Health TrialsbyHealthPanel

kTMP-Enhanced Motor Rehabilitation for Chronic Stroke Recovery (KULMINATE) Pilot

ConditionsStrokeChronic Stroke PatientsArm Weakness as a Consequence of Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMagnetic Tides

About this trial

kTMP, kilohertz transcutaneous magnetic perturbations, is a low intensity transcranial magnetic stimulation technique that will be used in this study to promote arm/hand rehabilitation in patients who have been disabled by stroke.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18-80 years who have a history of an ischemic or hemorrhagic stroke ≥ 12 m prior to enrollment.

Fugl-Meyer Assessment: Upper Extremity (FMA UE) score 20-50.

Ability to communicate, understand, and give appropriate consent. Participants can follow two-step commands.

Motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse TMS (MEP positive).

Disqualifiers

Participants with moderate or severe cognitive impairment (MoCA < 18).

Participants with sensory deficits FMA-S < 6/12 (with proprioception < 4/8).

Participants with severe apraxia (TULIA < 5).

Language impairment or behavioral disorder that interferes with their ability to adhere to the protocol or to provide informed consent.

Trial design

Design model

Parallel

Treatments tested in this trial

  • kTMP

    Device

    A new non-invasive brain stimulation tool

  • Sham kTMP

    Device

    A new non-invasive brain stimulation tool with sham setting selected

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Active kTMPExperimental treatment 1 intervention
Group B: Sham kTMPSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Range of Joint Motion (ROM)

defined as the standard deviation of the joint angle time series for a given trial. The median ROM will be calculated for eleven degrees of freedom and then averaged. If there are joints which appear to be compensatory, they will be removed from the analysis

Time frame
6 weeks

Secondary outcomes

1

Fugl- Meyer Assessment (Upper Extremity)

A comprehensive clinical examination that has been widely used to evaluate stroke-related motor impairment. It is graded from 0 (hemiplegia) to 66 for the Upper extremity. Higher scores signifies better motor control, and hence a better outcome.

Time frame
6 weeks
2

Modified Ashworth Scale (MAS)

Used to measure spasticity in wrist and hand flexors and extensors. It assigns a grade of spasticity from 0-4. Lower scores represent normal muscle tone and higher scores represent spasticity. Hence lower scores are associated with better outcomes.

Time frame
6 weeks
3

Transport Time

Calculated for each of three epochs, pre, during and post

Time frame
6 weeks
4

Trial to Trial Variability (T2TV)

Defined as the mean-squared error between the joint angle time-series for a given trial and the median joint angle timeseries. The median T2TV will be calculated for eleven degrees of freedom.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Magnetic Tides

Lead sponsor

University of California, San Francisco

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Source ClinicalTrials.gov
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