BridgeMD
New treatment option for Consciousness Disorders
Official title Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness
ClinicalTrials.gov ID: NCT06930716
What this study is testing
- What it's testing
- Prolonged disorders of consciousness (pDOC) are defined as DOC lasting \>1 year post injury for patients with Traumatic Brain Injury (TBI) and \>3 months post injury for patients with non-TBI and at present there are limited treatments that reliably lead to enhanced prognosis. The rehabilitation process throughout the continuum of care for patients with pDOC necessitates restorative strategies to facilitate arousal and functional recovery and coordinated medical management.
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Patients with a diagnosis of pDOC (includes coma, VS/UWS, MCS, MCS +, MCS-) as defined as disorder of consciousness (DOC) greater than 6 weeks post...
- Patients deemed medically safe to participate in physical therapy (PT) as evaluated by the study physicians.
You likely can't join if
- Patients who have emerged from MCS (CRS-R score 6 on Motor Function scale and/or 2 on Communication Scale).
- Patients medically unsafe for participation in PT as indicated by one of the study physicians (including but not limited to those receiving...
- Patients with DOC less than 6 weeks post onset will also be excluded.
- Patients who do not meet technical requirements of the RTTM device will be excluded
- weighing greater than 135 kg
- length of legs below 75 cm or above 100 cm,
See the full eligibility criteria
- Patients with a diagnosis of pDOC (includes coma, VS/UWS, MCS, MCS +, MCS-) as defined as disorder of consciousness (DOC) greater than 6 weeks post onset
- Patients deemed medically safe to participate in physical therapy (PT) as evaluated by the study physicians.
- Patients who have emerged from MCS (CRS-R score 6 on Motor Function scale and/or 2 on Communication Scale).
- Patients medically unsafe for participation in PT as indicated by one of the study physicians (including but not limited to those receiving intravenous sedation, those with integumentary breakdown or known pressure...
- Patients with DOC less than 6 weeks post onset will also be excluded.
- Patients who do not meet technical requirements of the RTTM device will be excluded
- weighing greater than 135 kg
- length of legs below 75 cm or above 100 cm,
- fixed contractures of lower extremity including hip, knee, ankle, or foot).
- Does not have an identified care partner or legally authorized representative to consent to participation
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.