Investigating Motor Cortex Processing for Pain Modulation

Phase 1

Terminated

Conditions: Motor Activity

Interventions: Behavioral: Motor Learning
Behavioral: Somatosensory Learning
Behavioral: Observational Task
Behavioral: Mental Imagery
Device: transcranial direct current stimulation

Registration Number: NCT01404039

Lead Sponsor: Spaulding Rehabilitation Hospital

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.

Exp5: tDCS over the motor cortex (2 groups, crossover) - active and sham tDCS. Note that this study has never been completed.

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 115

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Motor Learning (ML) blind	Motor Learning	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.
Motor Learning (ML) sighted	Motor Learning	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.
Somatosensory Learning (SL) control group	Somatosensory Learning	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).
Observational Task (OT) - control group	Observational Task	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.
Mental Imagery (MI) - real	Mental Imagery	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.
Mental Imagery (MI) - control group	Mental Imagery	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.
Motor Learning (ML) control group	Motor Learning	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.
Somatosensory Activation (S activation)	Somatosensory Learning	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).
Observational Task (OT) - real	Observational Task	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.
transcranial direct current stimulation - tDCS sham	transcranial direct current stimulation	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.
Somatosensory Learning (SL sighted)	Somatosensory Learning	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).
transcranial direct current stimulation - tDCS real	transcranial direct current stimulation	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.
Somatosensory Learning (SL blind)	Somatosensory Learning	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).

Primary Outcome Measures

Name	Time	Method
Change in Motor Cortex Excitability MEP Amplitude	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).