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Feasibility and Efficacy of rTMS in Healthy Persons (TPD)

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: NCT04074811
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Greenwald, PhD, Wayne State University

Brief Summary:
Transcranial magnetic stimulation (TMS) is a neuromodulation device that is FDA-approved for use in treating depression and obsessive compulsive disorder. TMS works by applying a safe, electromagnetic field on the scalp, which can either increase or decrease neuronal communication and activity (depending on the mode of stimulation). Although it is only approved for two disorders, there has been substantial research into the potential of TMS to treat a wide range of neuropsychiatric disorders, including substance use disorders (SUDs). This project aims to develop an initial TMS protocol in a sample of healthy controls and to establish the feasibility and efficacy of using repetitive TMS (rTMS) to impact several carefully-selected cognitive, behavioral, and physiologic measures. This pilot project will enable the research team to gather baseline data using this new method and to plan longer-term programmatic studies focusing on populations with SUDs. The overarching aim of this project is to develop an rTMS protocol for use in the human laboratory setting with both healthy controls and individuals with SUDs. The investigators also hope to learn about the impact of high frequency rTMS over the DLPFC on multiple aspects of functioning including: cognitive control, impulsivity, thermal pain sensitivity, motivation, and mood.

Condition or disease Intervention/treatment Phase
Executive Dysfunction Pain Mood Device: Repetitive Transcranial Magnetic Stimulation (rTMS) Not Applicable

Detailed Description:

The short-term goal of this pilot project is to establish the feasibility and efficacy of repetitive transcranial magnetic stimulation (rTMS) on cognitive, behavioral, and physiological measures in a healthy community-recruited sample to plan longer-term programmatic studies focusing on substance use disorder (SUD) populations. Primary Aims are to examine the effect of one session of left dorsolateral prefrontal cortex (DLPFC) rTMS high-frequency (10 Hz) stimulation vs. placebo stimulation (no electromagnetic field but similar auditory and tactile sensations) on: (1) cognitive control, (2), impulsivity, and (3) thermal pain sensitivity. Secondary Aims are to test effects of rTMS on behavioral motivation (monetary incentive delay task, effort choice task), mood (PANAS), peripheral biomarkers (prolactin, BDNF) and collect biosamples for future genotyping.

The investigators recognize the proposed sample size is relatively small to adequately power a full analysis across all outcomes, so will use this study to determine effect sizes for any differences to plan future studies with adequate power. Generally speaking, data will be analyzed using repeated measures ANCOVAs; covariates will include TMS resting motor threshold, sex, and age. Based on sample size calculations, the investigators intend to complete up to 30 subjects. For some outcomes, the results of previous studies indicate that a lower sample size may be appropriate, therefore the investigators will conduct interim analyses at n=18 to calculate effect sizes to determine how many more participants are needed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This pilot study will use a single-blind, left dorsolateral prefrontal cortex (10-Hz) vs. sham, 2-session, within-subjects randomized crossover design.
Masking: Single (Participant)
Masking Description: Participants will be blinded to the use of active vs. sham rTMS. For the sham condition, the investigators will use a placebo figure-of-8 coil, which looks identical to the active coil, allows the same scalp placement, and produces the same auditory and tactile sensations as active stimulation without affecting cortical excitability.
Primary Purpose: Basic Science
Official Title: Exploring the Feasibility and Efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) in a Healthy Population
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
Sham Comparator: Sham rTMS
Sham rTMS will be applied over the left dorsolateral prefrontal cortex using a sham figure of 8 coil (within-subject crossover). Sham rTMS will consist of the same auditory and tactile stimuli as the active condition, but does not induce an electromagnetic field and does not affect cortical excitability.
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
The investigators will use the Figure of 8 coil, which affects ~10cm2 of cortical surface. The active condition will deliver stimulation at 110% of resting motor threshold (RMT). To determine RMT, the protocol will be: 10 trials of single-pulse TMS on the scalp position of the abductor pollicis brevis muscle (which controls thumb flexion); RMT is the lowest TMS power setting yielding visible motor contraction on >50% of trials.

Active Comparator: Active rTMS
Active rTMS will be applied over the left dorsolateral prefrontal cortex using an active figure of 8 coil (within-subject crossover). In the active rTMS condition, the investigators will use high-frequency (10Hz) dorsolateral prefrontal cortex (dlPFC) stimulation with intensity of 110% of resting motor threshold. rTMS will consist of 120 trains with 50 stimuli per train (i.e. 5-sec long at 10 Hz) and 10-sec intertrain interval for a total of 6000 pulses. The entire protocol will last 30 min (120 trains with 5-sec on/10-sec off).
Device: Repetitive Transcranial Magnetic Stimulation (rTMS)
The investigators will use the Figure of 8 coil, which affects ~10cm2 of cortical surface. The active condition will deliver stimulation at 110% of resting motor threshold (RMT). To determine RMT, the protocol will be: 10 trials of single-pulse TMS on the scalp position of the abductor pollicis brevis muscle (which controls thumb flexion); RMT is the lowest TMS power setting yielding visible motor contraction on >50% of trials.




Primary Outcome Measures :
  1. Stroop Task (cognitive control) [ Time Frame: Change from pre- to 25-minutes post-rTMS stimulation in each session ]
    Examine the effect of rTMS stimulation on cognitive control as measured by the Stroop Color-Word task.

  2. Stop Signal Task (impulsivity) [ Time Frame: Change from pre- to 15-minutes post-rTMS stimulation in each session ]
    Examine the effect of rTMS stimulation on impulsivity as measured by the Stop Signal Task.

  3. Pain Sensitivity [ Time Frame: Change from pre- to 50-minutes post-rTMS stimulation in each session ]
    Examine the effect of rTMS stimulation on pain sensitivity as measured by thermal quantitative sensory threshold (QST) testing.

  4. Delay Discounting Task (cognitive control) [ Time Frame: Change from pre- to 10-minutes post-rTMS stimulation in each session ]
    Examine the effect of rTMS stimulation on cognitive control as measured by the brief (2-min) monetary delay discounting task


Secondary Outcome Measures :
  1. Effort Choice Task (motivation) [ Time Frame: Change from pre- to 30-minutes post-rTMS stimulation in each session ]
    Examine the effect of rTMS stimulation on behavioral responding as measured by the Effort Choice Task (number of responses on progressive ratio vs. fixed ratio schedules of reinforcement).

  2. Mood [ Time Frame: Change from pre- to 5-minutes post-rTMS stimulation in each session ]
    Examine the effect of rTMS stimulation on mood state as measured by the Positive and Negative Affect Schedule.

  3. Peripheral Biomarkers [ Time Frame: Change from pre- to 0-minutes post-rTMS stimulation in each session ]
    Examine the effect of rTMS stimulation on peripheral biomarkers as measured by the plasma concentrations (ng/ml) of brain derived neurotrophic factor (BDNF) and prolactin.

  4. Monetary Incentive Delay Task (motivation) [ Time Frame: Change from pre- to 40-minutes post-rTMS stimulation in each session ]
    Examine the effect of rTMS stimulation on behavioral responding as measured by the Monetary Incentive Delay Task



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Right handed
  • 21-60 years of age
  • IQ score greater than 80
  • Eligible if using tobacco, alcohol, or marijuana fewer than 3 times per week; each "time" must be less than 3 cigarettes or drinks, or less than 1 marijuana "joint"

Exclusion Criteria:

  • Under influence of any substances during any session
  • Use of illicit substances in the past 30 days
  • Pregnant
  • Medical conditions that prohibit the use of rTMS (e.g. history of seizures or medications that lower seizure threshold)
  • Current DSM-5 Axis I psychiatric disorders, or any history of substance use disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04074811


Contacts
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Contact: Tabitha Moses 313-993-7157 tmoses@med.wayne.edu

Locations
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United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Mark K Greenwald, PhD    313-993-3965    mgreen@med.wayne.edu   
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Mark K Greenwald, PhD Wayne State University
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Responsible Party: Mark Greenwald, PhD, Professor and Associate Department Chair, Wayne State University
ClinicalTrials.gov Identifier: NCT04074811    
Other Study ID Numbers: TPD-1
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The research team is committed to disclosing and sharing scientific findings as outlined by NIH policy guidance on Sharing Research Data and on Sharing Model Organisms (see: http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#time). We note that, "NIH recognizes that the investigators who collected the data have a legitimate interest in benefiting from their investment of time and effort. NIH continues to expect that the initial investigators may benefit from first and continuing use but not from prolonged exclusive use." The research team (PI, with advice from co-investigators) plans to share data from this project as follows. We will disseminate data using conventional means including published abstracts, conference presentations (posters and talks), news releases, and peer reviewed journal articles.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Findings from the proposed investigation will be provided to the scientific community as rapidly as possible, given the usual constraints of careful data checking, analysis, and peer review.
Access Criteria: Qualified researchers may request in writing additional protocol materials from the PI.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No