A Phase 1/2 interventional study of Active RAVANS concurrent with arm motor training and Inactive RAVANS concurrent with arm motor training in Stroke and Upper Extremity Paresis, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-21.
Sponsored by Massachusetts General Hospital · Phase 1/2, Interventional, and Treatment
Among 10 studies in Stroke by Massachusetts General Hospital — 4 open to participants now, 4 under way, none of them phase 3. Stroke · Massachusetts General Hospital.
Among the 10 studies in Stroke by Massachusetts General Hospital, this one is the only one that started in 2018, is the only one in phase 1/2, and was the 3rd registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 6 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →4 of the 10 studies in Stroke by Massachusetts General Hospital are open now, in 1 country. Each count lists the studies.
Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 1985; this study’s year is marked. 1 started in 2018.
Median enrollment 50 across the 7 interventional studies, 375 across the 2 observational. Of the 4 that completed or were terminated, 2 (50%) have results posted.
Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
1 of the studies in Stroke by Massachusetts General Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07414732Massachusetts General HospitalTesting the Effectiveness of a Novel Intervention to Improve Medication Adherence in Stroke Survivors | 2027-04-30 |
Among the 10 studies in Stroke by Massachusetts General Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
This study will evaluate the safety and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 intervention sessions occurring daily for 30 minutes over 2 weeks. The safety and improvements in arm motor function after the intervention will be compared in patients receiving RAVANS to those receiving sham stimulation.
This study will evaluate the safety, feasibility and effectiveness of Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for improving motor recovery after stroke. Subacute stroke patients will be randomized to RAVANS or sham stimulation groups. Patients will receive RAVANS or sham stimulation concurrent with arm motor training during 10 sessions occurring daily for 30 minutes over 2 weeks. Safety will be compared in patients receiving RAVANS to those receiving sham stimulation. Feasibility will be evaluated by recruitment into the study and retention of enrolled patients. Changes in arm motor function will be compared between RAVANS and sham stimulation groups from baseline to immediately after the intervention period and to function at 3-months after stroke.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Active RAVANS concurrent with arm motor training
Device: Inactive RAVANS concurrent with arm motor training
Patient receives non-painful, sensory-level stimulation to the skin of left outer ear, where nerve endings of the auricular branch of the vagus nerve reside, while participating in arm motor training
Patient does not receive stimulation delivered to the skin of left outer ear while participating in arm motor training
Upper extremity motor impairment
Change in upper extremity subtest of Fugl Meyer Assessment (FMA-UE) score
Time frame: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Upper extremity motor function
Change in Action Research Arm Test (ARAT) score
Time frame: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Grip force control
Change in accuracy, variability and temporal structure of performance on a grip force control task
Time frame: Baseline to just after 10 intervention sessions, and baseline to 3 months post-stroke
Upper extremity disability
Change in hand subtest of Stroke Impact Scale (SIS-hand) score
Time frame: Baseline to 3 months post-stroke
Mood state, anxiety and depression
Change in Hospital Anxiety and Depression Scale (HADS) scores
Time frame: Baseline to 3 months post-stroke
Ran from May 2018 to primary completion in Nov 2018, 6 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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