StrokeNCT02645344
Effects of Repetitive Transcranial Magnetic Stimulation Combined With Sensory Cueing on Unilateral Neglect in Subacute Patients With Right Hemispheric Stroke
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS), Sensory Cueing (SC) and Conventional Rehabilitation in people with Stroke, run by The Hong Kong Polytechnic University.
Trial summary
The objective was to compare the effects of repetitive Transcranial Magnetic Stimulation (rTMS) combined with sensory cueing (SC), rTMS alone, and conventional rehabilitation on reducing unilateral neglect (UN) and improving hemiplegic arm functions and performance of activities of daily living (ADL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation (rTMS), Sensory Cueing (SC) and Conventional Rehabilitation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Aug 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of right-hemispheric stroke
- Duration since onset of more than one week
- Presenting with unilateral neglect, confirmed by the conventional subtests of the BIT with cutoff scores of 129
- First-ever stroke, or unilateral neglect as the consequence of the last stroke
- Being aged 18 or over
- Mini Mental State Examination score of ≥17
- Giving written consent to participate.
Who cannot join
- Duration since onset of stroke of more than six months
- Medically unstable
- Epileptic seizures, unconsciousness, or intracranial hypertension
- Serious heart disease
- Gravid
- Severe aphasia so as to have difficulty understanding the therapists' instructions
- Metal implants in vivo
About this study
Official title: Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) Combined With Sensory Cueing (SC) on Unilateral Neglect in Subacute Patients With Right Hemispheric Stroke: A Randomized Controlled Study
The objective was to compare the effects of repetitive Transcranial Magnetic Stimulation (rTMS) combined with sensory cueing (SC), rTMS alone, and conventional rehabilitation on reducing unilateral neglect (UN) and improving hemiplegic arm functions and performance of activities of daily living (ADL). Sixty subacute patients with left UN after right-hemispheric stroke were randomly assigned to three groups; rTMS combined with SC, rTMS alone, and conventional rehabilitation. rTMS at 1 Hz was applied over P5 of the contralesional hemisphere while vibration cueing was emitted using a wristwatch device on the hemiplegic arm, five days per week for two weeks. The first two groups received the same dosage of conventional rehabilitation on top of their experimental interventions. Blinded assessments were administered at baseline, 2 weeks postintervention, and four-week follow-up upon completion of training.
- Conditions
- Stroke
- Being tested
- Repetitive Transcranial Magnetic Stimulation (rTMS), Sensory Cueing (SC), Conventional Rehabilitation
- Keywords
- Unilateral neglect, Right hemiplegia
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic Stimulation (rTMS)Device
Sensory Cueing (SC)Behavioural
Conventional RehabilitationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Experimental | Low frequency rTMS at 1 Hz was applied over P5 of the contralesional hemisphere in addition to conventional rehabilitation Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Conventional Rehabilitation |
| rTMS combined with sensory cueing (SC) | Experimental | Vibration cueing was emitted using a wristwatch device on the hemiplegic arm combined with low frequency rTMS in addition to conventional rehabilitation Receives: Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Behavioral: Sensory Cueing (SC); Behavioral: Conventional Rehabilitation |
| Conventional rehabilitation | Active comparator | Physical therapy and occupational therapy Receives: Behavioral: Conventional Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavior Inattention Test (BIT)
Measured: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Catherine Bergego Scale (CBS)
Measured: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Secondary outcomes (3)
Fugl-Meyer Assessment (FMA)
Measured: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Action Research Arm Test (ARAT)
Measured: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Modified Barthel index (MBI)
Measured: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startJun 2013
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital
- Responsible party
- Principal investigator, Kenneth N. K. Fong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645344
- Sponsor's protocol ID
- HSEARS20130720002
- Status last verified
- Jan 2016
- First submitted
- 23 Dec 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fong KN, Lo PC, Yu YS, Cheuk CK, Tsang TH, Po AS, Chan CC. Effects of sensory cueing on voluntary arm use for patients with chronic stroke: a preliminary study. Arch Phys Med Rehabil. 2011 Jan;92(1):15-23. doi: 10.1016/j.apmr.2010.09.014.
PubMed 21187201Fong KN, Yang NY, Chan MK, Chan DY, Lau AF, Chan DY, Cheung JT, Cheung HK, Chung RC, Chan CC. Combined effects of sensory cueing and limb activation on unilateral neglect in subacute left hemiplegic stroke patients: a randomized controlled pilot study. Clin Rehabil. 2013 Jul;27(7):628-37. doi: 10.1177/0269215512471959. Epub 2013 Feb 12.
PubMed 23405025
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) Combined With Sensory Cueing (SC) on Unilateral Neglect in Subacute Patients With Right Hemispheric Stroke: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02645344
- Acronym / sponsor ID
- HSEARS20130720002
- Conditions
- Stroke
- Keywords
- Unilateral neglect, Right hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- West China Hospital
- Study start
- Jun 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 1 Jan 2016 (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.
The objective was to compare the effects of repetitive Transcranial Magnetic Stimulation (rTMS) combined with sensory cueing (SC), rTMS alone, and conventional rehabilitation on reducing unilateral neglect (UN) and improving hemiplegic arm functions and performance of activities of daily living (ADL). Sixty subacute patients with left UN after right-hemispheric stroke were randomly assigned to three groups; rTMS combined with SC, rTMS alone, and conventional rehabilitation. rTMS at 1 Hz was applied over P5 of the contralesional hemisphere while vibration cueing was emitted using a wristwatch device on the hemiplegic arm, five days per week for two weeks. The first two groups received the same dosage of conventional rehabilitation on top of their experimental interventions. Blinded assessments were administered at baseline, 2 weeks postintervention, and four-week follow-up upon completion of training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Conventional RehabilitationLow frequency rTMS at 1 Hz was applied over P5 of the contralesional hemisphere in addition to conventional rehabilitation |
| rTMS combined with sensory cueing (SC) | Experimental | Device: Repetitive Transcranial Magnetic Stimulation (rTMS), Behavioral: Sensory Cueing (SC), Behavioral: Conventional RehabilitationVibration cueing was emitted using a wristwatch device on the hemiplegic arm combined with low frequency rTMS in addition to conventional rehabilitation |
| Conventional rehabilitation | Active comparator | Behavioral: Conventional RehabilitationPhysical therapy and occupational therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of right-hemispheric stroke
- Duration since onset of more than one week
- Presenting with unilateral neglect, confirmed by the conventional subtests of the BIT with cutoff scores of 129
- First-ever stroke, or unilateral neglect as the consequence of the last stroke
- Being aged 18 or over
Key exclusion criteria (7 listed)
- Duration since onset of stroke of more than six months
- Medically unstable
- Epileptic seizures, unconsciousness, or intracranial hypertension
- Serious heart disease
- Gravid
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 |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Device | Repetitive Transcranial Magnetic Stimulation (rTMS), rTMS combined with sensory cueing (SC) |
| Sensory Cueing (SC) | Behavioural | rTMS combined with sensory cueing (SC) |
| Conventional Rehabilitation | Behavioural | Conventional rehabilitation, Repetitive Transcranial Magnetic Stimulation (rTMS), rTMS combined with sensory cueing (SC) |
Primary outcome
Behavior Inattention Test (BIT)
Time frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Catherine Bergego Scale (CBS)
Time frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
3 secondary outcomes
Fugl-Meyer Assessment (FMA)
Time frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Action Research Arm Test (ARAT)
Time frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
Modified Barthel index (MBI)
Time frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
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 5 Jan 2016.
- Background: PubMed 21187201Fong KN, Lo PC, Yu YS, Cheuk CK, Tsang TH, Po AS, Chan CC. Effects of sensory cueing on voluntary arm use for patients with chronic stroke: a preliminary study. Arch Phys Med Rehabil. 2011 Jan;92(1):15-23. doi: 10.1016/j.apmr.2010.09.014.
- Background: PubMed 23405025Fong KN, Yang NY, Chan MK, Chan DY, Lau AF, Chan DY, Cheung JT, Cheung HK, Chung RC, Chan CC. Combined effects of sensory cueing and limb activation on unilateral neglect in subacute left hemiplegic stroke patients: a randomized controlled pilot study. Clin Rehabil. 2013 Jul;27(7):628-37. doi: 10.1177/0269215512471959. Epub 2013 Feb 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation (rTMS), Sensory Cueing (SC) and Conventional Rehabilitation in people with Stroke, run by The Hong Kong Polytechnic University.
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 7 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 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Behavior Inattention Test (BIT) (time frame: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)). The study lists 2 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 NCT02645344, which also lists 2 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 5 Jan 2016.