NCT02336321 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cempini M, De Rossi SM, Lenzi T, Cortese M, Giovacchini F, Vitiello N, Carrozza MC
Kinematics and design of a portable and wearable exoskeleton for hand rehabilitation. IEEE Int Conf Rehabil Robot. 2013 Jun;2013:6650414. doi: 10.1109/ICORR.2013.6650414.
Cempini M, Marzegan A, Rabuffetti M, Cortese M, Vitiello N, Ferrarin M
Analysis of relative displacement between the HX wearable robotic exoskeleton and the user's hand. J Neuroeng Rehabil. 2014 Oct 18;11:147. doi: 10.1186/1743-0003-11-147.
Soekadar SR, Witkowski M, Vitiello N, Birbaumer N
An EEG/EOG-based hybrid brain-neural computer interaction (BNCI) system to control an exoskeleton for the paralyzed hand. Biomed Tech (Berl). 2015 Jun;60(3):199-205. doi: 10.1515/bmt-2014-0126.
Witkowski M, Cortese M, Cempini M, Mellinger J, Vitiello N, Soekadar SR
Enhancing brain-machine interface (BMI) control of a hand exoskeleton using electrooculography (EOG). J Neuroeng Rehabil. 2014 Dec 16;11:165. doi: 10.1186/1743-0003-11-165.

Restoration of Daily-life Hand Function Using a Brain/Neural-Computer Interaction (BNCI) System in Paralysis After Cervical Spinal Cord Injury

Clinical trial NCT02336321 - References