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Active, not recruiting Not applicable Interventional

Intervention to Change Affect Recognition and Empathy

NCT05636020
Conditions
Traumatic Brain Injury, Concussion, Intermediate, Concussion, Severe, Concussion With LOC 31 to 59 Minutes, Concussion With Brief Loss of Consciousness, Traumatic Brain Injury With Brief Loss of Consciousness, Traumatic Brain Injury With Loss of Consciousness, Traumatic Brain Injury With Prolonged Loss of Consciousness, Traumatic Brain Injury (TBI); Concussion, Initial Encounter, Traumatic Brain Injury (TBI); Concussion, Subsequent Encounter, Traumatic Brain Injury With No Loss of Consciousness, Traumatic Brain Injury With Open Intracranial Wound, Traumatic Brain Injury With Moderate Loss of Consciousness
Interventions
ICARE Treatment
Behavioral
Lead sponsor
Indiana University
Other
Eligibility
18 Years and older
Enrollment
85 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
1
States / cities
Indianapolis, Indiana
Conditions
Consciousness Disorders, Disorders of Consciousness Due to Severe Brain Injury
Interventions
The Brainsonix BX Pulsar 1002 was designed to deliver low-intensity focused ultrasound pulsations (LIFUP) to the human brain.
Device
Lead sponsor
University of California, Los Angeles
Other
Eligibility
18 Years to 79 Years
Enrollment
60 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
4
States / cities
Los Angeles, California • Pomona, California • Boston, Massachusetts + 1 more
Conditions
Consciousness Disorders, Disorders of Consciousness Due to Severe Brain Injury
Interventions
Low-intensity focused ultrasound
Device
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years to 79 Years
Enrollment
36 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
2
States / cities
Boston, Massachusetts • Cambridge, Massachusetts
Conditions
Disorder of Consciousness, Vegetative State, Minimally Conscious State, Minimally Conscious State Plus, Minimally Conscious State Minus, Traumatic Brain Injury, CVA (Cerebrovascular Accident), Anoxia, Brain, Thalamic Infarction, Coma; Prolonged
Interventions
BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation
Device
Lead sponsor
Casa Colina Hospital and Centers for Healthcare
Other
Eligibility
18 Years and older
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
1
States / cities
Pomona, California