Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System
|First Received Date ICMJE||March 28, 2007|
|Last Updated Date||December 7, 2013|
|Start Date ICMJE||March 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00453505 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System|
|Official Title ICMJE||Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System|
This study will explore the effects of different combinations of brain, hand or leg stimulation on hand movement.
Healthy normal volunteers 18 years of age or older may be eligible for this study. Candidates are screened with a medical and neurological history and examination.
The study involves one to twenty 4-hour experimental sessions completed over 1 to 12 months. During each session, participants receive some combination of mild electrical peripheral nerve stimulation, magnetic transcranial stimulation (TMS), and electrical transcranial stimulation (TMS and tDCS, respectively). No more than two forms of stimulation are combined during any one session, with no more than 3 hours of stimulation during the session.
Each session includes some of the following tests:
Noninvasive stimulation of the central and peripheral nervous system, including transcranial magnetic stimulation (TMS), theta-burst TMS (TBS), transcranial direct current stimulation (tDCS) and peripheral nerve stimulation (PNS) alone or paired with TMS (paired associative stimulation, PAS), has been increasingly used in the investigation of cortical plasticity and as a possible adjuvant strategy in neurorehabilitation. It has been shown that TMS, TBS, tDCS and PNS can successfully modulate motor function in healthy volunteers, as well as in patients with neurological disorders such as stroke.
One fundamental problem is that the optimal parameters of stimulation to modulate motor function by all of these techniques are not known. The purpose of this protocol is to explore within safe guidelines, the effects of different stimulation parameters on motor cortical function, on oscillatory brain dynamics measured with magnetoencephalography (MEG) and electroencephalography (EEG), on eye movements, and on fMRI activation. In addition, this protocol will be used to train new fellows coming to NINDS Human Cortical Physiology Section (HCPS) in the use of TMS, TBS, tDCS, and PNS techniques.
We expect that information emerging from these studies will allow us to 1)optimize the stimulation parameters to collect pilot data in healthy volunteer for future patient-oriented hypothesis-driven protocols,2)to collect pilot data for power analysis for future patient-oriented hypothesis driven protocols, and 3) to train new fellows in the use of these different methods.
Up to 1000 healthy volunteers, age 18 and older.
Healthy volunteers will receive one or more of the following types of stimulation alone or in combination: (1) 1 Hz TMS for up to 30mins and up to 115% of resting motor threshold intensity (MT) (2) TBS below 100% active MT; (3) tDCS up to 2 mA for up to 60mins (4) PNS with intensities below 130% of the peripherally-elicited-motor-threshold for up to 2 hours. . All of these parameters of stimulation and procedures have safely been used as previously reported in the literature. Sham stimulations will be delivered for each modality.
Each subject may undergo up to 20 sessions spaced by at least one day, depending on the particular exploration. To verify that the number of sessions per subject does not exceed 20 sessions, the number of sessions per participant is tracked across substudies using CTDB. The AIs are responsible for entering into CTDB the subjects/visits. We will test the effects of these different forms of stimulation on motor cortical excitability, simple motor tasks, and functional neuroimaging measures. Some stimulation may be conducted before, after, or during fMRI scans, eye movement recording, MEG and/or EEG recording sessions. To identify the possible contribution of sub-cortical structures, we will also measure M-wave, F-wave, and/or H-Reflexes. The goal of these exploratory studies is to obtain preliminary information on the effects of these various combinations of central and peripheral nervous system stimulation that would allow us to develop subsequent, finely tuned, hypothesis-driven protocols. Hypothesis-driven studies started under this protocol will be limited to 6 subjects per group and accrual of subjects to these hypothesis-driven substudies will be tracked using CTDB.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1000|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00453505|
|Other Study ID Numbers ICMJE||070122, 07-N-0122|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||September 2013|
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