Ultrasound Stimulation for Patients in a Disorder of Consciousness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorUniversity of California, Los Angeles
About this trial
The overall aim of this study is to develop an intervention that can help recovery in patients surviving severe brain injury but failing to fully recover. In particular, this multicenter project aims to (1) establish short-term efficacy of tFUS as a therapeutic to promote recovery in patients with prolonged DoC as compared to sham treatment, (2) establish dose-related safety and efficacy of tFUS as a therapeutic intervention in prolonged DoC patients and (3) explore preliminary predictors and biomarkers of susceptibility and response to thalamic sonication.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of DoC, following international guidelines, as assessed with the CRS-R.
Prolonged status (>28days post-injury)
If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and the patient will be willing to remain on a stable regimen during the protocol.
legally authorized representative available to consent for the patient to participate in the study
Disqualifiers
History of neurological disorder (other than the brain injury).
Metal implant or other condition precluding safe entry in the MR-environment.
Manifest continuous spontaneous movement (which would prevent safe/successful imaging).
Participation in another concurrent clinical trial.
Trial design
Design model
Parallel
Treatments tested in this trial
The Brainsonix BX Pulsar 1002 was designed to deliver low-intensity focused ultrasound pulsations (LIFUP) to the human brain.
DeviceThe BX Pulsar 1002 consists of two main elements: the transducer and the ultrasound console. The transducer itself and the housing for it went through several iterations in order to be compatible with an MRI environment. Currently, the transducer and its housing are deemed MR-conditional at 3T with SAR ≤ 2W/kg. The design includes a solid acoustic coupling gel pad attached to the front of the transducer to provide good acoustic transmission into the scalp. An outer housing was designed to attach the transducer firmly to the head above the temporal window, and to allow it to be moved side to side to accurately target intended structures.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Sham-tFUS groupSham comparator 1 intervention
Group B: tFUS-tFUS groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Establish short-term efficacy of tFUS as a therapeutic to promote recovery in patients with prolonged DoC as compared to sham treatment.
Outcome measures collected prior to tFUS/sham sessions will be compared to outcome measures obtained one week after tFUS/sham sessions. The two endpoint measures used will be one DoC-specific measure: the Coma Recovery Scale Revised (CRS-R). The Coma Recovery Scale Revised (CRS-R) ranges from 0 to 23 points, with higher scores indicating better neurological function and level of consciousness. A score of 0 represents the lowest level of neurological functioning, while a score of 23 represents the highest level of neurological functioning.
Time frame
From Day 1 to 162
Establish dose-related safety and efficacy of tFUS as a therapeutic intervention in prolonged DoC patients.
Safety. Proportion of (severe) adverse events (primary measure) will be documented using the Adverse Event Questionnaire (AEQ, also used in NCT04921683) and the Vital signs CRF (F0026),22 within one week of intervention/sham, in the tFUS-tFUS group and in the Sham-tFUS group
Time frame
From Day 1 to 163
Explore preliminary predictors and biomarkers of susceptibility and response to thalamic sonication.
using the EEG recordings, power spectral density will be calculated within predefined frequency band and ABCD level classification (that reflects the degree of thalamocortical disconnection; primary measure) will be applied based on spectral peaks in these frequencies. This measure is calculated in percentage (%) of total power density.
Time frame
From Day 1 to 16Secondary outcomes
1
Establish short-term efficacy of tFUS as a therapeutic to promote recovery in patients with prolonged DoC as compared to sham treatment
Outcome measures collected prior to tFUS/sham sessions will be compared to outcome measures obtained one week after tFUS/sham sessions. The two endpoint measures used will be one specific to TBI functional outcome: the Disability Rating Scale (DRS). The Disability Rating Scale (DRS) ranges from 0 to 30 points, with higher scores indicating more severe disability. A score of 0 represents no disability, while a score of 30 represents extreme vegetative state or death.
Time frame
From Day 1 to 162
Establish dose-related safety and efficacy of tFUS as a therapeutic intervention in prolonged DoC patients.
Efficacy. Changes will be assessed, one week after intervention/sham, in the tFUS-tFUS group as compared to the Sham-tFUS group using the CRS-R. The Coma Recovery Scale Revised (CRS-R) ranges from 0 to 23 points, with higher scores indicating better neurological function and level of consciousness. A score of 0 represents the lowest level of neurological functioning, while a score of 23 represents the highest level of neurological functioning.
Time frame
From Day 1 to 163
Explore preliminary predictors and biomarkers of susceptibility and response to thalamic sonication.
TBI specific efficacy will be tested based on the change observed one week after tFUS sessions as compared to sham sessions using the CRS-R (secondary measure) in both TBI and non-TBI groups
Time frame
From Day 1 to 16Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
Casa Colina Hospital and Centers for Healthcare
Collaborator
Spaulding Rehabilitation Hospital
Collaborator
Massachusetts General Hospital
Collaborator
Source ClinicalTrials.gov