New combo therapy may cut muscle stiffness and botox doses for stroke survivors
NCT ID NCT07440173
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two treatments for arm stiffness after stroke: a combination of phenol injections for large muscles plus botox for smaller muscles, versus botox alone. Sixty adults who had a stroke at least six months ago will take part. The goal is to see if the combined approach reduces stiffness just as well or better, while possibly lowering the amount of botox needed.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* Inclusion criteria : * Adults aged 18 to 70 years. * Diagnosis: Documented Ischemic or Hemorrhagic stroke (with a duration of at least 6 months post-stroke to ensure a chronic, stable phase). * Spasticity Severity: A score of 2 on the Modified Ashworth Scale (MAS) in at least one proximal muscle group (Shoulder adductors or Elbow flexors). * Functional Status: Evidence of upper limb motor impairment but with enough stability to participate in follow-up. * Cognitive Ability: Ability to understand and follow instructions (Mini-Mental State Examination score typically 24) to ensure cooperation during TMS and functional testing. * Consent: Signed informed consent provided by the patient or a legal guardian. * Exclusion Criteria : * Fixed Contractures: Any permanent joint deformity or fixed contracture in the target limb that would prevent range of motion improvement. * Prior Treatment: Received Botulinum Toxin or phenol injections in the affected limb within the last 6 months. * TMS Contraindications: History of seizures. * Presence of metallic implants in the head or neck (e.g., clips, shunts). * Cardiac pacemakers or implanted medication pumps. * Local Factors:Skin infection or inflammation at the planned injection sites. * Medical Co-morbidities: Significant peripheral nerve disease (other than the stroke-related upper motor neuron lesion) or severe psychiatric disorders. * Phenol Sensitivity: Known hypersensitivity to phenol or its derivatives.
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As listed by the trial registrant
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How to take part
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The official record
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A doctor treating you
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More trials for these conditions
Other studies related to the condition(s) this trial covers.
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