Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05417009 |
Other study ID # |
314067 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 26, 2023 |
Est. completion date |
July 21, 2023 |
Study information
Verified date |
August 2023 |
Source |
Queen Mary University of London |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Autonomic modulation by transcutaneous vagal nerve stimulation in acute ischaemic stroke
requiring mechanical thrombectomy: a phase IIa, sham controlled randomised trial.
Description:
Loss of autonomic variability is strongly associated with adverse outcomes after ischaemic
stroke. Removing blood clots from the brain by mechanical thrombectomy has revolutionised the
management of stroke, but more than 50% of patients do not regain functional
independence.(PMID:26898852) Blood pressure (BP) control is important, since low and high BP
(BP variability) are strongly associated with poor patient outcomes after thrombectomy.
(PMIDs:32961389;31964286) Autonomic dysfunction causes labile blood pressure. Intact
autonomic function is required to control blood pressure and potentially improve recovery
after stroke. Impairment of baroreflex autonomic function, due to reduced vagal activity is
associated with extreme BP variability, leading to further brain injury and cardiovascular
complications.(PMID:30371208) Reduced baroreflex control is related to poor patient outcomes
after stroke, independent of absolute blood pressure.(PMID:19834010) Reversing baroreflex and
vagal dysfunction is, therefore, widely held to have the potential to improve cardiovascular
control and patient outcome in this context.(PMID:19834010)
Non-invasive peripheral neuromodulation restores autonomic control. Vagal nerve stimulation
improves autonomic control and reverses baroreflex dysfunction (PMIDs:28949064) but this has
previously required surgically implanted devices which are expensive and impractical in the
context of acute stroke. Afferent Electronic have achieved the same effect as these
implantable devices by non-invasive transcutaneous autonomic neuromodulation (TAN). We have
used this simple, safe, hand-held, low-cost device to increase vagal activity and baroreflex
sensitivity through non-invasive, painless stimulation of nerves located in the outer ear to
control blood pressure.
Baroreflex sensitivity can be increased at the bedside by TAN for 30 minutes following acute
trauma. If this can be replicated in thrombectomy patients, it will aid recovery and
rehabilitation through five complementary mechanisms where it has been clinically
demonstrated that increasing vagal nerve activity:
1. Restore baroreflex sensitivity;
2. Increase blood flow to ischaemic brain tissue through vagal activation.(PMID:27357059)
3. Dampen cerebral/systemic inflammation.(PMID:26723020);
4. Reduce atrial fibrillation and myocardial injury,(PMIDs:5744003,22739118) which are
common after stroke, and independently predict cognitive decline and cardiovascular
mortality
5. Allows immediate commencement of vagal nerve stimulation, which has recently been shown
to enhance upper-limb rehabilitation.(PMID:33894832) Our proof-of-concept data shows
daily TAN reduces BP and BP variability lasting several months even in drug-resistant
hypertensive patients. In this proof-of-concept randomised sham-controlled trial, we
will examine whether early TAN on presentation for mechanical thrombectomy improves
autonomic function in patients with acute ischaemic stroke by reducing blood pressure
lability.