Parkinson's DiseaseNCT01019343
Physiological Investigations of Movement Disorders
A study testing Transcranial Direct Current Stimulation (tDCS), Eye-tracking Device and Pulsed vibrator in people with Parkinson's Disease and Tourette's Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Previous studies have given researchers information on how the brain controls movement, how people learn to make fine, skilled movements, and why some people have movement disorders. However, further research is needed to learn more about the causes of most movement disorders, such as Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Tourette's Syndrome, Tic Disorders
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS), Eye-tracking Device and Pulsed vibrator
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,273 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2009to 9 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will either have a well-defined diagnosis or be a diagnostic dilemma, depending upon the sub-study
- Age 18 or older
- Able to give informed consent
- Agree to not drink caffeine or alcohol for 48 hours before certain study sessions because both agents can modify brain activity and may confound outcome measures.
- Age 18 or older.
- Able to give informed consent.
- Agree to not drink caffeine or alcohol for 48 hours before certain study sessions because both agents may modify the activity of the brain during the study.
Who cannot join
- Have used illegal drugs within the past 6 months
- Have more than 7 alcoholic drinks a week in the case of a woman or 14 alcoholic drinks a week in the case of a man.
- Have had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures.
- Have a psychotic disorder, Bipolar Disorder or a current depressive episode.
- Have another neurologic disorder than a movement disorder
- Have had a head injury where there was a loss of consciousness for more than a few seconds.
Show all 24Show fewer
- Have abnormal findings on a neurological examination that we will perform
- Have used illegal drugs within the past 6 months
- Have more than 7 alcoholic drinks a week in the case of a woman or 14 alcoholic drinks a week in the case of a man
- Have had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures.
- Have major depression or any major mental disorders (axis I disorders)
- Have had a head injury where there was a loss of consciousness for more than a few seconds.
- ADDITIONAL EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS AND HEALTHY VOLUNTEERS SPECIFICALLY FOR fMRI:
- We will follow the NMR Center guidelines for MR safety.
- Some of the exclusions are:
- Have non-MRI compatible metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or metal fragments in the eye as these make having an MRI unsafe.
- Unable to lie flat on the back for the expected length of the experiment up to 3 hours
- Have uncontrolled movements of the head
- Have an abnormality on the brain imaging or neurologic examination not related to the diagnosis
- Uncomfortable being in a small space for the expected length of the experiment up to 3 hours
- Pregnancy
- ADDITIONAL EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS AND HEALTHY VOLUNTEERS SPECIFICALLY FOR TMS:
- Have metal in the eye or skull area, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, metal fragments in the eye, as these make TMS unsafe. Having a cardiac pacemaker, intracardiac lines, implanted pumps or stimulators are also exclusion criteria.
- Have hearing loss.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
- Previous studies have given researchers information on how the brain controls movement, how people learn to make fine, skilled movements, and why some people have movement disorders. However, further research is needed to learn more about the causes of most movement disorders, such as Parkinson's disease.
- By using small, specialized studies to evaluate people with movement disorders and compare them with healthy volunteers, researchers hope to learn more about the changes in the brain and possible causes of movement disorders.
Read more
Objectives:
- To better understand how the brain controls movement.
- To learn more about movement disorders.
- To train movement disorder specialists.
Eligibility:
- Individuals 18 years of age or older who have had a movement disorder diagnosed by a neurologist and are able to participate based on the specific requirements of the small study.
- Healthy volunteers 18 years of age or older.
Design:
- Participants will have a screening visit with medical history, physical examination, and questionnaire to determine eligibility. Eligible participants will give consent to participate in up to seven additional outpatient visits for study procedures. The number of sessions and the procedures needed for participation depend on specific symptoms.
- Participants must avoid drinking alcohol or caffeinated drinks (sodas, coffee, and tea) for at least 2 days (48 hours) before each session.
- Potential studies may include magnetic resonance imaging (MRI) scans, functional MRI scans, electroencephalography, magnetoencephalography, transcranial magnetic stimulation, nerve and sensory stimulation, or movement and mental tasks during any of the above procedures.
- This study does not provide treatment for movement disorders. Participants will not have to stop any treatment in order to participate.
Read the detailed description
Objectives
The purpose of this protocol is to improve understanding of the pathophysiology of movement disorders by performing small behavioral, electrophysiological and neuroimaging sub-studies. This will allow identifying dysfunction of the central nervous system that causes behavioral abnormalities seen in movement disorder patients. This will also help to determine potential diagnostic or therapeutic targets. Some sub-studies will require healthy volunteers. We will conduct:
- Pilot Sub-study (previously labeled as Small Pilot Sub-studies) Pilot sub-studies are exploratory in nature, in order to develop enough information to generate a hypothesis. The criterion for transition to a new full protocol will be a sufficient amount of information to generate a power analysis. There are no enrollment limitations for pilot sub-studies.Small substudies to pilot investigations for larger studies,
- Hypothesis-Testing Sub-study (previously labeled small number sSub-studies) is defined as a study with a specific hypothesis to be thattested that can be completed with a few subjects healthy volunteers or patients, , Hypothesis-testing sub-studies will undergo statistical and PIRC review after 6 subjects (if there is one group) or after 12 (six per arm) if two groups are studied before additional subjects are recruited. Together, the P.I. and PIRC will decide whether to continue the hypothesis sub-study with more subjects or if a new protocol is necessary. A memo requesting a review of hypothesis-testing sub-studies for possible additional enrollment will be sent to PIRC and the statistical reviewer. If the action to request accrual increase proceeds beyond PIRC to the IRB, then it needs to be submitted in the form of an amendment for prospective review/approval.
- Individual patient investigations that may increase knowledge of a disease process or be helpful in patient diagnosis,
- Training for investigators who do not have prior experience using electrophysiological and neuroimaging techniques,
- Technical development of new experimental paradigms.
This protocol includes only non-invasive techniques with minimal risk (MRI, EEG, MEG, peripheral nerve stimulation, TMS).
Study population
We intend to study 1200 healthy volunteers and 1000 patients with diagnoses of movement disorders.
Design
We will design small projects as ideas arise in our patient population that are pertinent to the theme of movement disorder pathophysiology. We will investigate patients with movement disorders or healthy volunteers in the resting state or while they perform simple motor or sensory tasks. If a small study leads to results of interest and if a larger population is necessary to reach statistical significance, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot or exploratory sub-studies performed in the present protocol.
Outcome measures
MRI: we will analyze measures such as the amplitude of the BOLD signal (fMRI); tractography between seed and target regions of interest (using DTI); morphometry of brain regions (using VBM); and different neurotransmitter levels in brain regions of interest (using MRS).
EEG and MEG: we will quantify measures such as event- or task-related potentials, synchronization/desynchronization, and coherence between sensors or sources located close to the brain areas of interest.
TMS: we will analyze measures such as MEP amplitude and central conduction time.
Behavioral measures: we will quantify measures such as reaction times to initiate movements, EMG patterns, movement kinematics (position, velocity, acceleration, curvature).
We may measure autonomic data during the course of the experiment (such as blood pressure, skin conductance, and respiratory rate) which would correlate to the outcome measures.
- Being tested
- Transcranial Direct Current Stimulation (tDCS), Eye-tracking Device, Pulsed vibrator, Gait Trainer Treadmill (GTT), Standard psychiatric scales SCID-I, YBOCS and SCI-OBS-lifetime and cognitive scales MMSE and MOCA
- Keywords
- Magnetic Resonance Imaging (MRI), Magnetoencephalogram, Electroencephalogram (EEG), Transcranial Magnetic Stimulation (TMS), Motor Deficit
- Medical subject headings
- Parkinson Disease, Tourette Syndrome, Tic Disorders, Dystonia, Movement Disorders, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Procedure or surgery
Transcranial direct current stimulation involves the application of weak direct currents, delivered between two surface electrodes, placed over the scalp.
Eye-tracking DeviceDevice
The purpose of this device is to assess eye movement. Participants may sit down in front of a computer screen or a real-world environment, stand on a treadmill, or lie down in an MRI scanner. Small infrared cameras attached to the cap or glasses will be positioned in front of their eyes. Eye tracking might be performed alone, or in conjunction with EEG, EMG, fMRI or treadmill. The eye- tracking device is FDA approved and commercially available.
Pulsed vibratorDevice
This device would be used in experiments to see if gait can be improved and, if so, what parameters of stimulation are optimal.
Gait Trainer Treadmill (GTT)Other
The Gait Trainer is a specialized rehabilitation treadmill, which operates in both the forward and backwards mode allowing subjects to both train and undergo performance tasks in a relatively safe and expedient manner. The GTT is equipped with a mounted deck with built in sensors which monitors and records subjects gait speed, step length, right to left time distribution, and symmetry in real time in both forward and reverse modes.
Standard psychiatric scales SCID-I, YBOCS and SCI-OBS-lifetime and cognitive scales MMSE and MOCAOther
Scales of motor function, cognitive function and psychiatric function are valuable supplements to clinical assessments of patients, giving quantitative information concerning these different aspects of brain function. Selected scales would be used only when potentially useful in a sub-study where such quantitative information would be correlated with a physiological or imaging result.
iMobilityDevice
This test uses the iMobility system. iMobility Device is a small device designed to measure movement through sensors (test monitors) worn by a patient via Velcro straps around an ankle or wrist or worn as a pendant around the neck to lie over the sternum. The device is a nonsignificant risk device.The iMobility Device has been used before, in the same format with a similar paradigm, in previous NIH studies.
QMATDevice
The purpose of this study is to assess the ability of the QMAT (quantitative motor assessment tool) to assess slowness of movement associated with Parkinson Disease. The QMAT device is FDA approved and has been used before, in the same format with a similar paradigm, in previous NIH studies.
Treadmill TestDiagnostic test
Subjects will be fitted in a weight support harness for safety. Sensors will be placed on the subject s shoes and harness. The sensors (VICON system) will be used to record their stride length, position and velocity as they walk on a treadmill. This system is a motion-tracking system that is designed to measure various aspects of a person s gait.
Arm Intellistretch DeviceDevice
The purpose of the Arm Intellistretch device is to objectively quantify wrist tone. It is used for rehabilitation applications in hospitals and office settings. Currently, rigidity is evaluated clinically using a subjective scale, zero to four and is part of the UPDRS. The Arm Intellistretch device is manufactured by Rehabtek, Inc., is FDA approved, and has been determined to be a non-significant risk device by the CNS IRB.
Transcranial Sonography (TCS)Procedure or surgery
Transcranial sonography will be conducted by a physician in the Clinical Center using the Acuson Antares ultrasound machine. This techniques uses ultrasound signals to image the brain. It entails having the subject sit in a chair or lay in a bed while the sonographer places a lubricated 2-inch ultrasound probe over the skin of the temporal area just above the patient s ear. Ultrasound images are then recorded. The procedure is not invasive and will last about 45 minutes.
Behavioral tasksOther
To assess the changes in cerebral physiology in the brain, subjects will be presented sensory stimuli (e.g., primary visual stimulation with flashing lights or checkerboard, auditory with tone or speech, or olfactory stimuli), or will be asked to perform non-exercise motor tasks (e.g., tapping of fingers, squeezing ball, moving joystick), to perform cognitive tasks such as a working memory task (e.g., n-back with or without catch rules, word finding), or to just rest or sleep.
TMS single/paired pulseProcedure or surgery
For MEP acquisition during TMS, electrodes will be placed over the belly and the tendon of the distal muscles of the hand or foot and/or proximal muscles (see sub-section EMG 7.1.3.1 for the details of the procedure).
MEGProcedure or surgery
MEG recordings will be performed together with experienced personnel in the NIMH MEG lab in the NMR center in Building 10. For these recording sessions, subjects will sit in a chair or lay down with a helmet placed over the head. The helmet used for MEG does not require the application of conductive gel. Scan times vary from 20 minutes to 2 hours.
EEGProcedure or surgery
EEGs will be recorded by, or together with, experienced personnel in the HMCS EEG lab in Building 10, or in the NMR center.
MRI techniquesProcedure or surgery
MRI sub-studies will be conducted on 3.0 T or 7T units in the NMR Research Center. All volunteers will comply with the yearly requirement of a standard clinical diagnostic MRI scan of the head performed at 3.0T, to be submitted to the Diagnostic Radiology Department of the Clinical Center for interpretation. If the subject does not have a clinical scan performed within 12 month of the exam, a standard clinical MRI will be performed and reviewed before the research MR. The standard examination takes approximately 15 minutes to complete; after that, the research MR scans will be performed. Standard clinical MRI of the head will be repeated on an annual basis and read by the Diagnostic Radiology Department of the Clinical Center.
Peripheral Nerve StimulationProcedure or surgery
Constant-current, 0.1 to 0.5 ms square-wave single pulses of electrical stimulation will be delivered through standard bar electrodes to nerves of the upper limb or of the lower limb. To study somatosensory evoked potentials, for example, the stimulus intensity will be set at just above the motor threshold for evoking a slight limb movement. Location of the electrical stimulation will depend on the specific objective of the sub-study. Peripheral nerve stimulation might be delivered during other types of experiments as well.
EMGProcedure or surgery
EMG measures the electrical activity of muscles. For our research purposes, only surface EMG will be used to measure the effects of central and peripheral nervous system stimulation. For surface EMG, electrodes will be coated with a conductive gel and taped to the skin. For motor evoked potential (MEP) acquisition during TMS, electrodes will be placed over the belly and the tendon of the distal muscles of the hand or foot and/or proximal muscles.
Trancutaneous spinal direct current stimulation (tsDCS)Procedure or surgery
Direct current (DC) stimulation is a non invasive tool used to promote plasticity of the central nervous system. Recently, DC stimulation has been applied to the human spinal cord, and known as transcutaneous spinal direct current stimulation (tsDCS).
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Placebo comparator | Healthy Volunteers Receives: Procedure: Transcranial Direct Current Stimulation (tDCS); Device: Eye-tracking Device; Device: Pulsed vibrator; Other: Gait Trainer Treadmill (GTT); Other: Standard psychiatric scales SCID-I, YBOCS and SCI-OBS-lifetime and cognitive scales MMSE and MOCA; Device: iMobility; Device: QMAT; Diagnostic Test: Treadmill Test; Device: Arm Intellistretch Device; Procedure: Transcranial Sonography (TCS); Other: Behavioral tasks; Procedure: TMS single/paired pulse; Procedure: MEG; Procedure: EEG; Procedure: MRI techniques; Procedure: Peripheral Nerve Stimulation; Procedure: EMG; Procedure: Trancutaneous spinal direct current stimulation (tsDCS) |
| Movement Disorder | Active comparator | Subjects diagnosed with movement disorder Receives: Procedure: Transcranial Direct Current Stimulation (tDCS); Device: Eye-tracking Device; Device: Pulsed vibrator; Other: Gait Trainer Treadmill (GTT); Other: Standard psychiatric scales SCID-I, YBOCS and SCI-OBS-lifetime and cognitive scales MMSE and MOCA; Device: iMobility; Device: QMAT; Diagnostic Test: Treadmill Test; Device: Arm Intellistretch Device; Procedure: Transcranial Sonography (TCS); Other: Behavioral tasks; Procedure: TMS single/paired pulse; Procedure: MEG; Procedure: EEG; Procedure: MRI techniques; Procedure: Peripheral Nerve Stimulation; Procedure: EMG; Procedure: Trancutaneous spinal direct current stimulation (tsDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI
analyze measures such as the amplitude of the BOLD signal (fMRI); tractography between seed and target regions of interest (using DTI); morphometry of brain regions (using VBM); and different neurotransmitter levels in brain regions of interest (using MRS).
Measured: throughout
EEG and MEG
quantify measures such as event- or task-related potentials, synchronization/desynchronization, and coherence between sensors or sources located close to the brain areas of interest.
Measured: throughout
TMS
analyze measures such as MEP amplitude and central conduction time.
Measured: throughout
Behavioral measures
quantify measures such as reaction times to initiate movements, EMG patterns, movement kinematics (position, velocity, acceleration, curvature), eye movement.
Measured: throughout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study start8 Dec 2009
- Primary completion17 Aug 2016
- Study completion9 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,273 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Avindra Nath, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019343
- Sponsor's protocol ID
- 100009
- Other IDs
- 10-N-0009
- Status last verified
- 16 Sep 2026
- First submitted
- 24 Nov 2009
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Investigations of Movement Disorders
- ClinicalTrials.gov ID
- NCT01019343
- Acronym / sponsor ID
- 100009
- Keywords
- Magnetic Resonance Imaging (MRI), Magnetoencephalogram, Electroencephalogram (EEG), Transcranial Magnetic Stimulation (TMS), Motor Deficit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,273 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 8 Dec 2009 (actual)
- Primary completion
- 17 Aug 2016 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 25 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Previous studies have given researchers information on how the brain controls movement, how people learn to make fine, skilled movements, and why some people have movement disorders. However, further research is needed to learn more about the causes of most movement disorders, such as Parkinson's disease.
- By using small, specialized studies to evaluate people with movement disorders and compare them with healthy volunteers, researchers hope to learn more about the changes in the brain and possible causes of movement disorders.
Objectives:
- To better understand how the brain controls movement.
- To learn more about movement disorders.
- To train movement disorder specialists.
Eligibility:
- Individuals 18 years of age or older who have had a movement disorder diagnosed by a neurologist and are able to participate based on the specific requirements of the small study.
- Healthy volunteers 18 years of age or older.
Design:
- Participants will have a screening visit with medical history, physical examination, and questionnaire to determine eligibility. Eligible participants will give consent to participate in up to seven additional outpatient visits for study procedures. The number of sessions and the procedures needed for participation depend on specific symptoms.
- Participants must avoid drinking alcohol or caffeinated drinks (sodas, coffee, and tea) for at least 2 days (48 hours) before each session.
- Potential studies may include magnetic resonance imaging (MRI) scans, functional MRI scans, electroencephalography, magnetoencephalography, transcranial magnetic stimulation, nerve and sensory stimulation, or movement and mental tasks during any of the above procedures.
- This study does not provide treatment for movement disorders. Participants will not have to stop any treatment in order to participate.
Detailed description
Objectives
The purpose of this protocol is to improve understanding of the pathophysiology of movement disorders by performing small behavioral, electrophysiological and neuroimaging sub-studies. This will allow identifying dysfunction of the central nervous system that causes behavioral abnormalities seen in movement disorder patients. This will also help to determine potential diagnostic or therapeutic targets. Some sub-studies will require healthy volunteers. We will conduct:
- Pilot Sub-study (previously labeled as Small Pilot Sub-studies) Pilot sub-studies are exploratory in nature, in order to develop enough information to generate a hypothesis. The criterion for transition to a new full protocol will be a sufficient amount of information to generate a power analysis. There are no enrollment limitations for pilot sub-studies.Small substudies to pilot investigations for larger studies,
- Hypothesis-Testing Sub-study (previously labeled small number sSub-studies) is defined as a study with a specific hypothesis to be thattested that can be completed with a few subjects healthy volunteers or patients, , Hypothesis-testing sub-studies will undergo statistical and PIRC review after 6 subjects (if there is one group) or after 12 (six per arm) if two groups are studied before additional subjects are recruited. Together, the P.I. and PIRC will decide whether to continue the hypothesis sub-study with more subjects or if a new protocol is necessary. A memo requesting a review of hypothesis-testing sub-studies for possible additional enrollment will be sent to PIRC and the statistical reviewer. If the action to request accrual increase proceeds beyond PIRC to the IRB, then it needs to be submitted in the form of an amendment for prospective review/approval.
- Individual patient investigations that may increase knowledge of a disease process or be helpful in patient diagnosis,
- Training for investigators who do not have prior experience using electrophysiological and neuroimaging techniques,
- Technical development of new experimental paradigms.
This protocol includes only non-invasive techniques with minimal risk (MRI, EEG, MEG, peripheral nerve stimulation, TMS).
Study population
We intend to study 1200 healthy volunteers and 1000 patients with diagnoses of movement disorders.
Design
We will design small projects as ideas arise in our patient population that are pertinent to the theme of movement disorder pathophysiology. We will investigate patients with movement disorders or healthy volunteers in the resting state or while they perform simple motor or sensory tasks. If a small study leads to results of interest and if a larger population is necessary to reach statistical significance, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot or exploratory sub-studies performed in the present protocol.
Outcome measures
MRI: we will analyze measures such as the amplitude of the BOLD signal (fMRI); tractography between seed and target regions of interest (using DTI); morphometry of brain regions (using VBM); and different neurotransmitter levels in brain regions of interest (using MRS).
EEG and MEG: we will quantify measures such as event- or task-related potentials, synchronization/desynchronization, and coherence between sensors or sources located close to the brain areas of interest.
TMS: we will analyze measures such as MEP amplitude and central conduction time.
Behavioral measures: we will quantify measures such as reaction times to initiate movements, EMG patterns, movement kinematics (position, velocity, acceleration, curvature).
We may measure autonomic data during the course of the experiment (such as blood pressure, skin conductance, and respiratory rate) which would correlate to the outcome measures.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Placebo comparator | Procedure: Transcranial Direct Current Stimulation (tDCS), Device: Eye-tracking Device, Device: Pulsed vibrator, Other: Gait Trainer Treadmill (GTT), Other: Standard psychiatric scales SCID-I, YBOCS and SCI-OBS-lifetime and cognitive scales MMSE and MOCA, Device: iMobility, Device: QMAT, Diagnostic Test: Treadmill Test, Device: Arm Intellistretch Device, Procedure: Transcranial Sonography (TCS), Other: Behavioral tasks, Procedure: TMS single/paired pulse, Procedure: MEG, Procedure: EEG, Procedure: MRI techniques, Procedure: Peripheral Nerve Stimulation, Procedure: EMG, Procedure: Trancutaneous spinal direct current stimulation (tsDCS)Healthy Volunteers |
| Movement Disorder | Active comparator | Procedure: Transcranial Direct Current Stimulation (tDCS), Device: Eye-tracking Device, Device: Pulsed vibrator, Other: Gait Trainer Treadmill (GTT), Other: Standard psychiatric scales SCID-I, YBOCS and SCI-OBS-lifetime and cognitive scales MMSE and MOCA, Device: iMobility, Device: QMAT, Diagnostic Test: Treadmill Test, Device: Arm Intellistretch Device, Procedure: Transcranial Sonography (TCS), Other: Behavioral tasks, Procedure: TMS single/paired pulse, Procedure: MEG, Procedure: EEG, Procedure: MRI techniques, Procedure: Peripheral Nerve Stimulation, Procedure: EMG, Procedure: Trancutaneous spinal direct current stimulation (tsDCS)Subjects diagnosed with movement disorder |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients will either have a well-defined diagnosis or be a diagnostic dilemma, depending upon the sub-study
- Age 18 or older
- Able to give informed consent
- Agree to not drink caffeine or alcohol for 48 hours before certain study sessions because both agents can modify brain activity and may confound outcome measures.
- Age 18 or older.
Key exclusion criteria (24 listed)
- Have used illegal drugs within the past 6 months
- Have more than 7 alcoholic drinks a week in the case of a woman or 14 alcoholic drinks a week in the case of a man.
- Have had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures.
- Have a psychotic disorder, Bipolar Disorder or a current depressive episode.
- Have another neurologic disorder than a movement disorder
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 |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Transcranial direct current stimulation involves the application of weak direct currents, delivered between two surface electrodes, placed over the scalp. | Procedure or surgery | Healthy Volunteers, Movement Disorder |
| Eye-tracking DeviceThe purpose of this device is to assess eye movement. Participants may sit down in front of a computer screen or a real-world environment, stand on a treadmill, or lie down in an MRI scanner. Small infrared cameras attached to the cap or glasses will be positioned in front of their eyes. Eye tracking might be performed alone, or in conjunction with EEG, EMG, fMRI or treadmill. The eye- tracking device is FDA approved and commercially available. | Device | Healthy Volunteers, Movement Disorder |
| Pulsed vibratorThis device would be used in experiments to see if gait can be improved and, if so, what parameters of stimulation are optimal. | Device | Healthy Volunteers, Movement Disorder |
| Gait Trainer Treadmill (GTT)The Gait Trainer is a specialized rehabilitation treadmill, which operates in both the forward and backwards mode allowing subjects to both train and undergo performance tasks in a relatively safe and expedient manner. The GTT is equipped with a mounted deck with built in sensors which monitors and records subjects gait speed, step length, right to left time distribution, and symmetry in real time in both forward and reverse modes. | Other | Healthy Volunteers, Movement Disorder |
| Standard psychiatric scales SCID-I, YBOCS and SCI-OBS-lifetime and cognitive scales MMSE and MOCAScales of motor function, cognitive function and psychiatric function are valuable supplements to clinical assessments of patients, giving quantitative information concerning these different aspects of brain function. Selected scales would be used only when potentially useful in a sub-study where such quantitative information would be correlated with a physiological or imaging result. | Other | Healthy Volunteers, Movement Disorder |
| iMobilityThis test uses the iMobility system. iMobility Device is a small device designed to measure movement through sensors (test monitors) worn by a patient via Velcro straps around an ankle or wrist or worn as a pendant around the neck to lie over the sternum. The device is a nonsignificant risk device.The iMobility Device has been used before, in the same format with a similar paradigm, in previous NIH studies. | Device | Healthy Volunteers, Movement Disorder |
| QMATThe purpose of this study is to assess the ability of the QMAT (quantitative motor assessment tool) to assess slowness of movement associated with Parkinson Disease. The QMAT device is FDA approved and has been used before, in the same format with a similar paradigm, in previous NIH studies. | Device | Healthy Volunteers, Movement Disorder |
| Treadmill TestSubjects will be fitted in a weight support harness for safety. Sensors will be placed on the subject s shoes and harness. The sensors (VICON system) will be used to record their stride length, position and velocity as they walk on a treadmill. This system is a motion-tracking system that is designed to measure various aspects of a person s gait. | Diagnostic test | Healthy Volunteers, Movement Disorder |
| Arm Intellistretch DeviceThe purpose of the Arm Intellistretch device is to objectively quantify wrist tone. It is used for rehabilitation applications in hospitals and office settings. Currently, rigidity is evaluated clinically using a subjective scale, zero to four and is part of the UPDRS. The Arm Intellistretch device is manufactured by Rehabtek, Inc., is FDA approved, and has been determined to be a non-significant risk device by the CNS IRB. | Device | Healthy Volunteers, Movement Disorder |
| Transcranial Sonography (TCS)Transcranial sonography will be conducted by a physician in the Clinical Center using the Acuson Antares ultrasound machine. This techniques uses ultrasound signals to image the brain. It entails having the subject sit in a chair or lay in a bed while the sonographer places a lubricated 2-inch ultrasound probe over the skin of the temporal area just above the patient s ear. Ultrasound images are then recorded. The procedure is not invasive and will last about 45 minutes. | Procedure or surgery | Healthy Volunteers, Movement Disorder |
| Behavioral tasksTo assess the changes in cerebral physiology in the brain, subjects will be presented sensory stimuli (e.g., primary visual stimulation with flashing lights or checkerboard, auditory with tone or speech, or olfactory stimuli), or will be asked to perform non-exercise motor tasks (e.g., tapping of fingers, squeezing ball, moving joystick), to perform cognitive tasks such as a working memory task (e.g., n-back with or without catch rules, word finding), or to just rest or sleep. | Other | Healthy Volunteers, Movement Disorder |
| TMS single/paired pulseFor MEP acquisition during TMS, electrodes will be placed over the belly and the tendon of the distal muscles of the hand or foot and/or proximal muscles (see sub-section EMG 7.1.3.1 for the details of the procedure). | Procedure or surgery | Healthy Volunteers, Movement Disorder |
| MEGMEG recordings will be performed together with experienced personnel in the NIMH MEG lab in the NMR center in Building 10. For these recording sessions, subjects will sit in a chair or lay down with a helmet placed over the head. The helmet used for MEG does not require the application of conductive gel. Scan times vary from 20 minutes to 2 hours. | Procedure or surgery | Healthy Volunteers, Movement Disorder |
| EEGEEGs will be recorded by, or together with, experienced personnel in the HMCS EEG lab in Building 10, or in the NMR center. | Procedure or surgery | Healthy Volunteers, Movement Disorder |
| MRI techniquesMRI sub-studies will be conducted on 3.0 T or 7T units in the NMR Research Center. All volunteers will comply with the yearly requirement of a standard clinical diagnostic MRI scan of the head performed at 3.0T, to be submitted to the Diagnostic Radiology Department of the Clinical Center for interpretation. If the subject does not have a clinical scan performed within 12 month of the exam, a standard clinical MRI will be performed and reviewed before the research MR. The standard examination takes approximately 15 minutes to complete; after that, the research MR scans will be performed. Standard clinical MRI of the head will be repeated on an annual basis and read by the Diagnostic Radiology Department of the Clinical Center. | Procedure or surgery | Healthy Volunteers, Movement Disorder |
| Peripheral Nerve StimulationConstant-current, 0.1 to 0.5 ms square-wave single pulses of electrical stimulation will be delivered through standard bar electrodes to nerves of the upper limb or of the lower limb. To study somatosensory evoked potentials, for example, the stimulus intensity will be set at just above the motor threshold for evoking a slight limb movement. Location of the electrical stimulation will depend on the specific objective of the sub-study. Peripheral nerve stimulation might be delivered during other types of experiments as well. | Procedure or surgery | Healthy Volunteers, Movement Disorder |
| EMGEMG measures the electrical activity of muscles. For our research purposes, only surface EMG will be used to measure the effects of central and peripheral nervous system stimulation. For surface EMG, electrodes will be coated with a conductive gel and taped to the skin. For motor evoked potential (MEP) acquisition during TMS, electrodes will be placed over the belly and the tendon of the distal muscles of the hand or foot and/or proximal muscles. | Procedure or surgery | Healthy Volunteers, Movement Disorder |
| Trancutaneous spinal direct current stimulation (tsDCS)Direct current (DC) stimulation is a non invasive tool used to promote plasticity of the central nervous system. Recently, DC stimulation has been applied to the human spinal cord, and known as transcutaneous spinal direct current stimulation (tsDCS). | Procedure or surgery | Healthy Volunteers, Movement Disorder |
Primary outcome
MRI
Time frame: throughout
analyze measures such as the amplitude of the BOLD signal (fMRI); tractography between seed and target regions of interest (using DTI); morphometry of brain regions (using VBM); and different neurotransmitter levels in brain regions of interest (using MRS).
EEG and MEG
Time frame: throughout
quantify measures such as event- or task-related potentials, synchronization/desynchronization, and coherence between sensors or sources located close to the brain areas of interest.
TMS
Time frame: throughout
analyze measures such as MEP amplitude and central conduction time.
Behavioral measures
Time frame: throughout
quantify measures such as reaction times to initiate movements, EMG patterns, movement kinematics (position, velocity, acceleration, curvature), eye movement.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication.
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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.
Avindra Nath, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS), Eye-tracking Device and Pulsed vibrator in people with Parkinson's Disease and Tourette's Syndrome, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 7 inclusion and 24 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: finished, as of the sponsor's last update on 5 Nov 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MRI (time frame: throughout). The study lists 4 primary outcomes in all. 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 5 Nov 2026.