TABLE 2.
Interventional studies for nuclear medicine applications in ischemic and haemorrhagic stroke treatment.
| NCT Number | Study Title | Conditions | Interventions | Primary and Secondary Outcome Measures | Enrolment | Study Design | Location |
| Haiting et al. (32) | Dengzhanxixin injection ameliorates cognitive impairment through a neuroprotective mechanism based on mitochondrial preservation in patients with acute ischemic stroke | Acute ischemic stroke with mild to moderate cognitive impairment | Dengzhanxixin injection versus placebo or standard care changes in brain mitochondrial function evaluated by PET scans | • Reduction in infarct volume measured by MRI, improvement in cognitive function assessed by standardized cognitive tests, survival rate of neuronal cells in the ischemic penumbra • Reduction in neurological deficits assessed by clinical scales NIH score, adverse effects related to dengzhanxixin injection administration |
83 Adults | Randomized, parallel, double masking | China |
| Zhang et al. (33) WWH021 | Effect of combined use of Buyang Huanwu decoction and olanzapine on clinical symptoms, neurological function, and degree of dementia in patients with vascular dementia after cerebral ischemic stroke | Vascular dementia post cerebral ischemic stroke | Buyang Huanwu decoction and olanzapine versus conventional group treated with olanzapine evaluated by PET scans | • Improvement in clinical symptoms measured by Mini-Mental State Examination and the Montreal Cognitive Assessment • Cerebral blood flow measured using single photon emission computed tomography (SPECT) and MRI perfusion to evaluate the effects of the treatment on cerebral perfusion, brain imaging changes assessed using MRI and CT scans to observe changes in brain structure and the extent of ischemic damage or brain atrophy |
98 Adults | Randomized, parallel, double masking | China |
| Chen et al. (34) | The NeuroAiD II (MLC901) in vascular cognitive impairment study (NEURITES) | Vascular cognitive impairment post-stroke | NeuroAiD II (MLC901) versus placebo evaluated by PET and SPECT scans | • Improvement in clinical symptoms measured by Mini-Mental State Examination and the Montreal Cognitive Assessment • Using PET and SPECT scans to measure changes in cerebral perfusion and metabolic activity in the brain, and the use of MRI and CT scans to observe changes in brain structure, particularly in areas affected by vascular cognitive impairment |
100 Adults | Phase II, randomized, parallel, double masking | China |
| NCT 04759950 (35) | Exercise the mind and brain. A multimodal intervention | Chronic stroke post-recovery | Behavioural multicomponent physical activity versus mindfulness stress reduction versus behavioural computerized cognitive train fMRI | • Clarify the neuroplasticity change (within 3 months after treatment at baseline) • The assessment includes medical, integrating cognitive, social, psychological evaluations, neuroimaging, and biological samples collection, stroke specific quality of life, time physical and activity questionnaire |
141 adults including older adults | Randomized, parallel, double masking | Spain |
| Sui et al. (36) | Effects of trunk training using motor imagery on trunk control ability and balance function in patients with stroke | Post-stroke patients with motor dysfunction | Trunk training using motor imagery fMRI versus rehabilitation therapy | • fMRI to observe changes in brain activation patterns related to motor imagery tasks, indicating neural plasticity and adaptation in motor areas of the brain. • Diffusion tensor imaging (DTI): To evaluate changes in white matter integrity, potentially reflecting improvements in neural connectivity and structural reorganization in response to rehabilitation interventions. |
100 Adults | Randomized, parallel, double masking | China |
| Ahmaed et al. (37) | Endovascular coiling versus surgical clipping in the treatment of ruptured anterior communicating artery aneurysm in Cairo university hospitals | Ruptured anterior communicating artery aneurysm with Hunt and Hess grade I, II or III | Endovascular coiling versus surgical clipping in spontaneous subarachnoid hemorrhage | • The effectiveness of aneurysm occlusion post-procedure, as assessed by follow-up imaging studies such as digital subtraction angiography and MRI • Using CT and MRI perfusion, and transcranial Doppler ultrasonography to assess changes in cerebral blood flow and perfusion parameters post-treatment |
30 Adults | Prospective, randomized, parallel, double masking | Egypt |
| NCT 02791997 (38) | Audition after a lesion in migraine (audition postlesion) | Auditory process after brain (temporal or frontal) migraine | Neuropsychological tests versus neurophysiological markers (MRI, electro-, magnetoencephalography) | • To characterize auditory deficits after brain damage, investigate attention, short-term memory, sound-induced emotions • Percentages of correct responses, reaction times, and event-related potentials in neuropsychological tests up to two months |
262 adults including older adults | Randomized, parallel masking | France |
| ISRCTN 80619088 (39) | MR CLEAN-NO IV treatment followed by IA treatment versus direct IA treatment for acute ischaemic stroke caused by a proximal intracranial occlusion | Acute ischaemic stroke with intracranial large vessel occlusion of anterior circulation | Intra-arterial treatment, or intra-venous thrombolysis with alteplase followed by intra-arterial treatment assessed via CTA or magnetic resonance angiography (MRA) | • Functional outcome measured by modified Rankin scale (at 90 days) • Reperfusion measured by extended thrombolysis in cerebral infarction (eTICI) score of 2b or more on final angiography of intra-arterial treatment, recanalization rate assessed with CT angiography (at 24 hours), and final infarct volume measured on cranial non-contrast CT (at 5-7 days) after randomisation |
539 Adults | Randomized, parallel, double masking | Belgium, France, Netherlands |
| Walter et al. (40) NCT 00792220 | Mobile stroke-unit for reduction of the response time in ischemic stroke | Ischemic stroke | Mobile stroke unit car with integrated CT scan versus occm | • Investigate whether a rescue car equipped with integrated CT contributes to a better stroke management by saving precious time until a therapeutic decision is made • Time between emergency call and therapy decision (CT, blood analysis, start of thrombolysis, time between symptoms, and functional status) |
200 adults including older adults | Randomized, prospective, parallel masking | Germany |
| Koch et al. (41) NCT 01382862 | Phantom-s: the pre-hospital acute neurological therapy and optimization of medical care in stroke patients | Acute ischemic and haemorrhagic stroke | Stroke emergency mobile unit (alarm-to-needle time) with and without availability of specially staffed ambulance with CT scan and point-of care diagnosis | • Implement a specialized stroke emergency mobile unit will reduce alarm-to-needle (initiation of thrombolysis), alarm-to-imaging, alarm-to-point-of-care laboratory diagnostics a minimum of 20 min, in case of distal carotid occlusion, proximal MCA, space occupying cerebellar haemorrhage (at least 6 ml), intraventricular, and symptomatic ICH (36 hs after symptom onset up to 3 months), in-hospital mortality, functional outcomes, costs effectiveness • Telephone follow-up after 3 months |
614 adults including older adults | Phase II, prospective, randomized, parallel masking | Germany |
| Al-Shahi Salman et al. (42) | Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial | Intracranial haemorrhagic stroke (ICH) | Antiplatelet therapy on diffusion-weighted imaging (DWI) or diffusion tensor imaging (DTI) versus standard care | • The incidence of recurrent stroke or other vascular events. • Functional outcomes, mortality rates, and adverse events related to treatment. |
537 Adults | Randomized, parallel masking, open-label | United Kingdom |
| NCT 03038087 (43) | A study to test the sense device in patients with intracranial haemorrhage | Haemorrhagic stroke | Feasibility of sense device for bleed monitoring versus CT scan | • To assess a positive predictive value of the SENSE device for detecting number of patients correctly identified with haemorrhage expansion (> 3 ml increase in volume), serious device-related adverse events, or seizure (within 12-72 hs, up to 6 weeks) | 10 adults including older adults | Single masking, open-label | United States |
| NCT 03827720 (44) | Early feasibility study of the sense device | Ischemic and haemorrhagic stroke | Preliminary estimation of sense device safety in large vessels occlusion versus non | • Correlation of sense signal (within 24 hs of stroke symptom), change in received power measured and accuracy of sense algorithm, with diagnostic CT scan for stroke severity (location), haemorrhage volume, cerebral oedema, and acute ischemic stroke with large vessels occlusion monitors within 45 min | 20 adults including older adults | Randomized, parallel masking | United States |
| NCT 02258789 (45) | Assessment and training visio-spatial neglect in a virtual reality environment | Hemispatial neglect in chronic stroke (right-sided ischemia) | Virtual reality technology versus method | • Stimulating attention network: top-down scan training in a 3d game, combined with intense visual, audio, and tactile bottom-up stimulation, motor for home rehabilitation and tele-medicine approaches • Neglect assessment of clinical and behavioural score changes, star cancellation test, line bisection, baking tray, Posner task, extinction, catherine Bergego scale, within 1 week after intervention • Catherine bergego scale, change in score in spatial attention daily life activities, self-report from patient and relative within 6 month follow up |
15 adults including older adults | Single masking, open-label | Sweden |
| NCT 06341777 (46) | Multisensory telerehabilitation for visual field defects | Visual field defect follows stroke hemianopia, brain injuries | Behavioral: audio-visual training telerehabilitation | • Verifying the feasibility and efficacy of a novel telerehabilitation use a multisensory scan therapy • Measure its effects on visual functions, daily activities, looking for neural indicators of the therapy-induced improvements within 6 months follow up |
72 Children, adults including older adults | Randomized, parallel, single masking | Italy |
| NCT 05466487 (47) | Non-invasive brain stimulation as innovative treatment for chronic neglect patients | Spatial neglect in chronic stroke to promote function recovery | Transcranial alternat current stimulation behavioral visual scan train versus neglect train with sham stimulation | • To exploit principles of non-invasive brain stimulation to promote functional recovery in chronic stroke suffered from neglect symptoms • Combine evidence-based visual scan trained with transcranial alternating current stimulation treatment at alpha frequency • Computerized visual detection, star cancellation, quality of search score, baking tray, neuropsychological test, neglect questionnaire (at baseline and after 1, 9, 18 weeks, 3 months after termination of training session) |
22 adults including older adults | Randomized, double blind, parallel, quadruple masking | Netherland |
| NCT 03302741 (48) | 3d image innervation zone distribution in spastic muscles from high-density surface electromyography (EMG) | Muscle spasticity after stroke, amyotrophic lateral sclerosis | New 3d image guide botulinum neurotoxin versus physical therapy | • Spasticity assessed by reflex torque of elbow flexors, modified Ashworth scale, receive a total of 60 degrees (50-100 sec at 1 day baseline to 3 weeks) of computer-controlled elbow extension stretching at different speeds | 17 adults including older adults | Phase IV, randomized, parallel, masking | United States |
| Lee et al. (49) NCT 03048968 | The effect of a walking assist robot on gait function and brain activity in stroke patients and elderly adults | Stroke | New wearable hip assist robot technology on gait, sit-to-stand movement, stair climbing and treadmill gait versus sit-to-stand movement and treadmill gait versus gait enhancing mechatronic system versus treadmill | • To investigate the effects of new wearable hip assist robot, gait enhancing and motivating system Cortical activation measured by functional near-infrared-spectroscopy during treadmill gait (30 min), berg balance (sitting and standing balance during transfers), fall efficacy, and modified ranking scale to assess static balance and fall risk, 10 items questionnaire | 40 adults including older adults | Randomized, parallel masking | Korea |
| Lazaridou et al. (50) | Diffusion tensor and volumetric MRI using MR-compatible hand-induced robotic device suggests training-induced neuroplasticity in patients with chronic stroke | Chronic stroke | MR-compatible hand-induced robotic device evidenced by diffusion tensor imaging and volumetric MRI | • To investigate whether the use of an MR-compatible hand-induced robotic device in chronic stroke patients could lead to observable neuroplastic changes as evidenced by diffusion tensor imaging and volumetric MRI • To assess changes in white matter integrity and brain volume before and after the intervention • Any functional improvements in hand motor function or other relevant clinical outcomes after undergoing the robotic device training |
19 Adults | Randomized, parallel masking | United States |
| NCT 05844722 (51) | Effectiveness of mindfulness cognitive therapy undergoing post-stroke rehabilitation | Stroke rehab mindfulness | Behavioral mindfulness cognitive therapy versus usual care | • Efficacy of mindfulness changes on beck severity of depression and anxiety state-trait inventory (at baseline, 6 weeks, 3 months) • Global index of attention and perception is calculated using a five-facet mindfulness questionnaire with 39 items scored to assess sustained attention, sensorimotor impairment, functional independence of basic activity of daily living |
93 adults including older adults | Randomized, parallel masking | Hungary |
| Liu et al. (52) | Clinical study of opposing needling combined with eye acupuncture for treatment of muscle spasm post-stroke hemiplegia patients | Post-stroke hemiplegic patients | Acupuncture treatment, needling combined with eye acupuncture, versus basic rehabilitation treatment | • To assess the effectiveness of opposing needling combined with eye acupuncture therapy in reducing muscle spasms. • Improvements in functional mobility and activities of daily living, patient-reported measures of pain reduction, quality of life improvements, or satisfaction with the treatment regimen. |
69 Adults | Randomized, parallel masking | China |
| NCT 03648957 (53) | Lifestyle counselling as secondary prevention in patients with minor stroke or TIA | Acute minor ischemic stroke, TIA, haemorrhagic stroke | Lifestyle counselling targeting smoking, physical activity, adherence to preventive medication as secondary prevention versus usual care | • Evaluate the feasibility and effect of an early initiated counselling intervention changes on resting systolic blood pressure and adherence rate (from baseline and 3 months follow up) • Explored barriers and facilitators for health behavior after stroke, include perceived needs and social support |
40 adults including older adults | Randomized, parallel masking | Denmark |