TMSINS02: TMS Modulation of Insula-related Brain Networks.02

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02919423
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 13.8
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the modulatory effects of repetitive transcranial magnetic stimulation (rTMS) on functional connectivity with the insula. Functional connectivity (FC) measures the interaction between brain regions, and recent neuroimaging studies have used FC to investigate how addiction affects FC among pertinent brain regions. rTMS, which can excite cortical neurons, has shown promise as a method to manipulate brain connectivity and could be used therapeutically to treat addiction. However, investigators first need more information on brain FC and how it relates to behavior, in order to guide rTMS target selection.

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Device: transcranial magnetic stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: TMS Modulation of Insula-related Brain Networks.02
• Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: Jan 25, 2018
• Actual Study Completion Date: Jan 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 10 Hz TMS active TMS will be administered	Device: transcranial magnetic stimulation
Active Comparator: 1 Hz TMS active TMS will be administered	Device: transcranial magnetic stimulation

Outcome Measures

Primary Outcome Measures

1. Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging [baseline and 1 week]

   Difference in functional connectivity from the TMS target site to the right insula. The primary dependent variable was the resting-state functional connectivity strength between the TMS target site and the right insula.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• generally healthy

• between the ages of 18-55

• right-handed

Exclusion Criteria:

• significant health problems (e.g., current and uncontrolled liver, lung, or heart problems) or presence of medical illness likely to alter brain morphology (including history of seizure, history of epilepsy in self or first degree relatives, stroke, brain surgery, head injury, and known structural brain lesion)

• current diagnosis of Axis I psychiatric disorders (e.g., depression, anxiety disorder, schizophrenia)

• meet DSM-5 criteria for current substance use disorder other than nicotine

• use of psychoactive medications that would result in a positive urine drug screen

• Current use of medications known to lower the seizure threshold

• positive breath alcohol concentration

• presence of conditions that would make MRI unsafe (e.g., metal implants, pacemakers)

• among women, a positive urine pregnancy test

• vision that cannot be corrected to 20/40

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Merideth Addicott, PhD, Duke University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 21, 2016

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02919423
• Other Study ID Numbers: Pro00077293
• First Posted: Sep 29, 2016
• Last Update Posted: Feb 15, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Pre-assignment Detail	5 subjects were consented but did not meet eligibility criteria and were not randomized to a condition.

Arm/Group Title	10 Hz TMS	1 Hz TMS
Arm/Group Description	This group received 10 Hz TMS	This group received 1 Hz TMS
Period Title: Overall Study
STARTED	6	25
COMPLETED	4	16
NOT COMPLETED	2	9

Baseline Characteristics

Arm/Group Title	10 Hz TMS	1 Hz TMS	Total
Arm/Group Description	This group received 10 Hz TMS	This group received 1 Hz TMS	Total of all reporting groups
Overall Participants	6	25	31
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	27 (7)	31 (12)	30 (11)
Sex: Female, Male (Count of Participants)
Female	3 50%	18 72%	21 67.7%
Male	3 50%	7 28%	10 32.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 16.7%	3 12%	4 12.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	7 28%	7 22.6%
White	5 83.3%	14 56%	19 61.3%
More than one race	0 0%	1 4%	1 3.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	6 100%	25 100%	31 100%

Outcome Measures

1. Primary Outcome

Title	Change in Functional Connectivity Strength Measured With Functional Magnetic Resonance Imaging
Description	Difference in functional connectivity from the TMS target site to the right insula. The primary dependent variable was the resting-state functional connectivity strength between the TMS target site and the right insula.
Time Frame	baseline and 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	10 Hz TMS	1 Hz TMS
Arm/Group Description	This group received 10 Hz TMS	This group received 1 Hz TMS
Measure Participants	6	25
Number [correlation coefficient]	.25	.13

Adverse Events

Time Frame	1 year
Arm/Group Title	10 Hz TMS		1 Hz TMS
Arm/Group Description	This group received 10 Hz TMS		This group received 1 Hz TMS
All Cause Mortality
	10 Hz TMS		1 Hz TMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/25 (0%)
Serious Adverse Events
	10 Hz TMS		1 Hz TMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	10 Hz TMS		1 Hz TMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.