Trial Outcomes & Findings for Brain Imaging of rTMS Treatment for Depression (NCT NCT01829165)

Last Updated: 2018-04-10

Results Overview

The Hamilton Depression Rating Scale (HAM-D) is a 24-item clinician-administered assessment utilized as a way of determining a patient's level of depression before, during, and after treatment. It takes approximately 15-20 minutes to complete the interview and score the results. Subscale scores are 0-2 (10 questions), 0-3 (2 questions), and 0-4 (12 questions). Subscales are totaled for an overall score (range 0 -76). For the overall score and all subscales, lower scores correspond to fewer symptoms, and higher scores correspond more symptoms.

Recruitment status

COMPLETED

Study phase

Target enrollment

85 participants

Primary outcome timeframe

Baseline; Day 10; Day 20

Results posted on

2018-04-10

Participant Flow

85 participants were enrolled and 33 were randomized.

Participant milestones

Participant milestones
Measure	rTMS Treatment Rapid transcranial magnetic stimulation (rTMS) was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own functional magnetic resonance imaging (fMRI) images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects. rTMS Treatment: MRI-compatible TMS stimulator	Sham Treatment Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sham sessions for adverse events and/or side effects. Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol. rTMS Treatment: MRI-compatible TMS stimulator
Overall Study STARTED	20	13
Overall Study COMPLETED	18	13
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	rTMS Treatment Rapid transcranial magnetic stimulation (rTMS) was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own functional magnetic resonance imaging (fMRI) images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects. rTMS Treatment: MRI-compatible TMS stimulator	Sham Treatment Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sham sessions for adverse events and/or side effects. Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol. rTMS Treatment: MRI-compatible TMS stimulator
Overall Study Did not complete intervention	2	0

Baseline Characteristics

Brain Imaging of rTMS Treatment for Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rTMS Treatment n=20 Participants rTMS was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own fMRI images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects. rTMS Treatment: MRI-compatible TMS stimulator	Sham Treatment n=13 Participants Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sham sessions for adverse events and/or side effects. Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol. rTMS Treatment: MRI-compatible TMS stimulator	Total n=33 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	20 Participants n=5 Participants	13 Participants n=7 Participants	33 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	37.2 years STANDARD_DEVIATION 11.2 • n=5 Participants	35.0 years STANDARD_DEVIATION 6.5 • n=7 Participants	36.2 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	4 Participants n=7 Participants	13 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	5 Participants n=5 Participants	3 Participants n=7 Participants	8 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	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	9 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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
Hamilton Depression Rating Scale (HAM-D 24)	27.0 units on a scale STANDARD_DEVIATION 8.0 • n=5 Participants	26.2 units on a scale STANDARD_DEVIATION 5.9 • n=7 Participants	26.9 units on a scale STANDARD_DEVIATION 7.1 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline; Day 10; Day 20

Population: Randomized and treated

Outcome measures

Outcome measures
Measure	rTMS Treatment n=20 Participants rTMS was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own fMRI images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects. rTMS Treatment: MRI-compatible TMS stimulator	Sham Treatment n=13 Participants Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sham sessions for adverse events and/or side effects. Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol. rTMS Treatment: MRI-compatible TMS stimulator
Clinician Administered HAM-D Baseline	27.0 units on a scale Standard Deviation 8.0	26.2 units on a scale Standard Deviation 5.9
Clinician Administered HAM-D Day 10	22.0 units on a scale Standard Deviation 9.3	22.7 units on a scale Standard Deviation 6.9
Clinician Administered HAM-D Day 20	17.9 units on a scale Standard Deviation 9.9	17.6 units on a scale Standard Deviation 9.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 months.

From pre- to post-treatment, improvement will be based on enhanced functional connectivity.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 months

Implicit emotion regulation assessed through emotion conflict task performed during functional imaging. Performance based on reaction time and recruitment of emotion regulation regions during the task.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 months.

From pre- to post-treatment of patients with high-frequency repetitive TMS (rTMS) improvement shall be measured by normalization of baseline network-level deficits.

Outcome measures

Outcome data not reported

Adverse Events

rTMS Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Sham Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	rTMS Treatment n=20 participants at risk rTMS was to be delivered for 20 sessions over 4 weeks. Active 10 Hz rTMS was delivered using neuro-navigation based on participants' own fMRI images. Daily treatment regiments were to last 36.5 minutes and rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sessions for adverse events and/or side effects. rTMS Treatment: MRI-compatible TMS stimulator	Sham Treatment n=13 participants at risk Sham rTMS was to be delivered for 20 sessions over 4 weeks. Placebo 10Hz rTMS was delivered through sham stimulation electrodes. The rTMS coil was positioned using neuro-navigation based on participants' own fMRI images, mimicking active rTMS treatment. Daily treatment regiments were to 36.5minutes and sham rTMS was delivered at 120% of the participant's motor threshold. Participants were monitored during the rTMS sham sessions for adverse events and/or side effects. Upon completing the sham 20 sessions participants are unblinded and offered 20 further treatments of guaranteed open-label treatment. The open-label treatment would follow the active rTMS treatment protocol. rTMS Treatment: MRI-compatible TMS stimulator
Nervous system disorders Startled by rTMS device	5.0% 1/20 • Up to 9 months Randomized and treated population	0.00% 0/13 • Up to 9 months Randomized and treated population
General disorders Abdominal Cramping Pain	0.00% 0/20 • Up to 9 months Randomized and treated population	7.7% 1/13 • Up to 9 months Randomized and treated population
Vascular disorders Hypotension	0.00% 0/20 • Up to 9 months Randomized and treated population	7.7% 1/13 • Up to 9 months Randomized and treated population

Additional Information

Amit Etkin, MD, PhD

Stanford University

Phone: (650) 725-5736

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place