Premotor Cortex: A New Target for Stroke Motor Rehabilitation

NCT ID: NCT02565199

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2024-02-29

Brief Summary

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.

Detailed 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Single motor training only

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.

Group Type: EXPERIMENTAL

Motor Training

Intervention Type: OTHER

During motor training, participants will quickly extend their hand at a pace of one extension every 5 seconds (0.2Hz) in response to an auditory cue.

Repetitive TMS during motor training

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.

Group Type: EXPERIMENTAL

rTMS over Premotor Cortex (Contralateral Hemisphere)

Intervention Type: DEVICE

• Location of rTMS: premotor cortex
• Frequency of rTMS: 0.1 Hz
• Time of rTMS: 50 milliseconds before the onset of movement-related EMG
• Device: MagStim Super Rapid 2 Transcranial Magnetic Stimulator

rTMS over Premotor Cortex (Ipsilateral Hemisphere)

Intervention Type: DEVICE

• Location of rTMS: premotor cortex
• Frequency of rTMS: 0.1 Hz
• Time of rTMS: 50 milliseconds before the onset of movement-related EMG
• Device: Super Rapid 2 Transcranial Magnetic Stimulator

rTMS (Control 1)

Intervention Type: DEVICE

• Location of rTMS: premotor cortex
• Frequency of rTMS: 0.1 Hz
• Time of rTMS: 400 milliseconds after the onset of movement-related EMG
• Device: Super Rapid 2 Transcranial Magnetic Stimulator

rTMS (Control 2)

Intervention Type: DEVICE

• Location of rTMS: somatosensory cortex
• Frequency of rTMS: 0.1 Hz
• Time of rTMS: 50 milliseconds before the onset of movement-related EMG
• Device: Super Rapid 2 Transcranial Magnetic Stimulator

rTMS (Control 3)

Intervention Type: DEVICE

• Location of rTMS: premotor cortex
• Frequency of rTMS: 0.1 Hz
• Time of rTMS: 50 milliseconds before the onset of movement-related EMG
• Device: Super Rapid 2 Transcranial Magnetic Stimulator with Sham Coil

Motor Training

Intervention Type: OTHER

During motor training, participants will quickly extend their hand at a pace of one extension every 5 seconds (0.2Hz) in response to an auditory cue.

Interventions

rTMS over Premotor Cortex (Contralateral Hemisphere)

• Location of rTMS: premotor cortex
• Frequency of rTMS: 0.1 Hz
• Time of rTMS: 50 milliseconds before the onset of movement-related EMG
• Device: MagStim Super Rapid 2 Transcranial Magnetic Stimulator

Intervention Type: DEVICE

rTMS over Premotor Cortex (Ipsilateral Hemisphere)

• Location of rTMS: premotor cortex
• Frequency of rTMS: 0.1 Hz
• Time of rTMS: 50 milliseconds before the onset of movement-related EMG
• Device: Super Rapid 2 Transcranial Magnetic Stimulator

Intervention Type: DEVICE

rTMS (Control 1)

• Location of rTMS: premotor cortex
• Frequency of rTMS: 0.1 Hz
• Time of rTMS: 400 milliseconds after the onset of movement-related EMG
• Device: Super Rapid 2 Transcranial Magnetic Stimulator

Intervention Type: DEVICE

rTMS (Control 2)

• Location of rTMS: somatosensory cortex
• Frequency of rTMS: 0.1 Hz
• Time of rTMS: 50 milliseconds before the onset of movement-related EMG
• Device: Super Rapid 2 Transcranial Magnetic Stimulator

Intervention Type: DEVICE

rTMS (Control 3)

• Location of rTMS: premotor cortex
• Frequency of rTMS: 0.1 Hz
• Time of rTMS: 50 milliseconds before the onset of movement-related EMG
• Device: Super Rapid 2 Transcranial Magnetic Stimulator with Sham Coil

Intervention Type: DEVICE

Motor Training

During motor training, participants will quickly extend their hand at a pace of one extension every 5 seconds (0.2Hz) in response to an auditory cue.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Cathrin Buetefisch

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emory University

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

IRB00081901

Identifier Type: -

Identifier Source: org_study_id