drugset

drugset / Trial / NCT03814356

Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness

NCT03814356 ↗

Phase 1 Active not recruiting 10 enrolled Massachusetts General Hospital Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab

NaSingle-groupOpen-labelTreatment

Summary

Phase 1 of the STIMPACT trial is an open label,dose-escalation,safety study of intravenous (IV) methylphenidate (MPH) therapy in patients with disorders of consciousness (DoC) caused by severe brain injuries.

Timeline

Start: 2020-08-24
Primary completion: 2024-04-01
Completion: 2026-06-30

Publications

Background Edlow BL, Barra ME, Zhou DW, Foulkes AS, Snider SB, Threlkeld ZD, Chakravarty S, Kirsch JE, Chan ST, Meisler SL, Bleck TP, Fins JJ, Giacino JT, Hochberg LR, Solt K, Brown EN, Bodien YG. Personalized Connectome Mapping to Guide Targeted Therapy and Promote Recovery of Consciousness in the Intensive Care Unit. Neurocrit Care. 2020 Oct;33(2):364-375. doi: 10.1007/s12028-020-01062-7. Epub 2020 Aug 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylphenidate	Small molecule	0.5 mg/kg	Intravenous
Subject	Methylphenidate	Small molecule	1 mg/kg	Intravenous
Subject	Methylphenidate	Small molecule	2 mg/kg	Intravenous

Indications