Trial Outcomes & Findings for Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation (NCT NCT04228276)

NCT ID: NCT04228276

Last Updated: 2025-08-29

Results Overview

Rate of stimulant use relapse compared between active vs. sham rTMS groups

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: 3 months after last rTMS treatment
• Results posted on: 2025-08-29

Participant Flow

8 people did not enter intervention phase. Defining drop out as those who started the intervention and dropped out before completing intervention & outcome measures.

Participant milestones

Measure	Active rTMS Receive active rTMS Repetitive transcranial magnetic stimulation (rTMS): rTMS is a non-invasive procedure which administers a transient magnetic field inducing electrical currents in specific, targeted brain regions. The intervention was administered in 8 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.	Sham rTMS All subjects underwent the same procedure as the active rTMS group except that the inactive side of the coil was placed on the subject's scalp. The experience receiving sham rTMS was identical except that no electrical current was administered.
Overall Study STARTED	9	13
Overall Study COMPLETED	7	11
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treating Stimulant Addiction With Repetitive Transcranial Magnetic Stimulation

Baseline characteristics by cohort

Measure	Active rTMS n=7 Participants Receive active rTMS Repetitive transcranial magnetic stimulation (rTMS): rTMS is a non-invasive procedure which administers a transient magnetic field inducing electrical currents in specific, targeted brain regions. The intervention was administered in 8 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.	Sham rTMS n=11 Participants All subjects underwent the same procedure as the active rTMS group except that the inactive side of the coil was placed on the subject's scalp. The experience receiving sham rTMS was identical except that no electrical current was administered.	Total n=18 Participants Total of all reporting groups
Age, Continuous	40.4 Year STANDARD_DEVIATION 11.3 • n=5 Participants	45.0 Year STANDARD_DEVIATION 16.9 • n=7 Participants	43.2 Year STANDARD_DEVIATION 15.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months after last rTMS treatment

Rate of stimulant use relapse compared between active vs. sham rTMS groups

Outcome measures

Measure	Active rTMS n=7 Participants Receive active rTMS Repetitive transcranial magnetic stimulation (rTMS): rTMS is a non-invasive procedure which administers a transient magnetic field inducing electrical currents in specific, targeted brain regions. The intervention was administered in 8 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.	Sham TMS n=11 Participants All subjects underwent the same procedure as the active rTMS group except that the inactive side of the coil was placed on the subject's scalp. The experience receiving sham rTMS was identical except that no electrical current was administered.
Number of Participants Relapsed	4 Participants	8 Participants

SECONDARY outcome

Timeframe: Within 1 week before and after rTMS treatment

Population: Unable to conduct this portion of study due to COVID-19 pandemic related logistical challenges. Data will never be collected in the future.

Before and after treatment, participants underwent functional magnetic resonance imaging (fMRI) imaging while completing the Monetary Incentive Delay Task, a validated probe of reward processing circuit function and dysfunction. Signaling in the substantia nigra measured in an individual-subject, "native space" region of interest approach as a marker of dopaminergic reward processing function, as well as in voxel-wise, whole-brain exploratory analyses. Changes in reward function and signaling compared between active vs. sham rTMS groups

Outcome measures

Outcome data not reported

Adverse Events

Active rTMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham 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. Jong Yoon

Palo Alto VA

Phone: 6504935000

Email: jong.yoon@va.gov

Results disclosure agreements

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