Feasibility and Efficacy of rTMS in Healthy Persons

NCT04074811 | Withdrawn FDA Device

• 1 other identifier: TPD-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Executive Dysfunction; Pain; Mood

Outcome Measures

Primary Outcomes (4)

• Stroop Task (cognitive control)

  Examine the effect of rTMS stimulation on cognitive control as measured by the Stroop Color-Word task.

  Change from pre- to 25-minutes post-rTMS stimulation in each session

• Stop Signal Task (impulsivity)

  Examine the effect of rTMS stimulation on impulsivity as measured by the Stop Signal Task.

  Change from pre- to 15-minutes post-rTMS stimulation in each session

• Pain Sensitivity

  Examine the effect of rTMS stimulation on pain sensitivity as measured by thermal quantitative sensory threshold (QST) testing.

  Change from pre- to 50-minutes post-rTMS stimulation in each session

• Delay Discounting Task (cognitive control)

  Examine the effect of rTMS stimulation on cognitive control as measured by the brief (2-min) monetary delay discounting task

  Change from pre- to 10-minutes post-rTMS stimulation in each session

Secondary Outcomes (4)

• Effort Choice Task (motivation)

  Change from pre- to 30-minutes post-rTMS stimulation in each session

• Mood

  Change from pre- to 5-minutes post-rTMS stimulation in each session

• Peripheral Biomarkers

  Change from pre- to 0-minutes post-rTMS stimulation in each session

• Monetary Incentive Delay Task (motivation)

  Change from pre- to 40-minutes post-rTMS stimulation in each session

Study Arms (2)

Sham rTMS

SHAM COMPARATOR

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)

Active rTMS

ACTIVE COMPARATOR

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)

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS) DEVICE

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 rTMS; Sham rTMS

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy
• Right handed
• 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"

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Mark K Greenwald, PhD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Associate Department Chair

Model Details: This pilot study will use a single-blind, left dorsolateral prefrontal cortex (10-Hz) vs. sham, 2-session, within-subjects randomized crossover design.

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 30, 2019
• Study Start: April 10, 2023
• Primary Completion: April 10, 2023
• Study Completion: April 10, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)