Trial Outcomes & Findings for Effects of Connectivity-based rTMS and State-Dependency on Amygdala Activation (NCT NCT03746405)

NCT ID: NCT03746405

Last Updated: 2020-12-10

Results Overview

Blood oxygenation level dependent (BOLD) will be assessed to evaluate the acute effect of rTMS applied over the medial prefrontal cortex on the amygdala activation. This outcome (expressed a z-score) represents the amygdala activation, either after active rTMS or after sham rTMS. Higher z-scores for active than for sham rTMS indicates that amygdala activity increases after active rTMS compared to sham rTMS, on the other hand lower z-score after active rTMS vs. after Sham rTMS indicated that the amygdala activity would have been reduced with active rTMS.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: right after the rTMS session, up to one hour
• Results posted on: 2020-12-10

Participant Flow

Across the 25 enrolled participants, 7 were excluded after the first visit for different reasons such as: contraindications, too high resting motor threshold or technical difficulties

Participant milestones

Measure	Repetitive TMS (rTMS) excitatory rTMS applied over the medial prefrontal cortex (fMRI-guided) repetitive transcranial magnetic stimulation: excitatory 5Hz rTMS will be used	Sham Repetitive TMS (rTMS) electrical sham coil applied over the medial prefrontal cortex (fMRI-guided) Sham repetitive transcranial magnetic stimulation: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used
Overall Study STARTED	10	8
Overall Study COMPLETED	7	6
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	Repetitive TMS (rTMS) excitatory rTMS applied over the medial prefrontal cortex (fMRI-guided) repetitive transcranial magnetic stimulation: excitatory 5Hz rTMS will be used	Sham Repetitive TMS (rTMS) electrical sham coil applied over the medial prefrontal cortex (fMRI-guided) Sham repetitive transcranial magnetic stimulation: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used
Overall Study Withdrawal by Subject	3	0
Overall Study technical difficulties	0	2

Baseline Characteristics

Effects of Connectivity-based rTMS and State-Dependency on Amygdala Activation

Baseline characteristics by cohort

Measure	Repetitive TMS (rTMS) n=10 Participants excitatory rTMS applied over the medial prefrontal cortex (fMRI-guided) repetitive transcranial magnetic stimulation: excitatory 5Hz rTMS will be used	Sham Repetitive TMS (rTMS) n=8 Participants electrical sham coil applied over the medial prefrontal cortex (fMRI-guided) Sham repetitive transcranial magnetic stimulation: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Asian	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · White	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: right after the rTMS session, up to one hour

Population: Participants who completed the study

Blood oxygenation level dependent (BOLD) will be assessed to evaluate the acute effect of rTMS applied over the medial prefrontal cortex on the amygdala activation.

This outcome (expressed a z-score) represents the amygdala activation, either after active rTMS or after sham rTMS.

Higher z-scores for active than for sham rTMS indicates that amygdala activity increases after active rTMS compared to sham rTMS, on the other hand lower z-score after active rTMS vs. after Sham rTMS indicated that the amygdala activity would have been reduced with active rTMS.

Outcome measures

Measure	Repetitive TMS (rTMS) n=7 Participants excitatory rTMS applied over the medial prefrontal cortex (fMRI-guided) repetitive transcranial magnetic stimulation: excitatory 5Hz rTMS will be used	Sham Repetitive TMS (rTMS) n=6 Participants electrical sham coil applied over the medial prefrontal cortex (fMRI-guided) Sham repetitive transcranial magnetic stimulation: an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used
Acute Effect of a rTMS Session on Brain Activation as Measured by the Cerebral Blood Flow (Blood Oxygenation Level Dependent Signal)	0.67 z score in the amygdala Standard Deviation 0.48	-0.48 z score in the amygdala Standard Deviation 0.87

Adverse Events

Repetitive TMS (rTMS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Repetitive TMS (rTMS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Lysianne Beynel

Duke University

Phone: 919-681-1157

Email: lysianne.beynel@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place