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Spastic ParaplegiaPhase 4NCT07803276

Comparison Between Palpatory and Ultrasound-guided Methods for Botulinum Toxin Administration in Spastic Paraplegia

A Phase 4 study testing AbobotulinumtoxinA - Ultrasound-Guided Technique and AbobotulinumtoxinA - Conventional Technique in people with Spastic Paraplegia, run by Universidade Federal Fluminense at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Spasticity in spastic paraplegia is a major cause of chronic pain and functional limitation. Although botulinum toxin type A (BoNT-A) reduces muscle tone, studies like the SPASTOX trial have shown limited functional improvement, which may be related to injection accuracy in deep or complex muscle groups. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spastic Paraplegia
What is being tested?
AbobotulinumtoxinA - Ultrasound-Guided Technique and AbobotulinumtoxinA - Conventional Technique
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteBrazil
Study dates
22 Apr 2026to May 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 18 years
  • Clinical diagnosis of spastic paraplegia
  • Spasticity with Ashworth Scale score between 2 and 3 in at least one muscle group with indication for botulinum toxin treatment
  • Muscle strength ≥ 3 on the Muscle Strength Assessment Scale
  • Enrollment in a rehabilitation program
  • For women of childbearing potential, a negative beta-hCG test at the time of injection

Who cannot join

  • Concomitant neuromuscular disorders
  • History of hypersensitivity to botulinum toxin
  • Active infection at the injection site
  • Ashworth Scale score of 4
  • Pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bruna de Oliveira, MD contact

5521999200801

b_andrade@id.uff.br

Brazil1 site, 1 recruiting

  • Instituto de Neurologia Deolindo Couto

    Rio de Janeiro, Rio de Janeiro, 22290-140

    Bruna de Oliveira, 5521999200801, b_andrade@id.uff.br

    Recruiting

Other trials in Brazil

About this study

Spasticity in spastic paraplegia is a major cause of chronic pain and functional limitation. Although botulinum toxin type A (BoNT-A) reduces muscle tone, studies like the SPASTOX trial have shown limited functional improvement, which may be related to injection accuracy in deep or complex muscle groups. Ultrasound guidance enhances injection precision, potentially improving clinical outcomes. This prospective, single-group, fixed-sequence crossover study ($N = 40$) aims to compare the response to BoNT-A in patients with spastic paraplegia (all etiologies included). Participants will receive treatment in two distinct phases separated by a 16-week washout period: first with conventional anatomical landmark-guided injections, followed by ultrasound-guided injections. A fixed sequence (anatomical first, ultrasound second) is used to prevent observer bias, ensuring the injector remains blinded to muscle ultrasound features (e.g., fatty infiltration or fibrosis) during the landmark-guided phase. Both the participants and the outcome assessor are blinded to the application sequence. Assessments will occur before and 4 weeks after each intervention using validated tools, including the Modified Ashworth Scale, Goal Attainment Scaling (GAS), Timed Up and Go (TUG), Visual Analog Scale (VAS) for pain, modified Barthel Index, SF-36 questionnaire, and the Heckmatt scale. The hypothesis is that ultrasound-guided injections will achieve greater spasticity reduction and functional recovery.

Being tested
AbobotulinumtoxinA - Ultrasound-Guided Technique, AbobotulinumtoxinA - Conventional Technique
Keywords
botulinum toxin, spastic paraplegia
Medical subject headings
Paraplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbobotulinumtoxinA - Ultrasound-Guided TechniqueDrug

    Administration of AbobotulinumtoxinA (500U) into spastic lower limb target muscles under real-time ultrasound guidance to ensure precise muscle localization. Performed 16 weeks after the first intervention. Assessments are performed pre-injection and 4 weeks post-injection

  • AbobotulinumtoxinA - Conventional TechniqueDrug

    Administration of AbobotulinumtoxinA (500U) into spastic lower limb target muscles using standard anatomical landmarks and manual palpation. Assessments are performed at baseline and 4 weeks post-injection.

Study groups in NCT07803276
Study groupRoleWhat they receive
Spastic Paraplegia Cohort (Anatomical Toxin Injection followed by USG-Guided Injection)ExperimentalParticipants with spastic paraplegia receive two sequential treatments separated by a 16-week washout period: First intervention: AbobotulinumtoxinA injection using the conventional anatomical/palpation technique. Washout period: 16 weeks. Second intervention: AbobotulinumtoxinA injection using the ultrasound-guided technique
Receives: Drug: AbobotulinumtoxinA - Ultrasound-Guided Technique; Drug: AbobotulinumtoxinA - Conventional Technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in spasticity after BoNT-A injection techniques

    Change in spasticity measured by the Modified Ashworth Scale (MAS), comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections in patients with spastic paraplegia. The Modified Ashworth Scale ranges from 0 to 4, with higher scores indicating greater muscle tone/spasticity (worse outcome)

    Measured: Baseline and 4 weeks after each injection session

  2. Functional improvement assessed by Goal Attainment Scaling

    Functional improvement assessed by Goal Attainment Scaling (GAS) after conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections.

    The Goal Attainment Scaling score ranges from -2 to +2, with higher scores indicating greater achievement of the predefined treatment goals (better outcome)

    Measured: Baseline and 4 weeks after each intervention

  3. Functional mobility assessed by the Timed Up and Go Test

    Change in functional mobility measured by the Timed Up and Go (TUG) Test, comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections.

    The Timed Up and Go Test is measured in seconds, with lower times indicating better functional mobility (better outcome)

    Measured: Baseline and 4 weeks after each intervention

  4. Change in functional independence assessed by the Modified Barthel Index

    Change in functional independence measured by the Modified Barthel Index, comparing conventional landmark-guided versus ultrasound-guided botulinum toxin type A injections.

    The Modified Barthel Index ranges from 0 to 100, with higher scores indicating greater functional independence (better outcome).

    Measured: Baseline and 4 weeks after each intervention

Secondary outcomes (3)

  1. Pain intensity after BoNT-A injection techniques

    Change in pain intensity measured by the Visual Analog Scale (VAS). The Visual Analog Scale ranges from 0 to 10, with higher scores indicating greater pain intensity (worse outcome)

    Measured: Baseline and 4 weeks after each intervention

  2. Quality of life after BoNT-A injection techniques

    Change in quality of life assessed by the 36-Item Short Form Health Survey (SF-36).

    The SF-36 assesses eight health domains, with scores ranging from 0 to 100 for each domain. Higher scores indicate better health status (better outcome)

    Measured: Baseline and 4 weeks after each intervention

  3. Adverse events related to BoNT-A injection techniques

    Incidence and severity of adverse events associated with conventional landmark-guided and ultrasound-guided botulinum toxin type A injections

    Measured: Up to 16 weeks after each injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2026
  2. Study start22 Apr 2026
  3. Primary completionFeb 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Crossover Assignment - with a fixed sequence: botulinum toxin administration using the anatomical method followed by the ultrasound-guided method.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07803276
Sponsor's protocol ID
90758725.3.0000.5243
Status last verified
Jun 2026
First submitted
24 Aug 2026
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing AbobotulinumtoxinA - Ultrasound-Guided Technique and AbobotulinumtoxinA - Conventional Technique in people with Spastic Paraplegia, run by Universidade Federal Fluminense at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bruna de Oliveira, MD (5521999200801, b_andrade@id.uff.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in spasticity after BoNT-A injection techniques (time frame: Baseline and 4 weeks after each injection session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07803276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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