Menu
Not yet recruiting NCT04830163

Brain State-dependent PCMS in Chronic Stroke

Phase I / Phase II Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Brain state-dependent paired corticomotoneuronal stimulation (PCMS).
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Upregulating Corticospinal Function After Stroke Using Brain State-dependent Paired Corticomotoneuronal Stimulation

Overview

After stroke, people often have difficulty using their hands. Combined brain and nerve stimulation can strengthen the neural pathways that control hand function. In this study, we will deliver combined brain and nerve stimulation during specific time windows that increase activation of neural pathways underlying hand function. We will compare the effects of combined brain and nerve stimulation during these optimal time windows to the effects of combined brain and nerve stimulation applied during random time windows on post-stroke hand function.

Interventions

  • Combination product Brain state-dependent paired corticomotoneuronal stimulation (PCMS)
    Paired corticomotoneuronal stimulation (PCMS) involves delivering precisely timed pairs of transcranial magnetic stimulation (TMS) and peripheral nerve stimulation (PNS) so that the neuronal activity evoked by such stimulation arrives synchronously at corticospinal-motoneuronal synapses. This synchronous arrival is postulated to cause long-term potentiation via spike timing-dependent plasticity, which then improves corticospinal transmission and hand function. In this study, paired corticomotone

Primary outcome measures

  • Maximum hand force output [Time frame: up to 1 hour after intervention]
  • Maximum hand muscle activation [Time frame: up to 1 hour after intervention]
Secondary outcome measures (2)
  • Amplitude of motor evoked potentials [Time frame: up to 1 hour after intervention]
  • Time to complete the 9-hole peg test [Time frame: up to 1 hour after intervention]

Eligibility criteria

Inclusion criteria

  • History of stroke > 6 months ago
  • Presence of residual upper extremity hemiparesis
  • Willingness to participate
  • Ability to provide informed consent
  • Upper extremity Fugl-Meyer score < 66
  • Mini Mental State Exam score > 24
  • Discernible and reliable motor-evoked potential (MEP) elicited following single-pulse TMS to the lesioned hemisphere

Exclusion criteria

  • History of neurological disease other than stroke
  • Presence of contraindications to transcranial magnetic stimulation (TMS) or peripheral nerve stimulation (PNS), including: history of adverse reactions to TMS or PNS metal in head, eyes, neck, chest/trunk, or arms, including but not limited to shrapnel, surgical clips, fragments from metalworking, fragments from welding, implanted device, history of frequent and severe headaches or migraines, immediate family history of seizure or epilepsy, personal history of seizure or epilepsy, current, suspected, or planned pregnancy, current or recent (within the last 3 months) use of medications acting on the central nervous system other than selective serotonin reuptake inhibitors (SSRIs), including but not limited to antipsychotic drugs, benzodiazepines, prescription stimulants.
  • Upper extremity Fugl-Meyer score ≥ 66 (66 is the maximum on this scale)
  • Mini Mental State Exam score <= 24
  • No discernible and reliable MEP elicited following single-pulse TMS to the lesioned hemisphere

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Texas at Austin — Austin

Identifiers

NCT: NCT04830163 · STUDY00000896_Exp3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗