CompletedNCT02452892Updated Dec 5, 2017Results posted

Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)

An interventional study of LFMS in Depression, Depressive Disorder and Depressive Disorder, Treatment-resistant, sponsored by Tal Medical, Inc.. Completed at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-05.

Sponsored by Tal Medical, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 122
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to compare the relative effectiveness of 20 and 60 minutes of Low-Field Magnetic Stimulation in relieving symptoms in patients with major depression who are treatment resistant.

Read the detailed description

The primary objective of this study:

To compare the relative efficacy, as measured by a change in the 6-item Hamilton Rating Scale for Depression (HAM-D6), of 20 and 60 minutes of LFMS compared to sham (placebo) in subjects with treatment resistant depression (TRD).

Secondary objectives:

To determine if subjects with TRD may respond to 120 minutes of LFMS.
To determine the persistence of response to LFMS therapy during the observation period.
To evaluate the safety and tolerability of LFMS.

Conditions studied

Depression
Depressive Disorder
Depressive Disorder, Treatment-resistant
Depressive Disorder, Major

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Keywords

Depression
Major depression
Low-field magnetic stimulation
LFMS

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 122 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

This is the only study on the registry with Tal Medical, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria: (Key)

Meets the Diagnostic and Statistical Manual of Mental Disorder, 5th Edition (DSM-5) criteria for Major Depressive Disorder (MDD), as determined by psychiatric evaluation.
Has TRD of the current MDE, as assessed at the site by the Massachusetts General Hospital/Antidepressant Treatment Response Questionnaire (MGH/ATRQ).
On an adequate dose of one antidepressant therapy (ADT) for at least eight weeks prior to the screening visit (Visit 1). The ADT dose must be stable for at least four weeks prior to the screening visit (Visit 1). Subjects must be willing to remain on the same stable dose of ADT upon signing the informed consent form until the end of the treatment observation period (end of Week 2) and, where possible, to the end of study participation

Exclusion Criteria: (Key)

Have failed four or more lifetime adequate ADT treatment regimens (including the ongoing ADT for the current MDE).
Have been treated with adjunctive antipsychotic medication with an antidepressant for at least two weeks during the current depressive episode.
Are deemed to be at significant risk for suicidal behavior
Are unable to lie on their back for the duration of study treatment
Have a lifetime history of:
1. Delirium, dementia, amnestic, or other cognitive disorder;
2. Schizophrenia or any psychotic disorder, based on the Structured Clinical Interview for DSM-5 Axis I Disorders Patient Edition (SCID-I/P);
3. Bipolar I or II disorder, based on the SCID-I/P.
Have a current DSM-5 diagnosis at the screening visit (Visit 1) of:
1. An eating disorder active within the 12 months prior to the screening visit (Visit 1);
2. Comorbid anxiety disorders that predominate over MDD, as assessed by the investigator;
3. Alcohol or substance use disorder active within the 12 months prior to the screening visit (Visit 1);
4. Clinically significant DSM-5 Axis II disorder.
Have ever received electroconvulsive therapy, vagal nerve stimulation, deep brain stimulation or repetitive transcranial magnetic stimulation.
Have a non-removable programmable device or appliance such as cardiac pacemakers or cochlear implants.
Have any non-removable ferromagnetic implants, or conductive or other magnetic sensitive materials present in the head or neck .
Have a lifetime history of seizures or clinically significant electroencephalography abnormalities. A history of childhood febrile seizures is permitted.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 122 participants (actual)

Study arms

Sham comparator
LFMS Sham
For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered. Low field magnetic stimulation (no magnetic field for sham) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Device: LFMS
Active comparator
LFMS 20 minutes
LFMS 20 minutes + Sham 40 min.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Device: LFMS
Active comparator
LFMS 60 minutes
LFMS 60 minutes.Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Device: LFMS
Other
LFMS 120 min
Week 2 subjects may be re-randomized to receive LFMS 120 minutes. Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS.
Device: LFMS

Interventions

DeviceLFMS
Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
Also known as: Low Field Magnetic Stimulation

What researchers measure

Primary outcomes

Change From Baseline to ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score.
Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 1 Day 4 minus mean score at baseline". Week 1 Day 4 : Change from baseline to the end of the efficacy period ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) total score .Responders at Day 4 will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders at Day 4. Each patient's total score is his/her own reference for determining a decrease of 50% or more.
Time frame: Week 1 Day 4

Secondary outcomes

Change From Day 4 in HAM-D6 Total Score at Day 11 for Week 1 Non-responders: Response to 120 Minutes LFMS
Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from Day 11: mean score at Week 2 Day 11 minus mean score at Day 4". To determine if subjects with TRD who are non-responders to 0, 20 or 60 minutes of LFMS on Day 4 may respond to 120 minutes of LFMS at the end of Day 11. Responders will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders. Each patient's total score is his/her own reference for determining a decrease of 50% or more.
Time frame: Day 11 (Week 2)
Day 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score
To determine the persistence of response to LFMS therapy during a four-week follow-up period in subjects who were responders at Day 4. Persistence of response was achieved if during Week 2 post baseline visits and follow-up visits subjects' 6-item Hamilton Rating Scale for Depression (HAM-D6) total scores were lower than or equal to 50% of the baseline ( Day1 Week1) scores. Non-responder imputation method was used where missing post-baseline dichotomous ("yes or no") were imputed as non-responder. Logistic regression model used to compare treatment groups for each visit, where the model considers the treatment, age and gender as covariates.
Time frame: Day 42

Results

Posted Dec 5, 2017

Limitations and caveats

The study was not powered for secondary measures. Statistical significance for group-wise comparisons wasn't expected.

Participant flow

12clinical study sites in the US recruited 122 subjects that were randomized into the study. The date of first subject enrollment was 03 September 2015 and the date of last subject enrolled was 22 July 2016.

Week 1 Initial Randommization

Participant flow — Week 1 Initial Randommization
Milestone	LFMS Sham	LFMS 20 Minutes	LFMS 60 Minutes
Started	41	40	41
Completed	40	40	40
Not completed	1	0	1
Withdrew: Adverse event	1	0	0
Withdrew: Lost to follow-up	0	0	1

Week 2 Stratification & Re-Randomization

Participant flow — Week 2 Stratification & Re-Randomization
Milestone	LFMS Sham	LFMS 20 Minutes	LFMS 60 Minutes	LFMS 120 Min
Started	65	7	7	41
Non-reponders	38	0	0	41
Responders	27	7	7	0
Completed	63	7	7	39
Not completed	2	0	0	2
Withdrew: Withdrawal by subject	0	0	0	2
Withdrew: Lost to follow-up	2	0	0	0

Follow-up

Participant flow — Follow-up
Milestone	LFMS Sham	LFMS 20 Minutes	LFMS 60 Minutes	LFMS 120 Min
Started	63	7	7	39
Completed	62	7	7	38
Not completed	1	0	0	1
Withdrew: Withdrawal by subject	0	0	0	1
Withdrew: Subject left town on day 42	1	0	0	0

Outcome measures

PrimaryChange From Baseline to ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score.

Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from baseline: mean score at Week 1 Day 4 minus mean score at baseline". Week 1 Day 4 : Change from baseline to the end of the efficacy period ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) total score .Responders at Day 4 will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders at Day 4. Each patient's total score is his/her own reference for determining a decrease of 50% or more.

Time frame:: Week 1 Day 4
Reported as:: Least squares mean · units on a scale

Change From Baseline to ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score.
units on a scale	LFMS Sham	LFMS 20 Minutes	LFMS 60 Minutes
Change From Baseline to ( Day 4) in the 6-item Hamilton Rating Scale for Depression (HAM-D6) Total Score.	-4.0 (-5.18 to -2.91)	-4.2 (-5.34 to -3.04)	-4.9 (-6.03 to -3.73)

Statistical analysis

LFMS Sham vs LFMS 60 Minutes · Mixed Models Analysis · p = 0.307 (P-value displayed for 60min. Mixed Model Repeated Measures (MMRM) model.)Week 1 baseline HAM-D6 total score, treatment,visit treatment\*visit age, \& gender included in model. Visit was the repeated measure within subjects.
LFMS Sham vs LFMS 20 Minutes · Mixed Models Analysis · p = 0.859 (P-value displayed for 20min. Mixed Model Repeated Measures (MMRM) model.)Week 1 baseline HAM-D6 total score, treatment,visit treatment\*visit age, \& gender included in model. Visit was the repeated measure within subjects.

SecondaryChange From Day 4 in HAM-D6 Total Score at Day 11 for Week 1 Non-responders: Response to 120 Minutes LFMS

Hamilton Rating Scales for Depression were designed to measure the severity of depressive symptoms in subjects with primary depressive illness. HAM-D6 is a subset of the HAM-D17 that assesses 6 items associated with major depression. The scale uses HAM-D17 items 1, 2, 7, 8, 10 and 13. Item 13 is scored 0 to 2 and all others are scored 0 to 4. Total score ranges from 0 to 22; higher score indicates more depression. Change from Day 11: mean score at Week 2 Day 11 minus mean score at Day 4". To determine if subjects with TRD who are non-responders to 0, 20 or 60 minutes of LFMS on Day 4 may respond to 120 minutes of LFMS at the end of Day 11. Responders will be defined as those subjects who achieve a decrease in HAM-D6 total score of 50% or more compared to baseline (Day 1, Week 1). All other subjects will be deemed to be non-responders. Each patient's total score is his/her own reference for determining a decrease of 50% or more.

Time frame:: Day 11 (Week 2)
Reported as:: Least squares mean · units on a scale

Change From Day 4 in HAM-D6 Total Score at Day 11 for Week 1 Non-responders: Response to 120 Minutes LFMS
units on a scale	LFMS Sham	LFMS 120 Min
Change From Day 4 in HAM-D6 Total Score at Day 11 for Week 1 Non-responders: Response to 120 Minutes LFMS	-2.6 (-3.60 to -1.68)	-2.6 (-3.56 to -1.67)

Statistical analysis

LFMS Sham vs LFMS 120 Min · Mixed Models Analysis · p = 0.966 (P-value is not adjusted for multiple comparisons. P-value was estimated from Mixed Model Repeated Measures (MMRM) model.)Week 2 baseline HAM-D6 total score, treatment, visit, treatment\*visit, age, \& gender included in model. Visit was the repeated measure within subject.

SecondaryDay 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score

To determine the persistence of response to LFMS therapy during a four-week follow-up period in subjects who were responders at Day 4. Persistence of response was achieved if during Week 2 post baseline visits and follow-up visits subjects' 6-item Hamilton Rating Scale for Depression (HAM-D6) total scores were lower than or equal to 50% of the baseline ( Day1 Week1) scores. Non-responder imputation method was used where missing post-baseline dichotomous ("yes or no") were imputed as non-responder. Logistic regression model used to compare treatment groups for each visit, where the model considers the treatment, age and gender as covariates.

Time frame:: Day 42
Reported as:: Number · percentage of LFMS responders

Day 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score
percentage of LFMS responders	LFMS 20 Minutes	LFMS 60 Minutes	LFMS Sham
Day 4 Responders: Persistence of Effect Based on Pre-specified HAM-D6 Total Score	53.8	57.1	78.6

Statistical analysis

LFMS 60 Minutes vs LFMS Sham · Regression, Logistic · p = 0.294 (For 60 min LFMS, P-value not adjusted for multiple comparisons. P-value estimated using LR model including Wk2 baseline HAM-D6 total score, treatment, age \& gender as covariates.)Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response
LFMS 20 Minutes vs LFMS Sham · Regression, Logistic · p = 0.232 (For 20min. LFMS, P-value not adjusted for multiple comparisons. P-value estimated using Logistic Regression model including Wk2 baseline HAM-D6 total score, treatment, age \& gender as covariates.)Non-responder imputation (NRI) for missing data, where missing post-baseline results were considered non-response

Post-hocMontgomery-Asberg Depression Rating Scale (MADRS): Change From Week 1 Baseline (Day 1) to End of Week 1 (Day 4)

The MADRS is a 10-item checklist designed to measure the overall severity of depressive symptoms in subjects with Major Depressive Disorder (MDD). Individual items are rated on a scale of 0 to 6 in which a score of 6 represents the most severe symptoms for each item assessed. The total score ranges from 0 to 60. Remission of depression based on the MADRS is defined as a subject with a MADRS total score of ≤11 at endpoint. A responder on the MADRS is defined as a 50% or greater reduction from baseline in total MADRS score

Time frame:: Day 4 Week 1
Reported as:: Least squares mean · units on a scale

Montgomery-Asberg Depression Rating Scale (MADRS): Change From Week 1 Baseline (Day 1) to End of Week 1 (Day 4)
units on a scale	LFMS Sham	LFMS 20 Minutes	LFMS 60 Minutes
Montgomery-Asberg Depression Rating Scale (MADRS): Change From Week 1 Baseline (Day 1) to End of Week 1 (Day 4)	-7.58 (-9.8 to -5.4)	-8.09 (-10.3 to -5.8)	-10.32 (-12.6 to -8.0)

Statistical analysis

LFMS Sham vs LFMS 60 Minutes · ANCOVA · p = 0.0932 (P-value is not adjusted for multiple comparisons.)P-value was estimated using ANCOVA model with treatment, age, \& gender as factors and baseline negative MADRS score as a covariate.
LFMS Sham vs LFMS 20 Minutes · ANCOVA · p = 0.7509 (The p-value is not adjusted for multiple comparisons.)P-value was estimated using ANCOVA model with treatment, age, \& gender as factors and baseline negative MADRS score as a covariate.

Post-hocPositive and Negative Affect Schedule (PANAS): Change From Baseline at Day 4 in Positive Score

The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Used as a psychometric scale, the PANAS can show relationships between positive and negative affect with personality stats and traits. Descriptors are used to define their meanings. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).To calculate the positive affect score, added scores on items 1, 3, 5, 9, 10, 12, 14, 16, 17, and 19. Scores can range from 10-50, which higher scores representing higher levels of positive affect, or the extent to which the individual feels enthusiastic, active and alert.

Time frame:: Day 4 Week 1
Reported as:: Least squares mean · units on a scale

Positive and Negative Affect Schedule (PANAS): Change From Baseline at Day 4 in Positive Score
units on a scale	LFMS Sham	LFMS 20 Minutes	LFMS 60 Minutes
Positive and Negative Affect Schedule (PANAS): Change From Baseline at Day 4 in Positive Score	1.67 (-0.29 to 3.62)	3.62 (1.63 to 5.62)	3.24 (1.23 to 5.26)

Statistical analysis

LFMS Sham vs LFMS 60 Minutes · ANCOVA · p = 0.2672 (P-value not adjusted for multiple comparisons.)P-value estimated using ANCOVA model with treatment,age,\& gender as factors \& baseline positive PANAS score as a covariate.
LFMS Sham vs LFMS 20 Minutes · ANCOVA · p = 0.1660 (P-value not adjusted for multiple comparisons.)P-value estimated using ANCOVA model with treatment,age,\& gender as factors \& baseline positive PANAS score as a covariate.

Post-hocPositive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4

The PANAS comprises two mood scales, one that measures positive affect and the other that measures negative affect. Subjects completing the PANAS are required to respond to a 20-item test using 5-point scale that ranges from very slightly or not at all (1) to extremely (5).Negative affect scores can be obtained by adding up scores for items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20. The negative affect score can range from 10 to 50, with lower scores representing lower level of negative affect, or the extent to which the individual feels aversive mood states and general distress. This analysis outcome treated Item #2 as random missing data.

Time frame:: Day 4, Week 1
Reported as:: Least squares mean · units on a scale

Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4
units on a scale	LFMS Sham	LFMS 20 Minutes	LFMS 60 Minutes
Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4	-2.27 (-4.20 to -0.34)	-3.57 (-5.55 to -1.59)	-5.32 (-7.31 to -3.33)

Statistical analysis

LFMS Sham vs LFMS 60 Minutes · ANCOVA · p = 0.0307 (P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data.)P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.
LFMS Sham vs LFMS 20 Minutes · ANCOVA · p = 0.3537 (P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were considered as random missing data. .)P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.

Post-hocPositive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4

Time frame:: Day 4
Reported as:: Least squares mean · units on a scale

Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4
units on a scale	LFMS Sham	LFMS 20 Minutes	LFMS 60 Minutes
Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at Day 4	-2.95 (-5.03 to -0.87)	-3.78 (-5.94 to -1.59)	-5.58 (-7.74 to -3.41)

Statistical analysis

LFMS Sham vs LFMS 60 Minutes · ANCOVA · p = 0.0848 (P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was removed.)P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.
LFMS Sham vs LFMS 20 Minutes · ANCOVA · p = 0.5930 (P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where Incorrect Item #2 data was removed.)P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.

Post-hocPositive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at End of Week 1, Day 4

Time frame:: Day 4, Week 1
Reported as:: Least squares mean · units on a scale

Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at End of Week 1, Day 4
units on a scale	LFMS Sham	LFMS 20 Minutes	LFMS 60 Minutes
Positive and Negative Affect Schedule (PANAS) Change From Baseline in Negative Score at End of Week 1, Day 4	-2.29 (-4.24 to -0.34)	-3.50 (-5.49 to -1.51)	-5.36 (-7.36 to -3.36)

Statistical analysis

LFMS Sham vs LFMS 60 Minutes · ANCOVA · p = 0.0307 (P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.)P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.
LFMS Sham vs LFMS 20 Minutes · ANCOVA · p = 0.3907 (P-value not adjusted for multiple comparisons. All missing values including the 72 data points in Item#2 were treated where incorrect Item #2 data was imputed using worst possible value.)P-value estimated using ANCOVA model with treatment, age, \& gender as factors \& baseline negative PANAS score as a covariate.

Adverse events

Collected over Day 1- Day 42. Treatment-emergent events for Week 1 was defined as any Adverse Event (AE) that began on or after Day 1 treatment until the end of Day 7. Treatment-emergent AEs for Week 2 was defined as any AE that began on or after the Day 8 treatment until the end of Day 15 (not including the follow-up phase).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
LFMS Sham	0/79 (0%)	0/79 (0%)	20/79 (25.3%)
LFMS 20 Minutes	0/40 (0%)	0/40 (0%)	14/40 (35%)
LFMS 60 Minutes	0/41 (0%)	0/41 (0%)	13/41 (31.7%)
LFMS 120 Min - Week 2	0/41 (0%)	0/41 (0%)	10/41 (24.4%)

Most frequent other events

Showing 10 of 42

Most frequent other events
Event	LFMS Sham	LFMS 20 Minutes	LFMS 60 Minutes	LFMS 120 Min - Week 2
HeadcheNervous system disorders	7/79	6/40	4/41	4/41
DizzinessNervous system disorders	1/79	1/40	3/41	1/41
FatigueGeneral disorders	1/79	2/40	1/41	1/41
InsomniaPsychiatric disorders	2/79	0/40	2/41	1/41
DiarrhoeaGastrointestinal disorders	3/79	0/40	0/41	0/41
PyrexiaGeneral disorders	2/79	0/40	0/41	0/41
NasopharyngitisInfections and infestations	2/79	0/40	0/41	0/41
SomnolenceNervous system disorders	0/79	1/40	0/41	0/41
NauseaGastrointestinal disorders	1/79	1/40	1/41	0/41
Ligament sprainInjury, poisoning and procedural complications	0/79	1/40	0/41	0/41

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	LFMS Sham	LFMS 20 Minutes	LFMS 60 Minutes	Total
<=18 years	0	0	0	0
Between 18 and 65 years	37	35	37	109
>=65 years	4	5	4	13

Sex: Female, Male
Sex: Female, Male(Participants)	LFMS Sham	LFMS 20 Minutes	LFMS 60 Minutes	LFMS 120 Min	Total
Female	23	23	26	0	72
Male	18	17	15	0	50

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	LFMS Sham	LFMS 20 Minutes	LFMS 60 Minutes	Total
White	31	28	27	86
Black or African American	9	9	11	29
Asian	1	3	2	6
Other	0	0	1	1

Study locations

12 sites

CNS Trials
Garden Grove, California 92845, United States
Synergy Escondido
Lemon Grove, California 91945, United States
Pacific Trials Partners
Oakland, California 94612, United States
Sarkis Clinical Trials
Gainesville, Florida 32607, United States
CNS Healthcare
Jacksonville, Florida 32256, United States
Segal Institute
Lauderhill, Florida 33319, United States
Institute for Advanced Medical Research
Alpharetta, Georgia 30005, United States
Radiant Research
Atlanta, Georgia 30328, United States
Neurobehavioral-Clinical Research
Canton, Ohio 44718, United States
Midwest Clinical
Dayton, Ohio 45417, United States
Future Search Trials
Dallas, Texas 75231, United States
Northwest Clinical Research Center
Bellevue, Washington 98007, United States

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02452892
Lead sponsor: Tal Medical, Inc.
Responsible party: Sponsor
First posted: May 25, 2015
Start date: Sep 2015
Primary completion: Sep 2016
Completion: Oct 2016
Results posted: Dec 5, 2017
Last update: Dec 5, 2017

Study contacts

Atul Pande, MD

study chair · Tal Medical

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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