Trial Outcomes & Findings for LFMS: Initial Trial in Geriatric Bipolar Depression (NCT NCT02707276)
NCT ID: NCT02707276
Last Updated: 2022-03-02
Results Overview
The Montgomery-Asberg Depression Rating Scale (MADRS) is a diagnostic assessment measuring the severity of depressive symptoms. It is a 10-item scale assessing all core symptoms of repression. Each item is scored on a 7-point scale, ranging from 0 (symptom not present) to 6 (symptom severely present). Thus, the total score range is 0-60, with higher scores indicating more depressive symptom endorsement.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Phase 1 cross-over: scores at base visit 1 (week 0), visit 5 (week 2), and visit 9 (week 4). Differences are between visits 5-1 and 9-5. Phase 2 parallel: scores at base visit 1 (day 0) and visit 7 (day 10). Differences are between visits 7-1.
Results posted on
2022-03-02
Participant Flow
Recruitment spanned from 2017 to 2019. 30 subjects in total were screened, while 16 of those subjects enrolled in the study. All subjects were recruited through the Mass General Brigham Clinical Trials Portal or through referrals via our internal McLean "Successful Aging through Group Engagement" program.
Enrolled subjects underwent thorough screening procedures to determine diagnostic status. Two subjects did not meet diagnostic criteria and thus were not assigned to a group. One subject withdrew from the study due to personal reasons before being assigned to a group.
Participant milestones
| Measure |
Cross-Over Phase; Active LFMS First
Active Low Field Magnetic Stimulation before Sham Low Field Magnetic Stimulation
Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
Cross-Over Phase; Sham LFMS First
Sham Low Field Magnetic Stimulation before Active Low Field Magnetic Stimulation
Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
Parallel Phase; Active LFMS
Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
|
Parallel Phase; Sham LFMS
Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
5
|
3
|
2
|
|
Overall Study
COMPLETED
|
3
|
5
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LFMS: Initial Trial in Geriatric Bipolar Depression
Baseline characteristics by cohort
| Measure |
Phase 1: Cross-Over, Active LFMS First
n=3 Participants
Active Low Field Magnetic Stimulation before Sham Low Field Magnetic Stimulation
Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
Phase 1: Cross-Over, Sham LFMS First
n=5 Participants
Sham Low Field Magnetic Stimulation before Active Low Field Magnetic Stimulation
Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
Phase 2: Parallel, Active LFMS
n=3 Participants
Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
|
Phase 2: Parallel, Sham LFMS
n=2 Participants
Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.0 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
66.4 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
71.5 years
STANDARD_DEVIATION 2.1 • n=4 Participants
|
64.8 years
STANDARD_DEVIATION 6.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
MADRS Baseline
|
30.3 scores on a scale
STANDARD_DEVIATION 7.02 • n=5 Participants
|
25.4 scores on a scale
STANDARD_DEVIATION 4.10 • n=7 Participants
|
27.33 scores on a scale
STANDARD_DEVIATION 11.93 • n=5 Participants
|
22.5 scores on a scale
STANDARD_DEVIATION 3.54 • n=4 Participants
|
26.53 scores on a scale
STANDARD_DEVIATION 6.75 • n=21 Participants
|
|
HARS Hamilton Anxiety Rating Scale
|
17.67 scores on a scale
STANDARD_DEVIATION 7.77 • n=5 Participants
|
12.4 scores on a scale
STANDARD_DEVIATION 5.77 • n=7 Participants
|
15.67 scores on a scale
STANDARD_DEVIATION 4.93 • n=5 Participants
|
13 scores on a scale
STANDARD_DEVIATION 4.24 • n=4 Participants
|
14.46 scores on a scale
STANDARD_DEVIATION 5.64 • n=21 Participants
|
|
PANAS: Positive and Negative Affect Scale, Positive Subscale
|
20.33 score on a scale
STANDARD_DEVIATION 3.79 • n=5 Participants
|
22.4 score on a scale
STANDARD_DEVIATION 11.28 • n=7 Participants
|
25 score on a scale
STANDARD_DEVIATION 8.89 • n=5 Participants
|
23.5 score on a scale
STANDARD_DEVIATION 9.19 • n=4 Participants
|
22.69 score on a scale
STANDARD_DEVIATION 8.24 • n=21 Participants
|
PRIMARY outcome
Timeframe: Phase 1 cross-over: scores at base visit 1 (week 0), visit 5 (week 2), and visit 9 (week 4). Differences are between visits 5-1 and 9-5. Phase 2 parallel: scores at base visit 1 (day 0) and visit 7 (day 10). Differences are between visits 7-1.The Montgomery-Asberg Depression Rating Scale (MADRS) is a diagnostic assessment measuring the severity of depressive symptoms. It is a 10-item scale assessing all core symptoms of repression. Each item is scored on a 7-point scale, ranging from 0 (symptom not present) to 6 (symptom severely present). Thus, the total score range is 0-60, with higher scores indicating more depressive symptom endorsement.
Outcome measures
| Measure |
Phase 1: Cross-Over, Active LFMS First
n=3 Participants
Active Low Field Magnetic Stimulation
Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
Phase 1: Cross-Over, Sham LFMS First
n=5 Participants
Sham Low Field Magnetic Stimulation
Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
Phase 2: Parallel, Active LFMS
n=3 Participants
Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
|
Phase 2: Parallel, Sham LFMS
n=2 Participants
Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
|---|---|---|---|---|
|
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Sham LFMS
|
4.67 score on scale
Standard Deviation 5.86
|
-7.2 score on scale
Standard Deviation 8.02
|
NA score on scale
Standard Deviation NA
The Parallel Phase subjects were assigned to either active or sham LFMS groups, so they have no data to report in the rows which they did not participate in.
|
-2.50 score on scale
Standard Deviation 2.12
|
|
Change in Montgomery Asberg Depression Rating Scale (MADRS)
Active LFMS
|
-13 score on scale
Standard Deviation 10.44
|
2.4 score on scale
Standard Deviation 14.15
|
-7.67 score on scale
Standard Deviation 4.51
|
NA score on scale
Standard Deviation NA
The Parallel Phase subjects were assigned to either active or sham LFMS groups, so they have no data to report in the rows which they did not participate in.
|
PRIMARY outcome
Timeframe: Phase 1 cross-over: scores at base visit 1 (week 0), visit 5 (week 2), and visit 9 (week 4). Differences are between visits 5-1 and 9-5. Phase 2 parallel: scores at base visit 1 (day 0) and visit 7 (day 10). Differences are between visits 7-1.The Hamilton Anxiety Rating Scale (HARS) assesses the severity of anxiety symptoms. It is a 14-item scale covering psychic and somatic anxiety. Each item is scored on a 5-point scale, ranging from 0 (not present) to 4 (severe). Thus, the total score range is 0-56, wither higher scores indicating higher anxiety severity.
Outcome measures
| Measure |
Phase 1: Cross-Over, Active LFMS First
n=3 Participants
Active Low Field Magnetic Stimulation
Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
Phase 1: Cross-Over, Sham LFMS First
n=5 Participants
Sham Low Field Magnetic Stimulation
Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
Phase 2: Parallel, Active LFMS
n=3 Participants
Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
|
Phase 2: Parallel, Sham LFMS
n=2 Participants
Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
|---|---|---|---|---|
|
Change in Hamilton Anxiety Rating Scale (HARS)
Active
|
-7.67 score on a scale
Standard Deviation 10.69
|
4.2 score on a scale
Standard Deviation 9.58
|
15.67 score on a scale
Standard Deviation 4.93
|
NA score on a scale
Standard Deviation NA
The Parallel Phase subjects were assigned to either active or sham LFMS groups, so they have no data to report in the rows which they did not participate in.
|
|
Change in Hamilton Anxiety Rating Scale (HARS)
Sham
|
3 score on a scale
Standard Deviation 5.20
|
-5.4 score on a scale
Standard Deviation 5.32
|
NA score on a scale
Standard Deviation NA
The Parallel Phase subjects were assigned to either active or sham LFMS groups, so they have no data to report in the rows which they did not participate in.
|
-7.33 score on a scale
Standard Deviation 3.214
|
PRIMARY outcome
Timeframe: Phase 1 cross-over: scores at base visit 1 (week 0), visit 5 (week 2), and visit 9 (week 4). Differences are between visits 5-1 and 9-5. Phase 2 parallel: scores at base visit 1 (day 0) and visit 7 (day 10). Differences are between visits 7-1.The Positive and Negative Affect Schedule (PANAS) assesses the presence and severity of two factors: positive affect (PA), which indicates the extent that a person is experiencing high energy, enthusiastic, mood state, and negative affect (NA), which indicates the extent a person is experiencing an aversive mood state. The PANAS is a 20-item scale, with 10 items measured PA and 10 items measuring NA. Each item is scored on a 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Thus, the score range for PA is 10-50, and the score range for NA is 10-50, with higher scores indicated more endorsement of PA (more energy, concentration, and pleasure) or NA (more anger, disgust, contempt). This study reports data on the score ranges for the PA sub-scale.
Outcome measures
| Measure |
Phase 1: Cross-Over, Active LFMS First
n=3 Participants
Active Low Field Magnetic Stimulation
Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
Phase 1: Cross-Over, Sham LFMS First
n=5 Participants
Sham Low Field Magnetic Stimulation
Phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Then repeat with three 20 minute treatments of sham LFMS, once per day for three consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
Phase 2: Parallel, Active LFMS
n=3 Participants
Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
|
Phase 2: Parallel, Sham LFMS
n=2 Participants
Phase 2 parallel: five 20 minute treatments, once per day for five consecutive days
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
|---|---|---|---|---|
|
Change in Positive and Negative Affect Schedule (PANAS), Positive Sub Scale
Active LFMS
|
-3 score on a scale
Standard Deviation 7.2
|
1.2 score on a scale
Standard Deviation 15.5
|
-4.33 score on a scale
Standard Deviation 4.16
|
NA score on a scale
Standard Deviation NA
The Parallel Phase subjects were assigned to either active or sham LFMS groups, so they have no data to report in the rows which they did not participate in.
|
|
Change in Positive and Negative Affect Schedule (PANAS), Positive Sub Scale
Sham LFMS
|
4 score on a scale
Standard Deviation 12.17
|
-0.4 score on a scale
Standard Deviation 2.45
|
NA score on a scale
Standard Deviation NA
The Parallel Phase subjects were assigned to either active or sham LFMS groups, so they have no data to report in the rows which they did not participate in.
|
-4 score on a scale
Standard Deviation 2.83
|
Adverse Events
Active LFMS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sham LFMS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active LFMS
n=6 participants at risk
Includes subjects in phase 1 crossover: three 20 minute treatments of active LFMS, once per day for three consecutive days. Also includes subjects in parallel phase: five 20 minute treatments, once per day for five consecutive days.
Active Low Field Magnetic Stimulation: Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
|
Sham LFMS
n=7 participants at risk
Includes subjects in phase 1 crossover: three 20 minute treatments of sham LFMS, once per day for three consecutive days. Also includes subjects in parallel phase: five 20 minute treatments, once per day for five consecutive days
Sham Low Field Magnetic Stimulation: The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
|
|---|---|---|
|
Nervous system disorders
headache
|
33.3%
2/6 • Number of events 2 • Participants in the cross-over phase were assessed over the course of 5 weeks, with the screen procedures occurring in week 1, active/sham treatments occurring in week 2, a follow-up in week 3, active/sham treatments occurring in week 4, and a follow-up in week 5. Participants in the parallel phase were assessed over the course of 4 weeks, with screening/baseline in week 1, five consecutive treatments in week 2, and one follow-up call per week for weeks 3 and 4.
Definition of adverse event and/or serious adverse event was the same as the definition used by this website. Adverse events were queried for during every research visit.
|
14.3%
1/7 • Number of events 1 • Participants in the cross-over phase were assessed over the course of 5 weeks, with the screen procedures occurring in week 1, active/sham treatments occurring in week 2, a follow-up in week 3, active/sham treatments occurring in week 4, and a follow-up in week 5. Participants in the parallel phase were assessed over the course of 4 weeks, with screening/baseline in week 1, five consecutive treatments in week 2, and one follow-up call per week for weeks 3 and 4.
Definition of adverse event and/or serious adverse event was the same as the definition used by this website. Adverse events were queried for during every research visit.
|
|
Ear and labyrinth disorders
Dizziness
|
0.00%
0/6 • Participants in the cross-over phase were assessed over the course of 5 weeks, with the screen procedures occurring in week 1, active/sham treatments occurring in week 2, a follow-up in week 3, active/sham treatments occurring in week 4, and a follow-up in week 5. Participants in the parallel phase were assessed over the course of 4 weeks, with screening/baseline in week 1, five consecutive treatments in week 2, and one follow-up call per week for weeks 3 and 4.
Definition of adverse event and/or serious adverse event was the same as the definition used by this website. Adverse events were queried for during every research visit.
|
14.3%
1/7 • Number of events 1 • Participants in the cross-over phase were assessed over the course of 5 weeks, with the screen procedures occurring in week 1, active/sham treatments occurring in week 2, a follow-up in week 3, active/sham treatments occurring in week 4, and a follow-up in week 5. Participants in the parallel phase were assessed over the course of 4 weeks, with screening/baseline in week 1, five consecutive treatments in week 2, and one follow-up call per week for weeks 3 and 4.
Definition of adverse event and/or serious adverse event was the same as the definition used by this website. Adverse events were queried for during every research visit.
|
|
Nervous system disorders
Pressure in Head
|
0.00%
0/6 • Participants in the cross-over phase were assessed over the course of 5 weeks, with the screen procedures occurring in week 1, active/sham treatments occurring in week 2, a follow-up in week 3, active/sham treatments occurring in week 4, and a follow-up in week 5. Participants in the parallel phase were assessed over the course of 4 weeks, with screening/baseline in week 1, five consecutive treatments in week 2, and one follow-up call per week for weeks 3 and 4.
Definition of adverse event and/or serious adverse event was the same as the definition used by this website. Adverse events were queried for during every research visit.
|
14.3%
1/7 • Number of events 1 • Participants in the cross-over phase were assessed over the course of 5 weeks, with the screen procedures occurring in week 1, active/sham treatments occurring in week 2, a follow-up in week 3, active/sham treatments occurring in week 4, and a follow-up in week 5. Participants in the parallel phase were assessed over the course of 4 weeks, with screening/baseline in week 1, five consecutive treatments in week 2, and one follow-up call per week for weeks 3 and 4.
Definition of adverse event and/or serious adverse event was the same as the definition used by this website. Adverse events were queried for during every research visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place