Premotor Cortex: A New Target for Stroke Motor Rehabilitation

Emory University

Status: Suspended

Conditions: Stroke

Treatments: Other: Motor Training; Device: rTMS (Control 1); Device: rTMS over Premotor Cortex (Ipsilateral Hemisphere); Device: rTMS (Control 2); Device: rTMS (Control 3); Device: rTMS over Premotor Cortex (Contralateral Hemisphere)

Study type: Interventional

Funder types: Other

Identifiers

NCT02565199

IRB00081901

Details and patient eligibility

About

The goal of the study is to determine the effect of repetitive transcranial magnetic stimulation (rTMS) over the premotor cortex on training-related improvements in motor performance and associated neural plasticity.

Full description

Motor training is an important part of recovery after stroke. During motor training, stroke patients practice performing a movement and become better at performing the trained movement over time. Repetitive transcranial magnetic stimulation (rTMS), which uses magnetism to excite neurons near the surface of the brain, may further improve performance. Healthy adults made larger training-related improvements in their motor performance when they received rTMS over the primary motor cortex during motor training. There is evidence that the premotor cortex may be a more effective target than the primary motor cortex for rTMS for some stroke survivors. In the current study, the investigator will determine the effect of rTMS over the premotor cortex on training-related improvements in motor performance in healthy adults.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Motor training only (pilot participants):

• Have the ability to give informed, written consent
• Be aged 18-80 years old
• Be right-handed using the Edinburgh handedness inventory
• Have intact cognitive abilities (score higher than 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS))
• No current depression (score less than 7 on the Hamilton Depression Rating Scale (HDRS))
• No neurological disease
• No contradictions to Transcranial Magnetic Stimulation (TMS)
• TMS over the extensor carpi ulnaris (ECU) hotspot must evoke a motor evoked potential (MEP) in the ECU muscle
• MEP amplitude must increase by at least 20% as the TMS intensity increases
• The subjects must be comfortable when receiving TMS of all strengths.

Remaining study participants:

• Have the ability to give informed, written consent
• Be aged 55-80 years old
• Be right-handed using the Edinburgh handedness inventory
• Have intact cognitive abilities (score higher than 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS))
• No current depression (score less than a 7 on the Hamilton Depression Rating Scale (HDRS))
• No neurological disease
• No contradictions to Transcranial Magnetic Stimulation (TMS)
• TMS over the extensor carpi ulnaris (ECU) hotspot must be able to evoke a motor evoked potential (MEP) in the ECU muscle
• MEP amplitude must increase by at least 20% as the TMS intensity increases
• The subjects must be comfortable when receiving TMS of all strengths.

Exclusion criteria

• Impaired cognitive abilities (score lesser than 75th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS))
• Current depression (score more than 7 on the Hamilton Depression Rating Scale (HDRS))
• Neurological disease
• Has a contradiction to TMS
• MEP cannot be evoked with TMS in the ECU muscle
• Inability to tolerate one or more TMS strengths

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Single motor training only

Experimental group

Description:

For a pilot experiment, healthy, right-handed subjects will complete one testing session. During the testing session, subjects will complete motor training. The results of this experiment will determine the motor training protocol used in the main experiment.

Treatment:

Other: Motor Training

Repetitive TMS during motor training

Experimental group

Description:

Healthy, right-handed subjects will complete five testing sessions. During each testing session, subjects will complete motor training while receiving one of five repetitive transcranial magnetic stimulation (rTMS) protocols. Subjects will receive a different rTMS protocol at each testing session. By the end of the study, each subject will have received all rTMS protocols.

Treatment:

Device: rTMS (Control 3)

Other: Motor Training

Device: rTMS over Premotor Cortex (Contralateral Hemisphere)

Device: rTMS (Control 2)

Device: rTMS (Control 1)

Device: rTMS over Premotor Cortex (Ipsilateral Hemisphere)