Trial Outcomes & Findings for Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA) (NCT NCT05295953)

NCT ID: NCT05295953

Last Updated: 2025-10-22

Results Overview

Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: On Day 1 of the study
• Results posted on: 2025-10-22

Participant Flow

Participant milestones

Measure	TBS (Theta Burst Stimulation) Four sessions of TBS in one day TBS: Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan.	Sham TMS Four sessions of sham TMS Sham TMS: Four sessions of sham TMS delivered using MagVenture B65 A/P coil.
Overall Study STARTED	2	2
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	TBS (Theta Burst Stimulation) Four sessions of TBS in one day TBS: Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan.	Sham TMS Four sessions of sham TMS Sham TMS: Four sessions of sham TMS delivered using MagVenture B65 A/P coil.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Accelerated Transcranial Magnetic Stimulation (TMS) for Smoking Cessation in People Living With HIV/AIDS (PLWHA)

Baseline characteristics by cohort

Measure	TBS (Theta Burst Stimulation) n=2 Participants Four sessions of TBS in one day TBS: Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan.	Sham TMS n=2 Participants Four sessions of sham TMS Sham TMS: Four sessions of sham TMS delivered using MagVenture B65 A/P coil.	Total n=4 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	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	51.5 years STANDARD_DEVIATION 10.6 • n=5 Participants	40.7 years STANDARD_DEVIATION 1.4 • n=7 Participants	45.25 years STANDARD_DEVIATION 9.5 • 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	2 Participants n=5 Participants	2 Participants n=7 Participants	4 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 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
Region of Enrollment United States	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: On Day 1 of the study

Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome

Outcome measures

Measure	TBS (Theta Burst Stimulation) n=2 Participants Four sessions of TBS in one day TBS: Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan.	Sham TMS n=1 Participants Four sessions of sham TMS Sham TMS: Four sessions of sham TMS delivered using MagVenture B65 A/P coil.
Gaze Fixation on Smoking Cues	320.19 milliseconds Standard Deviation 234.83	152.60 milliseconds Standard Deviation NA ONLY ONE PARTICIPANT DATA ANALYZED

PRIMARY outcome

Timeframe: On Day 1 of the study after intervention

Measured using an eye tracker which quantifies this in milliseconds, higher score means worse outcome

Outcome measures

Measure	TBS (Theta Burst Stimulation) n=2 Participants Four sessions of TBS in one day TBS: Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan.	Sham TMS n=1 Participants Four sessions of sham TMS Sham TMS: Four sessions of sham TMS delivered using MagVenture B65 A/P coil.
Gaze Fixation on Smoking Cues	221.75 milliseconds Standard Deviation 94.24	120.50 milliseconds Standard Deviation NA Only one participant's data analyzed

PRIMARY outcome

Timeframe: On day one of the study.

Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 84, min score is 0. Higher score means that craving is higher.

Outcome measures

Measure	TBS (Theta Burst Stimulation) n=2 Participants Four sessions of TBS in one day TBS: Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan.	Sham TMS n=1 Participants Four sessions of sham TMS Sham TMS: Four sessions of sham TMS delivered using MagVenture B65 A/P coil.
Craving for Cigarettes	58 units on a scale Standard Deviation 5.66	50 units on a scale Standard Deviation NA Only one participant's data analyzed

PRIMARY outcome

Timeframe: Immediately after intervention (sessions of TBS or sham TMS) on day 1

Measured using tobacco craving questionnaire (TCQ), this questionnaire has 12 items. Max score is 84, min score is 0. Higher score means that craving is higher.

Outcome measures

Measure	TBS (Theta Burst Stimulation) n=2 Participants Four sessions of TBS in one day TBS: Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan.	Sham TMS n=1 Participants Four sessions of sham TMS Sham TMS: Four sessions of sham TMS delivered using MagVenture B65 A/P coil.
Craving for Cigarettes	51 units on a scale Standard Deviation 1.41	28 units on a scale Standard Deviation NA Only one participant's data analyzed

SECONDARY outcome

Timeframe: on Day 1 of study

Changes in functional connectivity on a functional MRI brain scan.

Outcome measures

Measure	TBS (Theta Burst Stimulation) n=2 Participants Four sessions of TBS in one day TBS: Four sessions of TBS at 120 % resting motor threshold, delivered using MagVenture B65 A/P coil, each lasting 10 minutes and separated by 50 minutes intervals. Targeting will be done using neuronavigation and processed resting state brain scan.	Sham TMS n=1 Participants Four sessions of sham TMS Sham TMS: Four sessions of sham TMS delivered using MagVenture B65 A/P coil.
Number of Participants Showing Functional Connectivity Changes	2 Participants	1 Participants

Adverse Events

TBS (Theta Burst Stimulation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham TMS

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

Gopalkumar Rakesh MD

University of Kentucky, Lexington

Phone: 859-257-9402

Email: gopalkumar.rakesh@uky.edu

Results disclosure agreements

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