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New combo therapy may cut muscle stiffness and botox doses for stroke survivors

NCT ID NCT07440173

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

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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