Effects of Repetitive Transcranial Magnetic Stimulation Combined With Sensory Cueing on Unilatera… (NCT02645344) | Clinical Trial Compass
CompletedNot Applicable
Effects of Repetitive Transcranial Magnetic Stimulation Combined With Sensory Cueing on Unilateral Neglect in Subacute Patients With Right Hemispheric Stroke
60 participantsStarted 2013-06
Plain-language 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). 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined repetitive transcranial magnetic stimulation with sensory cueing specifically for unilateral neglect after right-hemisphere stroke — how do I know if the type of neglect I'm experiencing matches what was studied here, and whether those results would apply to my situation?
2Since this trial has already been completed and measured outcomes using tools like the Behavior Inattention Test and the Catherine Bergego Scale, has my care team assessed me with either of those tests, and what do my scores suggest about the severity of my neglect?
3This study was done in the subacute phase after stroke — does the timing of my recovery put me in a similar window, or have I moved past the point where this kind of treatment approach tends to show the most benefit?
4Repetitive TMS involves magnetic stimulation to the brain — given my specific medical history and any metal implants or seizure history I might have, what safety concerns should we talk through before considering this type of therapy?
5Now that this trial is completed, are its findings available, and based on what your team knows about the results, would you recommend this combined TMS and sensory cueing approach over other standard rehabilitation options for my neglect right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Behavior Inattention Test (BIT)
Timeframe: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)
2
Catherine Bergego Scale (CBS)
Timeframe: Change from baseline in 4 weeks (baseline, 2-week and 2-week after training)