A Novel Approach for Brain Stimulation in Severe Stroke

NeuroTherapia, Inc.

Status and phase: Completed; Early Phase 1

Conditions: Stroke

Treatments: Device: New Repetitive Magnetic Stimulation (rTMS) Approach; Device: Conventional Repetitive Magnetic Stimulation (rTMS) Approach

Study type: Interventional

Funder types: Other

Identifiers

NCT03868410

18-861

Details and patient eligibility

About

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

Full description

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).

Enrollment: 16 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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
• exclusion criteria for TMS and MRI (metal implant in head, H/O seizures, alcohol or substance abuse, intake of medications contraindicated with TMS, cardiac pacemaker or programmable implant).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 2 patient groups

Contralesional dorsal premotor cortex (cPMD) rTMS + Training

Active Comparator group

Description:

New Approach

Treatment:

Device: New Repetitive Magnetic Stimulation (rTMS) Approach

Ipsilesional Primary Motor Cortex (iM1) rTMS + Training

Active Comparator group

Description:

Conventional Approach

Treatment:

Device: Conventional Repetitive Magnetic Stimulation (rTMS) Approach