Transcranial Magnetic Stimulation During Cognitive Tasks for Healthy Subjects
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: University of Minnesota
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The study will examine whether the benefits of brain stimulation on mental functioning can be enhanced if an individual is actively engaging the target brain networks while receiving brain stimulation. The study includes two separate sessions and people will complete either a cognitive task or a perceptual task while receiving transcranial magnetic stimulation. The study will measure change in brain function with EEG.
Do I have to stop taking my current medications for this trial?
The trial does not specify if you must stop taking your current medications, but you cannot participate if you are currently using or have recently stopped using medications that can increase the risk of seizure.
What data supports the idea that Transcranial Magnetic Stimulation During Cognitive Tasks for Healthy Subjects is an effective treatment?
The available research shows that Transcranial Magnetic Stimulation (rTMS) can improve cognitive processing and attention in healthy subjects. One study found that rTMS significantly decreased reaction time and improved cognitive processing when applied to the left prefrontal cortex. Another study showed that rTMS improved attentional function by reducing reaction time and errors in performance tests. These findings suggest that rTMS can enhance certain cognitive functions in healthy individuals.
12345What safety data exists for transcranial magnetic stimulation?
Safety data for transcranial magnetic stimulation (TMS) and its repetitive form (rTMS) indicate that while it is generally safe, there are potential risks and side effects. Known risks include the possibility of inducing seizures, with 7 cases reported by 1996. Mild adverse effects such as headaches and nausea have been observed, and discomfort during stimulation can affect task performance. Guidelines have been developed to ensure safe use, including limits on stimulation parameters and monitoring of subjects. Studies have shown that when applied within these guidelines, TMS is relatively safe for healthy subjects, with no significant changes in neurological, cognitive, or motor functions observed in some trials.
678910Is transcranial magnetic stimulation a promising treatment for improving cognitive tasks in healthy people?
Yes, transcranial magnetic stimulation (TMS) is a promising treatment for improving cognitive tasks in healthy people. Studies show that TMS can enhance cognitive processing, improve attention, and reduce reaction times. It works by stimulating specific areas of the brain, which can lead to better performance in tasks that require thinking and memory.
123411Eligibility Criteria
This trial is for healthy individuals aged between 18 and 65. Participants should not be pregnant, have metal in their head (except dental fillings), diagnosed psychiatric disorders, epilepsy or history of seizures, recent concussions, adverse reactions to TMS/MRI, neurological conditions like stroke or tinnitus, or implanted medical devices.Inclusion Criteria
Healthy controls
I am between 18 and 65 years old.
Exclusion Criteria
Currently pregnant
Any metal in the head (excluding mouth)
I have epilepsy or have had a seizure before.
+8 more
Participant Groups
The study tests if engaging in cognitive or perceptual tasks while receiving transcranial magnetic stimulation (TMS) can enhance mental function. It involves two sessions where brain function changes are measured with EEG during the application of TMS.
1Treatment groups
Experimental Treatment
Group I: Healthy controlExperimental Treatment1 Intervention
All participants receive the same procedures
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
Intensity-dependent regional cerebral blood flow during 1-Hz repetitive transcranial magnetic stimulation (rTMS) in healthy volunteers studied with H215O positron emission tomography: II. Effects of prefrontal cortex rTMS. [2019]The changes in brain activity produced by repetitive transcranial magnetic stimulation (rTMS) of the prefrontal cortex (PFC) remain unclear. We examined intensity-related changes in brain activity with positron emission tomography (PET) in normal volunteers during rTMS delivered to the left PFC.
The impact of transcranial magnetic stimulation on cognitive processing: an event-related potential study. [2019]Several neuropsychological studies have shown that repetitive transcranial magnetic stimulation (rTMS) can improve cognitive processing. We performed a study on the impact of rTMS on cognitive processing as measured by a neurophysiological method. In 14 healthy subjects, visually evoked event-related potentials (ERP) and mean choice reaction time were measured before and after 20 Hz rTMS of the left and of the right prefrontal cortex. The data were compared to sham stimulation and to 1 Hz single TMS. P3 latencies and reaction time were significantly decreased by rTMS of the left but not of the right prefrontal cortex, single TMS did not have any significant impact on the ERP components. We conclude that the facilitating effects of rTMS on cognitive processing can be proven even by objective neurophysiological measures.
Attentional and neurophysiologic effects of repetitive transcranial magnetic stimulation. [2021]Twenty-seven healthy subjects were randomly assigned to 1 of 2 equal groups : (1) experimental group (active stimulation) and (2) control group (sham stimulation). A total of 10 Hz repetitive transcranial magnetic stimulation was delivered to the left dorsolateral prefrontal cortex at 80% of the resting motor threshold. The reaction time of the correct response, omission error, and commission error of the auditory and visual continuous performance test scores were measured. The motor evoked potentials, resting motor threshold, short-interval intracortical inhibition, and intracortical facilitation was recorded in the right first dorsal interosseous muscle to determine motor cortex excitability. The reaction time and commission error of the auditory continuous performance test were reduced significantly after 10 Hz repetitive transcranial magnetic stimulation (P < 0.05). Resting motor threshold and short-interval intracortical inhibition was significantly decreased after active repetitive transcranial magnetic stimulation (P < 0.05), with no changes in the latency and amplitude of the motor evoked potentials and intracortical facilitation. In conclusion, high-frequency repetitive transcranial magnetic stimulation to the left dorsolateral prefrontal cortex is shown to improve the attentional function and may be simultaneously associated with changes in neurophysiological activity.
Modulation of the neuronal circuitry subserving working memory in healthy human subjects by repetitive transcranial magnetic stimulation. [2022]We studied the effect of repetitive transcranial magnetic stimulation (rTMS) on changes in regional cerebral blood flow (rCBF) as revealed by positron emission tomography (PET) while subjects performed a 2-back verbal working memory (WM) task. rTMS to the right or left dorsolateral prefrontal cortex (DLPFC), but not to the midline frontal cortex, significantly worsened performance in the WM task while inducing significant reductions in rCBF at the stimulation site and in distant brain regions. These results for the first time demonstrate the ability of rTMS to produce temporary functional lesions in elements of a neuronal network thus changing its distributed activations and resulting in behavioral consequences.
Cognitive effects of high-frequency repetitive transcranial magnetic stimulation: a systematic review. [2022]Transcranial magnetic stimulation (TMS) was introduced as a non-invasive tool for the investigation of the motor cortex. The repetitive application (rTMS), causing longer lasting effects, was used to study the influence on a variety of cerebral functions. High-frequency (>1 Hz) rTMS is known to depolarize neurons under the stimulating coil and to indirectly affect areas being connected and related to emotion and behavior. Researchers found selective cognitive improvement after high-frequency (HF) stimulation specifically over the left dorsolateral prefrontal cortex (DLPFC). This article provides a systematic review of HF-rTMS studies (1999-2009) stimulating over the prefrontal cortex of patients suffering from psychiatric/neurological diseases or healthy volunteers, where the effects on cognitive functions were measured. The cognitive effect was analyzed with regard to the impact of clinical status (patients/healthy volunteers) and stimulation type (verum/sham). RTMS at 10, 15 or 20 Hz, applied over the left DLPFC, within a range of 10-15 successive sessions and an individual motor threshold of 80-110%, is most likely to cause significant cognitive improvement. In comparison, patients tend to reach a greater improvement than healthy participants. Limitations concern the absence of healthy groups in clinical studies and partly the absence of sham groups. Thus, future investigations are needed to assess cognitive rTMS effects in different psychiatric disorders versus healthy subjects using an extended standardized neuropsychological test battery. Since the pathophysiological and neurobiological basis of cognitive improvement with rTMS remains unclear, additional studies including genetics, experimental neurophysiology and functional brain imaging are necessary to explore stimulation-related functional changes in the brain.
Rapid rate transcranial magnetic stimulation--a safety study. [2019]We assessed the safety of repeated short trains (4 stimuli) of rapid-rate transcranial magnetic stimulation (rrTMS) over the left motor cortex in 6 healthy normal subjects. rrTMS involved two separate blocks of 50 consecutive trains of 4 stimuli at a frequency of 20 Hz and an intensity of 5-10% above active motor threshold. We monitored EEG, and assessed aspects of neurological (balance, gait, two-point discrimination, blood pressure, pulse rate), cognitive (attention, memory, executive function) and motor function (speed of movement initiation and execution and manual dexterity) before and after the two blocks of rrTMS. EMG was also recorded from a number of hand, forearm and arm muscles contralateral to the site of stimulation. Two blocks of repeated rrTMS at 20 Hz and 5-10% above active motor threshold did not produce any adverse effects. Measures of neurological, cognitive and motor function showed no change following rrTMS. From the EMG recording there was evidence of increase in the amplitude of the motor evoked potentials (MEPs) recorded from the biceps in one subject during the first block of rrTMS, but this did not occur in the second block. A similar magnification of MEPs was also observed in another subject only during the second block of stimulation. When applied using parameters falling within published guidelines (Pascual-Leone et al., 1993; Pascual-Leone et al., 1994), repeated rrTMS is a relatively safe technique in healthy normal subjects. As rrTMS allows disruption of cortical function for a longer period, it has the potential of becoming a particularly useful tool for the study of cognitive function as well as sensory or motor function.
Side effects of repetitive transcranial magnetic stimulation. [2005]The side effects of repetitive transcranial magnetic stimulation are largely unexplored and the limits of safe exposure have not been determined except as regards the acute production of seizures. Although tissue damage is unlikely, however, cognitive and other adverse effects have been observed and the possibility of unintended long-term changes in brain function are theoretically possible.
Comparative incidence rates of mild adverse effects to transcranial magnetic stimulation. [2022]Past research has largely neglected to investigate mild adverse effects (MAEs) to transcranial magnetic stimulation (TMS), including headache and nausea. Here we explored the relationship between MAEs, participant characteristics (age and gender) and protocol parameters, including mode of application, coil geometry, stimulated brain region, TMS frequency, TMS intensity, and active vs. sham stimulation.
Risk and safety of repetitive transcranial magnetic stimulation: report and suggested guidelines from the International Workshop on the Safety of Repetitive Transcranial Magnetic Stimulation, June 5-7, 1996. [2022]Single-pulse transcranial magnetic stimulation (TMS) is a safe and useful tool for investigating various aspects of human neurophysiology, particularly corticospinal function, in health and disease. Repetitive TMS (rTMS), however, is a more powerful and potentially dangerous modality, capable of regionally blocking or facilitating cortical processes. Although there is evidence that rTMS is useful for treating clinical depression, and possibly other brain disorders, it had caused 7 known seizures by 1996 and could have other undesirable effects. In June 1996 a workshop was organized to review the available data on the safety of rTMS and to develop guidelines for its safe use. This article summarizes the workshop's deliberations. In addition to issues of risk and safety, it also addresses the principles and applications of rTMS, nomenclature, and potential therapeutic effects of rTMS. The guidelines for the use of rTMS, which are summarized in an appendix, cover the ethical issues, recommended limits on stimulation parameters, monitoring of subjects (both physiologically and neuropsychologically), expertise and function of the rTMS team, medical and psychosocial management of induced seizures, and contra-indications to rTMS.
Side effects of transcranial magnetic stimulation biased task performance in a cognitive neuroscience study. [2019]Transcranial magnetic stimulation (TMS) is increasingly used as a research tool for functional brain mapping in cognitive neuroscience. Despite being mostly tolerable, side effects of TMS could influence task performance in behavioural TMS studies. In order to test this issue, healthy subjects assessed the discomfort caused by the stimulation during a verbal working memory task. We investigated the relation between subjective disturbance and task performance. Subjects were stimulated during the delay period of a delayed-match-to-sample task above cortical areas that had been identified before to be involved in working memory. Task performance and subjective disturbance due to side effects were monitored. The subjects' grade of discomfort correlated with the error rates: the higher the discomfort, the more errors were made. Conclusively, TMS side effects may bias task performance in cognitive neuroscience studies and may thereby lead to misinterpretation of results. We emphasize the importance of controlling side effects of the stimulation as a source of biasing effects in TMS studies.
Effect of different pulse numbers of transcranial magnetic stimulation on motor cortex excitability: Single-blind, randomized cross-over design. [2020]We aimed to investigate the effect of different pulse numbers of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the motor cortex on cortical excitability in healthy participants.