Motor ActivityPhase 1NCT01404039
Investigating Motor Cortex Processing for Pain Modulation
A Phase 1 study testing Motor Learning, Somatosensory Learning and Observational Task in people with Motor Activity, run by Spaulding Rehabilitation Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Motor Activity
- What is being tested?
- Motor Learning, Somatosensory Learning and Observational Task
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Apr 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the 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.
- Conditions
- Motor Activity
- Being tested
- Motor Learning, Somatosensory Learning, Observational Task, Mental Imagery, transcranial direct current stimulation
- Keywords
- learning, pain perception
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor LearningBehavioural
Subject will have to draw a set of shapes and words during 20 minutes.
Somatosensory LearningBehavioural
Subjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille.
Observational TaskBehavioural
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 ImageryBehavioural
Subjects will be asked to perform mental imagery of motor practice - finger movements of the left hand for 10 minutes.
transcranial direct current stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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). Receives: 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). Receives: 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). Receives: 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). Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: after each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2011 (estimated)
- Study startSep 2010
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Study was halted due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Fregni, Spaulding Rehabilitation Hospital
- Investigators
- Felipe Fregni, MD, PhD, MPH, Principal investigator, Spaulding Rehabilitation Hospital (SRH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404039
- Sponsor's protocol ID
- 2010-p-001256
- Status last verified
- Apr 2020
- First submitted
- 29 Jun 2011
- Last updated
- 24 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Motor Cortex Processing for Pain Modulation
- ClinicalTrials.gov ID
- NCT01404039
- Acronym / sponsor ID
- 2010-p-001256
- Conditions
- Motor Activity
- Keywords
- learning, pain perception
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was halted due to lack of funding.
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Jul 2011 (estimated)
- Results
- Posted 16 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 13
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Motor Learning (ML) sighted | Experimental | Behavioral: Motor LearningIn 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. |
| Motor Learning (ML) blind | Experimental | Behavioral: Motor LearningIn 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) control group | Placebo comparator | Behavioral: Motor LearningIn 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 Learning (SL sighted) | Experimental | Behavioral: Somatosensory LearningIn 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). |
| Somatosensory Learning (SL blind) | Experimental | Behavioral: Somatosensory LearningIn 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). |
| Somatosensory Activation (S activation) | Experimental | Behavioral: Somatosensory LearningIn 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). |
| Somatosensory Learning (SL) control group | Placebo comparator | Behavioral: Somatosensory LearningIn 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) - real | Experimental | Behavioral: Observational TaskIn 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. |
| Observational Task (OT) - control group | Placebo comparator | Behavioral: Observational TaskIn 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 | Experimental | Behavioral: Mental ImageryIn 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 | Placebo comparator | Behavioral: Mental ImageryIn 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. |
| transcranial direct current stimulation - tDCS real | Experimental | Device: transcranial direct current stimulationtDCS 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. |
| transcranial direct current stimulation - tDCS sham | Placebo comparator | Device: transcranial direct current stimulationtDCS 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor LearningSubject will have to draw a set of shapes and words during 20 minutes. | Behavioural | Motor Learning (ML) blind, Motor Learning (ML) control group, Motor Learning (ML) sighted |
| Somatosensory LearningSubjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille. | Behavioural | Somatosensory Activation (S activation), Somatosensory Learning (SL blind), Somatosensory Learning (SL sighted), Somatosensory Learning (SL) control group |
| Observational TaskSubjects 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. | Behavioural | Observational Task (OT) - control group, Observational Task (OT) - real |
| Mental ImagerySubjects will be asked to perform mental imagery of motor practice - finger movements of the left hand for 10 minutes. | Behavioural | Mental Imagery (MI) - control group, Mental Imagery (MI) - real |
| transcranial direct current stimulationSubjects 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. | Device | transcranial direct current stimulation - tDCS real, transcranial direct current stimulation - tDCS sham |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felipe Fregni, MD, PhD, MPH principal investigator
Spaulding Rehabilitation Hospital (SRH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Motor Learning, Somatosensory Learning and Observational Task in people with Motor Activity, run by Spaulding Rehabilitation Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Motor Cortex Excitability MEP Amplitude (time frame: after each intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.