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Chronic PainCLONUSNCT06384170

Closed Loop Spinal Cord Stimulation for Neuromodulation of Upper Motor Neuron Lesion Spasticity

An observational study of Chronic Pain and Spasticity as Sequela of Stroke, run by Johns Hopkins University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Spasticity is characterized by increased muscle tension and is a classic consequence of upper motor neuron (UMN) damage in the central nervous system, such as from stroke or trauma. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Spinal Cord Stimulation- Closed loop
Type of treatment
Medical device
How many people
0 participants
Where
1 siteUnited States
Study dates
3 Dec 2024to May 2026
Phase
Observational
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: A subject who meets all of the inclusion criteria, and none of the exclusion criteria, is eligible to participate in the study. A subject is considered enrolled when the subject signs the subject informed consent form.

Who may be able to join

  • First-ever stroke
  • Aged 18 and older
  • Neuropathic pain >3 months (chronic)
  • Brain injury associated with spasticity in one or multiple limbs >3 months post-stroke
  • No previous history of neuropathic pain or spasticity in affected limbs
  • Cognitively capable to operate the SCS system

Who cannot join

  • Inadequate Pain Severity: Patients with mild or non-debilitating pain may be excluded if the treatment is intended for individuals with moderate to severe pain.
  • Previous SCS Implantation: Patients who have previously undergone SCS implantation may be excluded to focus on those who are new to the therapy.
  • Inadequate Pain Duration: Some trials may exclude patients whose pain has not persisted for a minimum period to ensure that the pain condition is chronic.
  • Medical Comorbidities: Patients with certain medical conditions or comorbidities that may increase the risks associated with SCS, such as uncontrolled cardiovascular disease, uncontrolled diabetes, or active infections, may be excluded.
  • Psychological Factors: Patients with severe psychiatric disorders or psychological conditions that may interfere with the assessment of pain or the ability to provide informed consent may be excluded.
  • Allergies or Sensitivities: Patients with allergies to materials used in SCS devices or contraindications to the anesthesia used during implantation may be excluded.
  • Substance Abuse: Patients with active substance abuse or addiction issues may be excluded due to concerns about treatment compliance and efficacy.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Closed Loop Spinal Cord Stimulation (SCS) for Neuromodulation of UMN-Lesion Spasticity

Spasticity is characterized by increased muscle tension and is a classic consequence of upper motor neuron (UMN) damage in the central nervous system, such as from stroke or trauma. Clinically, it presents as muscle resistance to passive stretching, along with clasp-knife rigidity, clonus, increased tendon reflexes, and muscle spasms. An imbalance of the descending inhibitory and muscle stretch reflexes is thought to be the cause of spasticity. Post-stroke spasticity is a common condition that occurs in 37.5-45% of cases in the acute stage and 19-57.4% in the subacute stage after a stroke. At 6 months post-stroke, spasticity develops in 42.6-49.5% of cases, and at one year, it affects 35-57.4% of individuals. In patients with cerebral palsy (CP), incidence is almost 80% while in those living with spinal cord injury the number approaches up to 93%. Traumatic brain injury (TBI) patients have a higher prevalence on initial admission to neurorehabilitation but one in three patients will have chronic spasticity. However, the Defense and Veterans Brain Injury Center report a rate of TBIs amongst deployed veterans to be around 11-23% mostly from blast and explosive trauma.

There have been studies as early as the 1980s exploring the efficacy of SCS for spasticity control, however, the credibility of many of these studies is constrained due to an incomplete comprehension of spasticity's underlying mechanisms, outdated research methods, and early limitations in implantable device technology. Intrathecal pumps for baclofen have remained as the mainstay for refractory spasticity, however, it comes with associated risks such as chemical dependence leading to acute baclofen withdrawal and requiring frequent refill requirement. Most importantly, it does not yield functional improvement of muscle activity, just suppression of spasticity. Botox is also routinely used but due to heterogeneity in muscle involvement as well as variability in provider skill, results may be inconsistent and short-lasting, requiring frequent clinic visits for repeat injections to the affected muscle groups. SCS may be able to address that gap in spasticity management.

Being tested
Spinal Cord Stimulation- Closed loop
Keywords
Spinal Cord Stimulation, Neuromodulation, Closed-loop SCS, Post-Stroke Pain, Spasticity, Chronic Pain, Functional Recovery
Medical subject headings
Chronic Pain, Muscle Spasticity

What participants receive

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

  • Spinal Cord Stimulation- Closed loopDevice

    This is a percutaneously placed epidural electrode that is connected to a battery-powered impulse generator for power. The electrical delivery is monitored in real-time with the measurement of evoked compound action potentials and adjusted to provide titration of therapeutic stimulation delivery.

Study groups in NCT06384170
Study groupRoleWhat they receive
InterventionalPatients identified with post-stroke pain due to spasticity. Patients will be evaluated for spinal cord stimulation trial. The trial will be for 7 days.
Receives: Device: Spinal Cord Stimulation- Closed loop

What is being measured

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

  1. Pain as assessed by Visual Analog Score

    Visual Analog Scores, pain score with possible range from zero (no pain) to ten (worst imaginable pain)

    Measured: baseline (pre-procedure), day 1 (post-procedure) day 7 (trial lead removal), day 14 (7 days post removal)

Secondary outcomes (4)

  1. Spasticity Reduction as assessed by the Modified Ashworth's Score

    Modified Ashworth's Scores range from 0-4. Minimum score is '0' meaning no increase in tone. Maximum score is '4' meaning limb is ridged in flexion and extension. The lower the score the better the outcome

    Measured: baseline (pre-procedure), day 1 (post-procedure) day 7 (trial lead removal), day 14 (7 days post removal)

  2. Short Form 36 Health Survey (SF-36) score

    The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. The total score on the SF-36 ranges from 0 - 100 Lower scores = more disability, higher scores = less disability

    Measured: baseline (pre-procedure), day 1 (post-procedure) day 7 (trial lead removal), day 14 (7 days post removal)

  3. Medication Use

    Dose and frequency of medication use for current symptoms

    Measured: baseline (pre-procedure), day 1 (post-procedure) day 7 (trial lead removal), day 14 (7 days post removal)

  4. Health Status as assessed by the EuroQol 5 Dimension 5 Level (EQ-5D-5L)

    Effects on health-related quality of life that comprises five dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The survey is scored in two separate sections. The first section is measured by a minimum score of 5 and a maximum score of 25. Higher score greater level of problems. The second section measures self report health status on a 0 to 100. Higher score best health.

    Measured: baseline (pre-procedure), day 1 (post-procedure) day 7 (trial lead removal), day 14 (7 days post removal)

Timeline

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

  1. First posted25 Apr 2024
  2. Study start3 Dec 2024
  3. Primary completionJan 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Why it stopped: The study will not move forward; lack of staff

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06384170
Sponsor's protocol ID
IRB00442113
Acronym
CLONUS
Status last verified
Feb 2026
First submitted
22 Apr 2024
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Mayorova L, Radutnaya M, Varyukhina M, Vorobyev A, Zhdanov V, Petrova M, Grechko A. Immediate Effects of Anti-Spastic Epidural Cervical Spinal Cord Stimulation on Functional Connectivity of the Central Motor System in Patients with Stroke- and Traumatic Brain Injury-Induced Spasticity: A Pilot Resting-State Functional Magnetic Resonance Imaging Study. Biomedicines. 2023 Aug 14;11(8):2266. doi: 10.3390/biomedicines11082266.

    PubMed 37626762

  • Powell MP, Verma N, Sorensen E, Carranza E, Boos A, Fields DP, Roy S, Ensel S, Barra B, Balzer J, Goldsmith J, Friedlander RM, Wittenberg GF, Fisher LE, Krakauer JW, Gerszten PC, Pirondini E, Weber DJ, Capogrosso M. Epidural stimulation of the cervical spinal cord for post-stroke upper-limb paresis. Nat Med. 2023 Mar;29(3):689-699. doi: 10.1038/s41591-022-02202-6. Epub 2023 Feb 20.

    PubMed 36807682

  • Abstracts of Scientific Papers and Posters Presented at Physiatry '25: February 25 - March 1, 2025. Am J Phys Med Rehabil. 2025 Jun 1;104(6S Suppl 1):S1-S240. doi: 10.1097/PHM.0000000000002746. No abstract available.

    PubMed 40421840

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain and Spasticity as Sequela of Stroke, run by Johns Hopkins University at 1 site in United States.

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 7 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: withdrawn, as of the sponsor's last update on 6 Feb 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 United States. 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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain as assessed by Visual Analog Score (time frame: baseline (pre-procedure), day 1 (post-procedure) day 7 (trial lead removal), day 14 (7 days post removal)). 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 NCT06384170, which also lists 3 linked publications.

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 6 Feb 2026.

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