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PREcision MApping and NEuromodulation After Spontaneous Intracerebral Hemorrhage: The PREMANE Trial
Sponsor: National University Hospital, Singapore
Summary
Spontaneous intracerebral haemorrhage (ICH) is a devastating form of stroke accounting for approximately 10-15% of all strokes globally. There is increasing evidence of younger working-age adults suffering from small-to-moderate sized spontaneous ICH, who develop significant motor and cognitive impairment after the event. These impairments contribute substantially to post-stroke functional morbidity and poor recovery, increasing care needs and decreasing economic productivity. Existing neuromodulation trials in stroke rehabilitation have applied transcranial magnetic stimulation (TMS) at fixed anatomical targets using group-level brain maps, which overlooks the substantial inter-individual variability in the spatial topography of functional brain networks after ICH. Precision functional mapping techniques have demonstrated that individual-specific brain networks can be estimated using densely sampled resting-state functional MRI (rs-fMRI) data and multi-session hierarchical Bayesian models (MS-HBM). These individual-specific networks can identify personalised neuromodulation targets for navigated TMS (nTMS) to improve rehabilitation outcomes. Intermittent Theta Burst Stimulation (iTBS) to the primary motor cortex (M1) has been shown to alter functional connectivity in a dose-dependent manner, while iTBS to the dorsolateral prefrontal cortex (DLPFC) improves attention and memory after left-hemispheric stroke. Precision neuromodulation using nTMS targeting individual-specific functional M1 and DLPFC areas for personalised stroke rehabilitation has yet to be sufficiently tested in high-quality clinical trials. The PREMANE trial aims to use precision functional mapping in individual patients with spontaneous intracerebral hemorrhage to investigate inter-individual connectivity changes over time and after navigated neuromodulation to deliver personalised neurorehabilitation for patients with ICH.
Key Details
Gender
All
Age Range
21 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-08-01
Completion Date
2028-12-31
Last Updated
2026-11-02
Healthy Volunteers
No
Conditions
Interventions
Transcranial Magnetic Stimulation
The trial intervention in this study is navigated transcranial magnetic stimulation (nTMS), a non-invasive neuromodulation technique used to modulate cortical activity. nTMS delivers focused magnetic pulses to targeted cortical regions, inducing electrical currents that can alter neuronal excitability and functional connectivity. In this study, stimulation targets will be individualized based on precision functional mapping derived from magnetic resonance imaging (MRI). The intervention will be delivered using an established intermittent theta burst stimulation (iTBS) protocol. Stimulation parameters will include an intensity of 90% of resting motor threshold (RMT), with multiple sessions administered per day over a defined treatment period. nTMS has a well-established safety profile when delivered within recommended guidelines. Common side effects include mild headache or scalp discomfort, while serious adverse events such as seizures are rare.
Locations (2)
Alexandra Hospital
Singapore, Singapore
National University Hospital
Singapore, Singapore