NCT03020433

Brief Summary

The investigators ultimate goal is to personalize brain stimulation for stroke so outcomes of the upper limb can be maximized for each individual patient. Several groups including the investigators have recently theorized that personalizing stimulation so as to selectively stimulate iM1 in mild, and cPMd in patients with greater severity would help generalize benefits of stimulation. The investigator premise that variances in expressions of plasticity can explain how to best stratify patients for robust, personalized stimulation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for early_phase_1 stroke

Timeline
Completed

Started Mar 2016

Typical duration for early_phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

3.8 years

First QC Date

September 6, 2016

Last Update Submit

July 14, 2020

Conditions

StrokeCerebrovascular DisordersNervous System DiseasesBrain DiseasesCardiovascular DiseasesVascular DiseasesCentral Nervous System Diseases

Keywords

Strokerehabrehabilitationparesisparalysisstroke therapyCVAcerebrovascular accidentbrain diseasesTMStranscranial magnetic stimulationCIMTconstraint induced movement therapyMRI

Outcome Measures

Primary Outcomes (1)

  • Aim 1: Change in time (seconds) to perform functional reaching

    Patients will be seated with test arm resting on a table. Three buttons (labeled 1, 2, 3) will be arranged in a semi-circle at 80% of reaching distance of the paretic limb. A number (1, 2, or 3) will cue patients to reach and push the designated button as fast as possible using shoulder flexion-abduction and elbow extension while their trunk is stabilized. Three blocks of 20 trials will be tested pre- and post-rTMS.

    Change in functional reaching from baseline to post rTMS, assessed for approximately 4-6 hours.

Secondary Outcomes (1)

  • Aim 2:Change in plasticity evoked with rTMS.

    Change in neurophysiology from baseline to post rTMS assessed for approximately 4-6 hours.

Study Arms (4)

rTMS Contralesional M1 Inhibition

ACTIVE COMPARATOR
Device: rTMS Contralesional M1

rTMS Contralesional PMC facilitation

ACTIVE COMPARATOR
Device: rTMS Contralesional PMC

rTMS Ipsilesional PMC facilitation

ACTIVE COMPARATOR
Device: rTMS Ipsilesional PMC

rTMS Sham at Ipsilesional M1

SHAM COMPARATOR
Device: rTMS sham at Ipsilesional M1

Interventions

rTMS Contralesional M1DEVICE

1Hz Contalesional M1 repetitive transcranial magnetic stimulation (1500 pulses, 25 minutes, 90% AMT

rTMS Contralesional M1 Inhibition
rTMS Contralesional PMCDEVICE

5Hz Contralesional PMC repetitive transcranial magnetic stimulation (1500 pulses, 10 minutes, 5 trains of 300 pulses each with 1 minute rest in between, 90% AMT)

rTMS Contralesional PMC facilitation
rTMS Ipsilesional PMCDEVICE

5HZ Ipsilesional PMC repetitive transcranial magnetic stimulation (1500 pulses, 10 minutes, 5 trains of 300 pulses each with 1 minute rest in between, 90% AMT)

rTMS Ipsilesional PMC facilitation
rTMS sham at Ipsilesional M1DEVICE

1Hz Ipsilesional M1 sham repetitive transcranial magnetic stimulation (1500 pulses, 25 minutes, 50% MSO)

rTMS Sham at Ipsilesional M1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • greater than 21 years old
  • more than 6 months from first, unilateral index stroke
  • unilateral paresis of the upper limb indexed as greater than or equal to 20% slowness in functional reaching compared to non-paretic limb
  • UEFM less than or equal to 61 out of 66.

You may not qualify if:

  • subjects who cannot perform reaching with shoulder
  • severe cognitive deficit (less than or equal to 24 on Mini-Mental State examination.
  • contraindication to TMS or MRI including: seizures, ongoing use of certain neuro- or psycho-active medications, implants, or pacemaker.
  • currently receiving outpatient therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

StrokeCerebrovascular DisordersNervous System DiseasesBrain DiseasesCardiovascular DiseasesVascular DiseasesCentral Nervous System DiseasesParesisParalysis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ela Plow, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Staff

Study Record Dates

First Submitted

September 6, 2016

First Posted

January 13, 2017

Study Start

March 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

July 16, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)