Spontaneous Intracerebral HemorrhagePREMANENCT07908264
PREcision MApping and NEuromodulation After Spontaneous Intracerebral Hemorrhage: The PREMANE Trial
A study testing Transcranial Magnetic Stimulation in people with Spontaneous Intracerebral Hemorrhage, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Spontaneous Intracerebral Hemorrhage
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Aug 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21 to 65 years old.
- A radiologically confirmed diagnosis of SICH on baseline CT-imaging
- Able to communicate in English (including patients with dysphasia and those who are unable to write)
Who cannot join
- Patients with hemorrhage related to trauma, tumor, ischemic stroke, vascular malformations, and other structural causes
- Prior cognitive impairments
- Pregnant women
- Foreigners
- FMA-UE score > 46
- MoCA score > 25
- Patients with history of seizures or an epileptic
- Patients who have been diagnosed with or have a history of mental health conditions (any psychological disorders)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Recruiting
Alexandra Hospital
Singapore
Nicodemus Oey, +65 6908 2222 ext. +65, Nicodemus_Edrick_Oey@nuhs.edu.sg
- Recruiting
National University Hospital
Singapore
Mervyn JR Lim, +65 6908 2222 ext. +65, mervynlim@u.nus.edu
Mervyn JR Lim
About this study
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.
Read more
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.
Read the detailed description
The investigators designed a randomised cross-over pilot trial of sham nTMS first or active nTMS first three-months after ICH followed by crossover after a three-week washout period. The patient, investigator, technician, and outcome assessor will be blinded to the patient's allocation in the trial. Each nTMS protocol lasts for one week (15 sessions per week for a total 30 sessions). nTMS consist of either the sham arm or active arm. Individual-specific nTMS targets will be localised using our pipeline for estimating high-quality individual-specific networks using fMRI. Standard care rehabilitation will be provided to all participants of the trial during the study period. Primary outcomes pre- and post-stimulation are measured using the Fugl-Meyer Upper Extremity Scale (FMA), Western Aphasia Battery (WAB), a detailed neuropsychological assessment that assess 6 cognitive sub-domains (cognition), Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT) and Paired associates learning (PAL). Functional outcomes will be assessed at baseline, 3-months, before and after each nTMS protocol, 6-months, and 1-year follow up. Secondary outcomes are changes in functional connectivity of brain networks using precision functional mapping techniques before and after each nTMS protocol.
- Conditions
- Spontaneous Intracerebral Hemorrhage
- Being tested
- Transcranial Magnetic Stimulation
- Keywords
- spontaneous intracerebral hemorrhage, transcranial magnetic stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham nTMS First | Sham comparator | Participants will be randomized into two groups to determine the sequence of intervention (active neuromodulation or sham stimulation first). Randomization will be performed using a computer-generated allocation sequence by an independent party not involved in outcome assessment. Sham stimulation will be provided by a sham coil. Active neuromodulation will be provided by an active coil.
The active neuromodulation protocol utilizes intermittent theta burst stimulation (iTBS). The stimulation parameters include:
* Intensity of 90% of resting motor threshold (RMT)
* 3 sessions per day over 5 consecutive days
* 1800 pulses per session Receives: Device: Transcranial Magnetic Stimulation |
| Active nTMS First | Experimental | Participants will be randomized into two groups to determine the sequence of intervention (active neuromodulation or sham stimulation first). Sham stimulation will be provided by a sham coil. Active neuromodulation will be provided by an active coil.
The active neuromodulation protocol utilizes intermittent theta burst stimulation (iTBS). The stimulation parameters include:
* Intensity of 90% of resting motor threshold (RMT)
* 3 sessions per day over 5 consecutive days
* 1800 pulses per session Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment: Upper Extremity
Measured: Immediately after the intervention
Montreal cognitive assessment score (MoCA)
Measured: Immediately after the intervention
Western Aphasia Battery
Measured: Immediately after the intervention
Secondary outcomes (4)
Paired Associates Learning
Measured: Immediately after the intervention
Trail Making Test
Measured: Immediately after the intervention
Changes in functional connectivity
Measured: Immediately after the intervention
All functional outcomes
Measured: 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Aug 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spontaneous Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Crossover
- Model description
- The investigators designed a randomised cross-over pilot trial of sham nTMS first or cognition nTMS first three-months after ICH followed by crossover after a three-week washout period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ng Teng Fong General Hospital, National University of Singapore, Alexandra Hospital
- Responsible party
- Sponsor
- Investigators
- Mervyn JR Lim, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908264
- Sponsor's protocol ID
- 2024-3505
- Other IDs
- CSSDFD24oct-001
- Acronym
- PREMANE
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD may be shared upon reasonable request, data security policy, and research collaboration agreements are in place.
Publications
Hofmeijer J, Ham F, Kwakkel G. Evidence of rTMS for Motor or Cognitive Stroke Recovery: Hype or Hope? Stroke. 2023 Oct;54(10):2500-2511. doi: 10.1161/STROKEAHA.123.043159. Epub 2023 Sep 25.
PubMed 37747964Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
PubMed 19833552Kim WS, Paik NJ. Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Brain Neurorehabil. 2021 Mar 18;14(1):e6. doi: 10.12786/bn.2021.14.e6. eCollection 2021 Mar.
PubMed 36742107Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.
PubMed 33243615
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREcision MApping and NEuromodulation After Spontaneous Intracerebral Hemorrhage: The PREMANE Trial
- ClinicalTrials.gov ID
- NCT07908264
- Acronym / sponsor ID
- PREMANE / 2024-3505
- Conditions
- Spontaneous Intracerebral Hemorrhage
- Keywords
- spontaneous intracerebral hemorrhage, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Ng Teng Fong General Hospital, National University of Singapore, Alexandra Hospital
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Nov 2026 (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.
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.
Detailed description
The investigators designed a randomised cross-over pilot trial of sham nTMS first or active nTMS first three-months after ICH followed by crossover after a three-week washout period. The patient, investigator, technician, and outcome assessor will be blinded to the patient's allocation in the trial. Each nTMS protocol lasts for one week (15 sessions per week for a total 30 sessions). nTMS consist of either the sham arm or active arm. Individual-specific nTMS targets will be localised using our pipeline for estimating high-quality individual-specific networks using fMRI. Standard care rehabilitation will be provided to all participants of the trial during the study period. Primary outcomes pre- and post-stimulation are measured using the Fugl-Meyer Upper Extremity Scale (FMA), Western Aphasia Battery (WAB), a detailed neuropsychological assessment that assess 6 cognitive sub-domains (cognition), Montreal Cognitive Assessment (MoCA), Trail Making Test (TMT) and Paired associates learning (PAL). Functional outcomes will be assessed at baseline, 3-months, before and after each nTMS protocol, 6-months, and 1-year follow up. Secondary outcomes are changes in functional connectivity of brain networks using precision functional mapping techniques before and after each nTMS protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators designed a randomised cross-over pilot trial of sham nTMS first or cognition nTMS first three-months after ICH followed by crossover after a three-week washout period.
| Arm | Type | Receives |
|---|---|---|
| Sham nTMS First | Sham comparator | Device: Transcranial Magnetic StimulationParticipants will be randomized into two groups to determine the sequence of intervention (active neuromodulation or sham stimulation first). Randomization will be performed using a computer-generated allocation sequence by an independent party not involved in outcome assessment. Sham stimulation will be provided by a sham coil. Active neuromodulation will be provided by an active coil. The active neuromodulation protocol utilizes intermittent theta burst stimulation (iTBS). The stimulation parameters include: * Intensity of 90% of resting motor threshold (RMT) * 3 sessions per day over 5 consecutive days * 1800 pulses per session |
| Active nTMS First | Experimental | Device: Transcranial Magnetic StimulationParticipants will be randomized into two groups to determine the sequence of intervention (active neuromodulation or sham stimulation first). Sham stimulation will be provided by a sham coil. Active neuromodulation will be provided by an active coil. The active neuromodulation protocol utilizes intermittent theta burst stimulation (iTBS). The stimulation parameters include: * Intensity of 90% of resting motor threshold (RMT) * 3 sessions per day over 5 consecutive days * 1800 pulses per session |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 21 to 65 years old.
- A radiologically confirmed diagnosis of SICH on baseline CT-imaging
- Able to communicate in English (including patients with dysphasia and those who are unable to write)
Key exclusion criteria (8 listed)
- Patients with hemorrhage related to trauma, tumor, ischemic stroke, vascular malformations, and other structural causes
- Prior cognitive impairments
- Pregnant women
- Foreigners
- FMA-UE score > 46
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 StimulationThe 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. | Device | Active nTMS First, Sham nTMS First |
Primary outcome
Fugl-Meyer Assessment: Upper Extremity
Time frame: Immediately after the intervention
Montreal cognitive assessment score (MoCA)
Time frame: Immediately after the intervention
Western Aphasia Battery
Time frame: Immediately after the intervention
4 secondary outcomes
Paired Associates Learning
Time frame: Immediately after the intervention
Trail Making Test
Time frame: Immediately after the intervention
Changes in functional connectivity
Time frame: Immediately after the intervention
All functional outcomes
Time frame: 6 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 37747964Hofmeijer J, Ham F, Kwakkel G. Evidence of rTMS for Motor or Cognitive Stroke Recovery: Hype or Hope? Stroke. 2023 Oct;54(10):2500-2511. doi: 10.1161/STROKEAHA.123.043159. Epub 2023 Sep 25.
- Background: PubMed 19833552Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.
- Background: PubMed 36742107Kim WS, Paik NJ. Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Brain Neurorehabil. 2021 Mar 18;14(1):e6. doi: 10.12786/bn.2021.14.e6. eCollection 2021 Mar.
- Background: PubMed 33243615Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmoller J, Carpenter LL, Cincotta M, Chen R, Daskalakis JD, Di Lazzaro V, Fox MD, George MS, Gilbert D, Kimiskidis VK, Koch G, Ilmoniemi RJ, Lefaucheur JP, Leocani L, Lisanby SH, Miniussi C, Padberg F, Pascual-Leone A, Paulus W, Peterchev AV, Quartarone A, Rotenberg A, Rothwell J, Rossini PM, Santarnecchi E, Shafi MM, Siebner HR, Ugawa Y, Wassermann EM, Zangen A, Ziemann U, Hallett M; basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.
- Individual participant dataSharing planned: Undecided. IPD may be shared upon reasonable request, data security policy, and research collaboration agreements are in place.
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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.
Mervyn JR Lim principal investigator
National University Hospital, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Spontaneous Intracerebral Hemorrhage, run by National University Hospital, Singapore at 2 sites in Singapore.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mervyn JR Lim (+65 6908 2222 ext. +65, mervynlim@u.nus.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment: Upper Extremity (time frame: Immediately after the intervention). The study lists 3 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 NCT07908264, which also lists 4 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 2 Nov 2026; AzTrials last refreshed its copy on 7 Nov 2026.