A Novel Approach for Brain Stimulation in Severe Stroke

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2023-07-13

Brief Summary

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The long-term goal of this project is to develop upper limb rehabilitation interventions that can be utilized for stroke survivors, specifically survivors with more severe limitations in use of their affected upper limb.

This study will utilize a novel method of non-invasive brain stimulation in conjunction with upper limb training given for 12 visits over a period of 6 weeks.

The study will include the following site visits:

* Eligibility Screening and Informed Consent Visit
* An MRI visit
* Two testing visits in which motor function of the upper limb and neurophysiology will be measured
* 12 intervention visits during which patients will receive upper limb training in conjunction with non-invasive brain stimulation
* Repeat testing of motor function of the upper limb and neurophysiology
* Repeat MRI testing
* A follow-up visit completed 3 months after the completion of interventions

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Detailed Description

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In a pilot, randomized clinical trial, 24 stroke patients with moderate/severe impairments will receive non-invasive brain stimulation (repetitive Transcranial Magnetic Stimulation or rTMS) to one of two targets in the brain in conjunction with upper limb training for 2 days a week for 6 weeks. The primary outcome will be upper limb motor impairment, and secondary outcomes will be tests of functional abilities, proximal motor control, and patient-reported disability. Associated neural mechanisms will also be studied using neurophysiological and functional connectivity MRI techniques. Damage to ipsilesional corticospinal pathways will be indexed with diffusion tensor imaging (DTI).

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

In a pilot, randomized, assessor-blind clinical trial, an anticipated 24 patients will be assigned to either receive stimulation to a new brain target- contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere- or the conventional brain target- ipsilesional primary motor cortex (iM1) located in the stroke hemisphere. Stimulation will be delivered in conjunction with rehabilitation for 2 days a week for 6 weeks.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Subjects will be told they will receive brain stimulation, but will be given no indication as to which target will be stimulated. Investigators analyzing functional outcome data, neurophysiology data and MRI data will receive coded data that conceals the identity of the subject.

Study Groups

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Contralesional dorsal premotor cortex (cPMD) rTMS + Training

New Approach

Group Type ACTIVE_COMPARATOR

New Repetitive Magnetic Stimulation (rTMS) Approach

Intervention Type DEVICE

Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.

Ipsilesional Primary Motor Cortex (iM1) rTMS + Training

Conventional Approach

Group Type ACTIVE_COMPARATOR

Conventional Repetitive Magnetic Stimulation (rTMS) Approach

Intervention Type DEVICE

Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.

Interventions

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New Repetitive Magnetic Stimulation (rTMS) Approach

Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.

Intervention Type DEVICE

Conventional Repetitive Magnetic Stimulation (rTMS) Approach

Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be stimulated with high-frequency rTMS (5-Hz) using 42 10-sec trains of 50 pulses each (total 2100 pulses) for a period of 24 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 2 days a week for 6 weeks, i.e., for a total of 12 sessions.

Intervention Type DEVICE

Other Intervention Names

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Contralesional dorsal premotor cortex (cPMD) rTMS + Training Ipsilesional Primary Motor Cortex (iM1) rTMS + Training

Eligibility Criteria

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Inclusion Criteria

* chronic phase (≥6 months) after index stroke
* moderate or severely impaired (UEFM ≤42)
* have either extensive damage to ipsilesional pathways (MEP-), or, have one of the following: less than 10 degrees active wrist extension, less than 10 degrees active thumb extension/abduction, less than 10 degrees active extension in at least 2 additional digits (i.e. will not meet minimum Constraint-Induced Movement Therapy \[CIMT\] criteria).
* medically stable

Exclusion Criteria

* cerebellar stroke
* brainstem stroke
* bilateral strokes affecting sensorimotor structures
* severe cognitive impairment
* substantially elevated tone/spasticity in wrist/hand (Modified Ashworth Scale \>3)
* severe contracture
* participation in outpatient or Botox therapy within 2 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No