Investigating Motor Cortex Processing for Pain Modulation

Mass General Brigham

Status and phase: Terminated; Phase 1

Conditions: Motor Activity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01404039

2010-p-001256

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Provide informed consent to participate in the study

2. 18 to 64 years old

3. No presence of rheumatologic disease as self reported

4. No clinically significant or unstable medical or psychiatric disorder as self reported

5. No history of alcohol or substance abuse within the last 6 months as self reported

6. No neuropsychiatric co-morbidity as self reported

7. 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

8. No Contraindications to tDCS

   • metal in the head
   • implanted brain medical devices

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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115 participants in 13 patient groups, including a placebo group

Motor Learning (ML) sighted

Experimental group

Description:

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.

Treatment:

Behavioral: Motor Learning

Motor Learning (ML) blind

Experimental group

Description:

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.

Treatment:

Behavioral: Motor Learning

Motor Learning (ML) control group

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Motor Learning

Somatosensory Learning (SL sighted)

Experimental group

Description:

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).

Treatment:

Behavioral: Somatosensory Learning

Somatosensory Learning (SL blind)

Experimental group

Description:

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).

Treatment:

Behavioral: Somatosensory Learning

Somatosensory Activation (S activation)

Experimental group

Description:

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).

Treatment:

Behavioral: Somatosensory Learning

Somatosensory Learning (SL) control group

Placebo Comparator group

Description:

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).

Treatment:

Behavioral: Somatosensory Learning

Observational Task (OT) - real

Experimental group

Description:

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.

Treatment:

Behavioral: Observational Task

Observational Task (OT) - control group

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Observational Task

Mental Imagery (MI) - real

Experimental group

Description:

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.

Treatment:

Behavioral: Mental Imagery

Mental Imagery (MI) - control group

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Mental Imagery

transcranial direct current stimulation - tDCS real

Experimental group

Description:

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.

Treatment:

Device: transcranial direct current stimulation

transcranial direct current stimulation - tDCS sham

Placebo Comparator group

Description:

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.

Treatment:

Device: transcranial direct current stimulation