protocol 2 Sham |
Primary outcome
Penetration aspiration scores on videofluoroscopy (number of swallows out of 6 that score 3 or more on the penetration aspiration scale) (Hypothesis 2 protocols 1 and 2)
Time frame: 1 hour post intervention and 2 weeks post intervention
Penetration aspiration scores on videofluoroscopy (number of swallows out of 6 that score 3 or more on the penetration aspiration scale)
1 secondary outcome
Improvement of: Functional oral ingestion scale (FOIS) and or the dysphagia severity rating scale (DSRS) (Hypothesis 2 protocol 2)
Time frame: 2 weeks post intervention
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 1 Dec 2022.
- Background: PubMed 8685928Smithard DG, O'Neill PA, Parks C, Morris J. Complications and outcome after acute stroke. Does dysphagia matter? Stroke. 1996 Jul;27(7):1200-4. doi: 10.1161/01.str.27.7.1200.
- Background: PubMed 23076886Geeganage C, Beavan J, Ellender S, Bath PM. Interventions for dysphagia and nutritional support in acute and subacute stroke. Cochrane Database Syst Rev. 2012 Oct 17;10:CD000323. doi: 10.1002/14651858.CD000323.pub2.
- Background: PubMed 8937283Finucane TE, Bynum JP. Use of tube feeding to prevent aspiration pneumonia. Lancet. 1996 Nov 23;348(9039):1421-4. doi: 10.1016/S0140-6736(96)03369-7. No abstract available.
- Background: PubMed 19445910Machado AG, Baker KB, Schuster D, Butler RS, Rezai A. Chronic electrical stimulation of the contralesional lateral cerebellar nucleus enhances recovery of motor function after cerebral ischemia in rats. Brain Res. 2009 Jul 14;1280:107-16. doi: 10.1016/j.brainres.2009.05.007. Epub 2009 May 12.
- Background: PubMed 26215752Park HJ, Furmaga H, Cooperrider J, Gale JT, Baker KB, Machado AG. Modulation of Cortical Motor Evoked Potential After Stroke During Electrical Stimulation of the Lateral Cerebellar Nucleus. Brain Stimul. 2015 Nov-Dec;8(6):1043-8. doi: 10.1016/j.brs.2015.06.020. Epub 2015 Jul 8.
- Background: PubMed 10200226Hamdy S, Rothwell JC, Brooks DJ, Bailey D, Aziz Q, Thompson DG. Identification of the cerebral loci processing human swallowing with H2(15)O PET activation. J Neurophysiol. 1999 Apr;81(4):1917-26. doi: 10.1152/jn.1999.81.4.1917.
- Background: PubMed 21838728Jayasekeran V, Rothwell J, Hamdy S. Non-invasive magnetic stimulation of the human cerebellum facilitates cortico-bulbar projections in the swallowing motor system. Neurogastroenterol Motil. 2011 Sep;23(9):831-e341. doi: 10.1111/j.1365-2982.2011.01747.x.
- Background: PubMed 26316351Vasant DH, Michou E, Mistry S, Rothwell JC, Hamdy S. High-frequency focal repetitive cerebellar stimulation induces prolonged increases in human pharyngeal motor cortex excitability. J Physiol. 2015 Nov 15;593(22):4963-77. doi: 10.1113/JP270817. Epub 2015 Sep 30.
- Background: PubMed 17932140Mistry S, Verin E, Singh S, Jefferson S, Rothwell JC, Thompson DG, Hamdy S. Unilateral suppression of pharyngeal motor cortex to repetitive transcranial magnetic stimulation reveals functional asymmetry in the hemispheric projections to human swallowing. J Physiol. 2007 Dec 1;585(Pt 2):525-38. doi: 10.1113/jphysiol.2007.144592. Epub 2007 Oct 11.
- Background: PubMed 9683316Hamdy S, Rothwell JC. Gut feelings about recovery after stroke: the organization and reorganization of human swallowing motor cortex. Trends Neurosci. 1998 Jul;21(7):278-82. doi: 10.1016/s0166-2236(97)01212-5.
- Background: PubMed 8898748Hamdy S, Aziz Q, Rothwell JC, Singh KD, Barlow J, Hughes DG, Tallis RC, Thompson DG. The cortical topography of human swallowing musculature in health and disease. Nat Med. 1996 Nov;2(11):1217-24. doi: 10.1038/nm1196-1217.
- Background: PubMed 10409170Hamdy S, Mikulis DJ, Crawley A, Xue S, Lau H, Henry S, Diamant NE. Cortical activation during human volitional swallowing: an event-related fMRI study. Am J Physiol. 1999 Jul;277(1):G219-25. doi: 10.1152/ajpgi.1999.277.1.G219.
- Individual participant dataSharing planned: No. No identifiable individual participant information will be shared outside the immediate research team. However, identifiable individual participant information will be made available to the Medical research council and the University of Manchester if required for the purposes of auditing the study.
Related trials for Oropharyngeal Dysphagia
RecruitingObservational study
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Brief Resolved Unexplained Event, Apparent Life Threatening Event
RecruitingPhase 2
Wearable Biofeedback for Swallowing Disorders Rehabilitation in Stroke and Parkinson Disease
Dysphagia, Stroke
Recruiting
K01 Impacts of Lingual Endurance Exercise
Dysphagia, Dysphagia, Oropharyngeal
RecruitingPhase 2
Adaptive RadioTherapy for OroPharynx Cancer
Oropharynx Cancer, Radiotherapy; Complications
Recruiting
Tongue-strengthening Exercises in People With ALS.
ALS (Amyotrophic Lateral Sclerosis), ALS - Amyotrophic Lateral Sclerosis
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.
Shaheen Hamdy, MBChB, PhD principal investigator
University of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebellar TMS in people with Oropharyngeal Dysphagia and Stroke, run by University of Manchester at 2 sites 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 2 inclusion and 6 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 1 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Penetration aspiration scores on videofluoroscopy (number of swallows out of 6 that score 3 or more on the penetration aspiration scale) (Hypothesis 2 protocols 1 and 2) (time frame: 1 hour post intervention and 2 weeks post 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 NCT03274947, which also lists 22 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 1 Dec 2022.