Trial Outcomes & Findings for Perinatal Stroke: Understanding Brain Reorganization (NCT NCT02743728)

Results Overview

Cortical excitability of ipsilesional and contralesional hemispheres assessed by transcranial magnetic stimulation (TMS) in infants with perinatal stroke. TMS will be used to assess cortical excitability through electromagnetic depolarization of targeted cortical neurons through painless pulses delivered over the scalp. The estimated time of TMS assessment is around 2 hours during Visit 2. Outcome is reported as MEP amplitude in units of microvolts (µV).

Recruitment status

COMPLETED

Target enrollment

20 participants

Primary outcome timeframe

2 hours

Results posted on

2022-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	All Infants Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed. Magnetic Resonance Imaging: Anatomical and Diffusion Tensor Imaging Analysis. Transcranial Magnetic Stimulation: Assessment of brain (cortical) excitability General Movement Assessment: Spontaneous movement assessment of infant while lying in unperturbed state.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Infants n=20 Participants Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed. Magnetic Resonance Imaging: Anatomical and Diffusion Tensor Imaging Analysis. Transcranial Magnetic Stimulation: Assessment of brain (cortical) excitability General Movement Assessment: Spontaneous movement assessment of infant while lying in unperturbed state.
Age, Categorical <=18 years	20 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants
Sex: Female, Male Female	6 Participants n=20 Participants
Sex: Female, Male Male	14 Participants n=20 Participants
Region of Enrollment United States	20 participants n=20 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: Of the 20 enrolled infants, 11 infants participated in TMS. 3 of the 11 infants participated in TMS sessions at two different timepoints; therefore, 14 datasets for TMS outcome measures (MEP amplitude (Outcome 1), Resting Motor Threshold (Outcome 2) were analyzed.

Cortical excitability of ipsilesional and contralesional hemispheres assessed by transcranial magnetic stimulation (TMS) in infants with perinatal stroke. TMS will be used to assess cortical excitability through electromagnetic depolarization of targeted cortical neurons through painless pulses delivered over the scalp. The estimated time of TMS assessment is around 2 hours during Visit 2. Outcome is reported as MEP amplitude in units of microvolts (µV).

Outcome measures

Outcome measures
Measure	All Infants n=14 Participants Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed. Magnetic Resonance Imaging: Anatomical and Diffusion Tensor Imaging Analysis. Transcranial Magnetic Stimulation: Assessment of brain (cortical) excitability General Movement Assessment: Spontaneous movement assessment of infant while lying in unperturbed state.
Cortical Excitability MEP Amplitude (µV)	325 µV Interval 50.0 to 500.0

PRIMARY outcome

Timeframe: 2 hours

Population: Of the 20 enrolled infants, 11 infants participated in TMS. 3 of the 11 infants participated in TMS sessions at two different timepoints; therefore, 14 datasets for TMS outcome measures (MEP amplitude (Outcome 1), Resting Motor Threshold (Outcome 2) were analyzed.

Cortical excitability of ipsilesional and contralesional hemispheres assessed by transcranial magnetic stimulation (TMS) in infants with perinatal stroke. TMS will be used to assess cortical excitability through electromagnetic depolarization of targeted cortical neurons through painless pulses delivered over the scalp. The estimated time of TMS assessment is around 2 hours during Visit 2. The outcome of motor threshold will be reported as the percentage of maximum stimulator output.

Outcome measures

Outcome measures
Measure	All Infants n=14 Participants Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed. Magnetic Resonance Imaging: Anatomical and Diffusion Tensor Imaging Analysis. Transcranial Magnetic Stimulation: Assessment of brain (cortical) excitability General Movement Assessment: Spontaneous movement assessment of infant while lying in unperturbed state.
Cortical Excitability Percentage of Maximum	70 %MSO Interval 50.0 to 95.0

SECONDARY outcome

Timeframe: 15 minutes

Population: Of the 20 enrolled infants, 12 were able to complete the General Movements Assessment (GMA). The GMA was only completed if infants were between 3-5 months of age at the time of enrollment.

Movement quality will be assessed by general movement assessment (GMA). GMA requires 5-10 minutes videotaping when infants are placed in spine position for scoring. Infants are scores categorically as typical (present fidgety movements) or atypical (absent, sporadic, or abnormal fidgety movements). Outcome is reported as the number of typical infants and number of atypical infants.

Outcome measures

Outcome measures
Measure	All Infants n=12 Participants Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed. Magnetic Resonance Imaging: Anatomical and Diffusion Tensor Imaging Analysis. Transcranial Magnetic Stimulation: Assessment of brain (cortical) excitability General Movement Assessment: Spontaneous movement assessment of infant while lying in unperturbed state.
General Movement Assessment Typical	8 Participants
General Movement Assessment Atypical	4 Participants

SECONDARY outcome

Timeframe: 2 days

Population: Of the 20 enrolled infants, 13 infants participated in either MRI or TMS (during which adverse events were recorded).

Recording of adverse events will take place during TMS cortical mapping and MRI scanning of infants with perinatal stroke. Assessment of vital signs changes and pain/stress responses during both MRI and TMS assessment during visit 1 and visit 2. Outcome is reported as the number of adverse events recorded.

Outcome measures

Outcome measures
Measure	All Infants n=13 Participants Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed. Magnetic Resonance Imaging: Anatomical and Diffusion Tensor Imaging Analysis. Transcranial Magnetic Stimulation: Assessment of brain (cortical) excitability General Movement Assessment: Spontaneous movement assessment of infant while lying in unperturbed state.
Adverse Events	0 # Adverse Events

SECONDARY outcome

Timeframe: 15 minutes

Population: Of the 20 enrolled infants, 6 infants participated in remote follow-up and were assessed with the PEDI-CAT.

The PEDI-CAT uses Item Response Theory statistical models to estimate a child's ability from a minimal number of items. Three functional domains will be assessed. The PEDI-CAT software provides normative standard scores presented as T scores and age percentile ranges to assess daily activities, mobility, and social/cognitive function. Outcome is reported as the mean score generated by the PEDI-CAT software. Scores are based on t-test values and do not have a unit of measure or a defined range. Higher scores indicate greater deviation from the standardized mean score.

Outcome measures

Outcome measures
Measure	All Infants n=6 Participants Each infant will receive an Magnetic Resonance Imaging, then Transcranial Magnetic Stimulation Cortical Excitability testing, and General Movement Assessment. These 3 different components of the one arm in which all infants are involved will be collectively assessed. Magnetic Resonance Imaging: Anatomical and Diffusion Tensor Imaging Analysis. Transcranial Magnetic Stimulation: Assessment of brain (cortical) excitability General Movement Assessment: Spontaneous movement assessment of infant while lying in unperturbed state.
Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) Daily Activities	46 normative age percentiles Interval 1.0 to 87.0
Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) Mobility	42 normative age percentiles Interval 1.0 to 78.0
Pediatric Evaluation of Disability Inventory Computer Adaptive Test (PEDI-CAT) Social/Cognitive	38 normative age percentiles Interval 2.0 to 62.0

Adverse Events

All Infants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bernadette Gillick

University of Minnesota

Phone: 612-626-5898

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place