Premotor Cortex: A New Target for Stroke Motor Rehabilitation

Stroke Clinical Trial

Official title:

Premotor Cortex: A New Target for Stroke Motor Rehabilitation Using Transcranial Magnetic Stimulation

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02565199
• Other study ID #: IRB00081901
• Status: Suspended
• Phase: N/A
• Start date: September 2015
• Est. completion date: February 2024

Study information

• Verified date: August 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: February 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• 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
• 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
• 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
• 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
• 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

Other:
• 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.

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in wrist acceleration	The subjects will be asked to perform 7 isometric wrist extensions before and after motor training. Wrist acceleration will be measured by a gyroscope taped to the dorsum of the subject's hand undergoing motor training. An increase in the maximum acceleration that persists at least an hour after training is indicative of motor learning. We will compare the effect of the rTMS protocols on the change in the wrist acceleration associated with motor learning (baseline to post 1 min, baseline to post 30 mins, baseline to post 60 mins).	Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
Primary	Change in stimulus response curve (SRC)	The stimulus response curve (SRC) is a set of motor evoked potentials (MEPs) collected in response to transcranial magnetic stimulation (TMS) pulses of increasing intensities. The SRC can characterize input-output parameters of the corticospinal tract and organization of the primary motor cortex. A change in the SRC parameters after training will reflect a change in the organization of the primary motor cortex associated with motor learning. We will compare the effect of the rTMS protocols on the change in the SRC parameters associated with motor learning (baseline to post 1 min, baseline to post 30 mins, baseline to post 60 mins).	Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
Primary	Change in short interval intracortical inhibition (SICI)	Short interval intracortical inhibition (SICI) is an inhibitory phenomenon in the motor cortex. To test for SICI, a sub-threshold conditioning stimulus (CS) will precede a supra-threshold test stimulus (TS) by 2 milliseconds (ms). The amplitude of a conditioned TS-evoked MEP will be expressed as a percent of the amplitude of an unconditioned TS-evoked MEP. A decrease in the percent MEP after training would indicate a increase in SICI. An increase in the percent MEP after training would indicate a decrease in SICI. We will compare the effect of the rTMS protocols on the change in SICI associated with motor learning (baseline to post 1 min, baseline to post 30 mins, baseline to post 60 mins).	Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
Secondary	Change in wrist force	The subjects will be asked to perform 7 isometric wrist extensions before and after motor training. A force transducer transducer will record the maximum force produced during the wrist extensions.	Baseline, post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
Secondary	Change in reaction time	Subjects will be asked to perform 7 auditory-cued ballistic wrist extensions before and after motor training. Electomyographic (EMG) activity recorded during the ballistic wrist extensions will be used to measure reaction time. Reaction time is the length of time between the auditory cue and the onset of the movement-related EMG burst of the extensor carpi ulnaris (ECU) muscle.	Baseline and post-motor training (1 minute, 30 minutes and 60 minutes after completion of motor training)
Secondary	Change in task accuracy	Task accuracy will be determined by the number of successful trials over the number of total trials. A trial will be considered successful when the subject moves a cursor from the home position into a target box by modulating the acceleration of their wrist. An increase in task accuracy after training will indicate motor learning.	Baseline and post-motor training (1 minute after completion of motor training)