Investigating Motor Cortex Processing for Pain Modulation

Motor Activity Clinical Trial

Official title:

Investigating Motor Cortex Processing for Pain Modulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01404039
• Other study ID #: 2010-p-001256
• Status: Terminated
• Phase: Phase 1
• Start date: September 2010
• Est. completion date: April 2014

Study information

• Verified date: April 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 115
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Motor Activity

Intervention

Behavioral:
• Motor Learning
Subject will have to draw a set of shapes and words during 20 minutes.
• Somatosensory Learning
Subjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille.
• Observational Task
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.
• Mental Imagery
Subjects will be asked to perform mental imagery of motor practice - finger movements of the left hand for 10 minutes.

Device:
• transcranial direct current stimulation
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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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