Early Use of Botulinum Toxin in Spasticity Post Stroke.
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
Patients who survive a stroke are often left with an arm that cannot be used. One reason for
this is that the muscles affected by the stroke become overactive. This is known as
spasticity. Such unwanted muscle overactivity, if left untreated or poorly managed, can lead
to limb deformities. For example, the wrist and fingers in the arm affected by spasticity
become stiff and curl into a fist and the hand cannot be used for any functional purpose.
Palm hygiene can become difficult and patients find this deformity unsightly and painful.
Botulinum toxin (BT) has been shown to reduce muscle overactivity and is licensed for this
purpose. In current practice this treatment is often used as a last line of defence. Although
BT can reduce the muscle overactivity, when injected using current protocols, it seems to
have little impact on the recovery of function and/or treating the limb deformities and pain.
If BT can be given in the early stages of a stroke, i.e. as soon as the muscle overactivity
is observed, then we will be able to treat spasticity and may prevent the limb deformities
and pain from developing. We may also be able to assist the recovery of arm movement in some
of the patients who would otherwise not have regained this. In addition to benefiting the
patient, the prevention of secondary complications by early treatment may reduce the costs of
long term care to the NHS . We hope to discover if our plan of providing early treatment with
BT is more effective than the current approach. If we demonstrate that the treatment is
effective we will be able to introduce this new method almost immediately within the NHS
through our collaboration with doctors and therapists who are actively treating patients with
this condition.
Phase:
Phase 2
Details
Lead Sponsor:
Sandwell & West Birmingham Hospitals NHS Trust
Collaborators:
Keele University Stroke Research Network
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA