Investigating Motor Cortex Processing for Pain Modulation

NCT01404039 | Terminated Phase 1 Results

• 1 other identifier: 2010-p-001256
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Motor Activity

Keywords

learning; pain perception

Outcome Measures

Primary Outcomes (1)

• Change in Motor Cortex Excitability MEP Amplitude

  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).

  after each intervention

Study Arms (13)

Motor Learning (ML) sighted

EXPERIMENTAL

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.

Behavioral: Motor Learning

Motor Learning (ML) blind

EXPERIMENTAL

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.

Behavioral: Motor Learning

Motor Learning (ML) control group

PLACEBO COMPARATOR

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.

Behavioral: Motor Learning

Somatosensory Learning (SL sighted)

EXPERIMENTAL

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).

Behavioral: Somatosensory Learning

Somatosensory Learning (SL blind)

EXPERIMENTAL

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).

Behavioral: Somatosensory Learning

Somatosensory Activation (S activation)

EXPERIMENTAL

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).

Behavioral: Somatosensory Learning

Somatosensory Learning (SL) control group

PLACEBO COMPARATOR

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).

Behavioral: Somatosensory Learning

Observational Task (OT) - real

EXPERIMENTAL

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.

Behavioral: Observational Task

Observational Task (OT) - control group

PLACEBO COMPARATOR

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.

Behavioral: Observational Task

Mental Imagery (MI) - real

EXPERIMENTAL

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.

Behavioral: Mental Imagery

Mental Imagery (MI) - control group

PLACEBO COMPARATOR

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.

Behavioral: Mental Imagery

transcranial direct current stimulation - tDCS real

EXPERIMENTAL

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.

Device: transcranial direct current stimulation

transcranial direct current stimulation - tDCS sham

PLACEBO COMPARATOR

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.

Device: transcranial direct current stimulation

Interventions

Motor Learning BEHAVIORAL

Subject will have to draw a set of shapes and words during 20 minutes.

Motor Learning (ML) blind; Motor Learning (ML) control group; Motor Learning (ML) sighted

Somatosensory Learning BEHAVIORAL

Subjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille.

Somatosensory Activation (S activation); Somatosensory Learning (SL blind); Somatosensory Learning (SL sighted); Somatosensory Learning (SL) control group

Observational Task BEHAVIORAL

Subjects will watch a 10 second video of a right-handed person performing movements of their left index finger. Subjects will be instructed to watch the video without any other specific instruction.

Observational Task (OT) - control group; Observational Task (OT) - real

Mental Imagery BEHAVIORAL

Subjects will be asked to perform mental imagery of motor practice - finger movements of the left hand for 10 minutes.

Mental Imagery (MI) - control group; Mental Imagery (MI) - real

transcranial direct current stimulation DEVICE

Subjects will undergo active and sham tDCS stimulation in a randomized and counterbalanced order. During both active and sham stimulation, we will use electrodes of 35cm\^2, intensity of 2mA for a duration of 20 minutes. The anode electrode will be placed over the right primary motor cortex (M1) and the cathode will be placed over the contralateral supraorbital area. For active stimulation, the current will be on for the duration of 20 minutes. For sham stimulation, the current will ramp up, and then down again for 30 seconds to simulate the sensation of active tDCS.

transcranial direct current stimulation - tDCS real; transcranial direct current stimulation - tDCS sham

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide informed consent to participate in the study
• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Felipe Fregni
• Organization: Spaulding Rehabilitation Hospital

felipe.fregni@ppcr.hms.harvard.edu

6179526156

Study Officials

• Felipe Fregni, MD, PhD, MPH

  Spaulding Rehabilitation Hospital (SRH)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There are 5 experiments: motor learning (3 groups, crossover), sensory learning (4 groups, parallel), observational task (2 groups, parallel), mental imagery (2 groups, parallel), and tDCS over the motor cortex (2 groups, crossover). Please note that the tDCS experiment has never been conducted.

Study Record Dates

• First Submitted: June 29, 2011
• First Posted: July 27, 2011
• Study Start: September 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 24, 2020
• Results First Posted: March 16, 2017

Record last verified: 2020-04

Locations

US (1)