Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00453505|
Recruitment Status : Recruiting
First Posted : March 29, 2007
Last Update Posted : March 12, 2018
Noninvasive stimulation of the central and peripheral nervous system, including transcranial magnetic stimulation (TMS), theta-burst TMS (TBS), transcranial direct current stimulation (tDCS) and cutaneous/peripheral nerve stimulation (CPNS) 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 CPNS 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 CPNS 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). These parameters are not being used for single-pulse TMS and paired-pulse TMS. Parameters for single-pulse TMS and paired-pulse TMS are variable as they depend on the sub-study. For paired pulses, duration of each TMS pulse is up to 1 msec. Interval between pulses is up to 20 sec and intensity of stimulation is up to 100 % of stimulator s output depending on the sub-study. (2) TBS below 100% active MT; (3) tDCS up to 2 mA for up to 60mins (4) CPNS 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.
Under this protocol, we conduct:
Exploratory Sub-studies. These substudies are exploratory in nature and are conducted in order to develop information to generate better informed hypotheses and/or power analyses. We have set an upper limit of 40 subjects per sub-study.
Hypothesis-Testing Sub-studies. Hypothesis-testing sub-studies are studies with specific hypotheses to be tested. These sub-studies undergo statistical and PIRC review after 6 subjects per group (e.g., after 12 subjects, 6 per arm, if two groups are studied), before additional subjects can be recruited. Together, the P.I. and PIRC will decide whether to continue the sub-study with more subjects without an amendment or whether an amendment or protocol would be necessary. A memo requesting a review of hypothesis-testing sub-studies for possible additional enrollment (beyond 6) will be sent to PIRC and the statistical reviewer.
In addition to the sub-study types above, this protocol is used to train new investigators and optimize various techniques and experimental approaches (e.g., appropriate MRI sequences, parameters of TMS stimulation, behavioral training duration).
We devised a strategy to ensure that a sub-study engages only procedures authorized in protocol and consent form and is scientifically valuable. F......
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System|
|Study Start Date :||March 27, 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453505
|Contact: Marta Gozzi, Ph.D.||(301) firstname.lastname@example.org|
|Contact: Leonardo G Cohen, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Leonardo G Cohen, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|