Investigating Motor Cortex Processing for Pain Modulation
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Enrollment
- 115
- Locations
- 1
- Primary Endpoint
- Change in Motor Cortex Excitability MEP Amplitude
Study Overview
Brief Summary
The purpose of this study is to investigate the effects of different types of interventions (motor learning, somatosensory learning, observation task, mental imagery and tDCS) on the perception of pain and motor cortex excitability in healthy male subjects. This is an exploratory study of healthy subjects only.
Detailed Description
There are 5 experiments:
Exp1: motor learning (3 groups, crossover) - motor leaning with and without visual feedback and a control group.
Exp2: sensory learning (4 groups, parallel) - sensory learning with and without feedback, an simple activation task and a control group.
Exp3: observational task (2 groups, parallel) - an motor observational task and a control group.
Exp4: mental imagery (2 groups, parallel) - a motor mental imagery and a control group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Provide informed consent to participate in the study
- •18 to 64 years old
- •No presence of rheumatologic disease as self reported
- •No clinically significant or unstable medical or psychiatric disorder as self reported
- •No history of alcohol or substance abuse within the last 6 months as self reported
- •No neuropsychiatric co-morbidity as self reported
- •No Contraindications to single pulse TMS (TMS will be used to measure cortical excitability)
- •history of seizures
- •unexplained loss of consciousness
- •metal in the head
- •frequent or severe headaches or neck pain
- •implanted brain medical devices
- •No Contraindications to tDCS
- •metal in the head
- •implanted brain medical devices
Exclusion Criteria
- Not provided
Arms & Interventions
Motor Learning (ML) sighted
In this arm, subject will perform motor Learning with visual feedback - ML sighted.
There will be an anticipated total of 15 subjects in this experimental arm. This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
Intervention: Motor Learning (Behavioral)
Motor Learning (ML) blind
In this arm, subject will perform motor Learning without visual feedback - ML blind.
There will be an anticipated total of 15 subjects in this experimental arm. This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
Intervention: Motor Learning (Behavioral)
Motor Learning (ML) control group
In this arm, subject will perform simple hand movements - control group. There will be an anticipated total of 15 subjects in this experimental arm. This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
Intervention: Motor Learning (Behavioral)
Somatosensory Learning (SL sighted)
In this arm, subject will perform sensory Learning with visual feedback - SL sighted.
There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control).
Intervention: Somatosensory Learning (Behavioral)
Somatosensory Learning (SL blind)
In this arm, subject will perform sensory Learning without visual feedback - SL blind.
There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control).
Intervention: Somatosensory Learning (Behavioral)
Somatosensory Activation (S activation)
In this arm, subject will receive simple sensory stimulation over their left index finger - Sactivation.
There will be an anticipated total of 10 subjects in this experimental arm.This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control).
Intervention: Somatosensory Learning (Behavioral)
Somatosensory Learning (SL) control group
In this arm,the subjects will not receive any somatosensory input (SL control group).
There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control).
Intervention: Somatosensory Learning (Behavioral)
Observational Task (OT) - real
In this arm, the subjects will perform an observational task - observation of hand movements. This experimental arm will be conducted in a parallel design. There will be 15 subjects per intervention.
Intervention: Observational Task (Behavioral)
Observational Task (OT) - control group
In this arm, the subjects will perform a controlled observational task - observation of geometric shapes. This experimental arm will be conducted in a parallel design. There will be 15 subjects per intervention.
Intervention: Observational Task (Behavioral)
Mental Imagery (MI) - real
In this arm, the subjects will perform mental imagery - mental imagery of finger movements. This experimental arm will be conducted in a parallel design. There will be 15 subjects per intervention.
Intervention: Mental Imagery (Behavioral)
Mental Imagery (MI) - control group
In this arm, the subjects will perform a controlled task - simple mental calculation. This experimental arm will be conducted in a parallel design. There will be 15 subjects per intervention.
Intervention: Mental Imagery (Behavioral)
transcranial direct current stimulation - tDCS real
tDCS will be applied over the motor cortex for 20minutes at an intensity of 2mA. 15 subjects will be enrolled. The subjects will undergo two interventions, real and sham in a counterbalanced randomized order. There will be at least 3 days between each experimental session.
Intervention: transcranial direct current stimulation (Device)
transcranial direct current stimulation - tDCS sham
tDCS will be applied over the motor cortex for 20minutes at an intensity of 2mA. The stimulation will be stopped after 30seconds.
15 subjects will be enrolled. The subjects will undergo two interventions, real and sham in a counterbalanced randomized order. There will be at least 3 days between each experimental session.
Intervention: transcranial direct current stimulation (Device)
Outcomes
Primary Outcomes
Change in Motor Cortex Excitability MEP Amplitude
Time Frame: after each intervention
We aim to assess the effects of the intervention (ML, SL, OT and MI) on motor cortex excitability as measured by the change in motor evoked potential (using transcranial magnetic stimulation) before and after the given intervention. * For ML: MEP will be measured before and after each ML sessions in the same subject (crossover design - ML sighted/MLblind/ML control). * For SL: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group). * For OT: MEP will be measured before and after the treatment session in the each groups (parallel - 1 session per group). * For MI: MEP will be measured before and after the treatment session in the each groups (parallel design - 1 session per group).
Secondary Outcomes
No secondary outcomes reported
Investigators
Felipe Fregni
Principal Investigator
Spaulding Rehabilitation Hospital