Trial Outcomes & Findings for Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome (NCT NCT02470377)
NCT ID: NCT02470377
Last Updated: 2022-08-31
Results Overview
The Dizziness Handicap Inventory is a widely used measure of subjective dizziness in which 25 questions of dizziness inducing events are rated on a scale of 0-2-4. The maximum number of points is 100 points which are divided into the following levels: 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap).
COMPLETED
NA
24 participants
10 weeks (4 pre stimulation + 6 post stimulation)
2022-08-31
Participant Flow
August 15 to July 2017
All enrolled participants were included. This was an N-of-1 study so all participants received one session each of each target. Two participants were excluded prior to enrollment (one due to medical illness before she selected a target, one due to side effects from all targets and not being treated on the protocol).
Participant milestones
| Measure |
Occipital Transcranial Magnetic Stimulation
After determination of the motor threshold, the TMS coil will be positioned at predetermined locations over the brain using MRI guidance and a frameless stereotaxy system. A train of continuous theta burst mode will be delivered over the midline occipital cortex with MRI guided neuronavigation.
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
Cerebellar Vermis Transcranial Magnetic Stimulation
An active comparator not at the target of interest will be used for the study. A train of continuous theta burst mode will be delivered over the midline cerebellar vermis with MRI guided neuronavigation.
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
Cerebellar Hemisphere Control Transcranial Magnetic Stimulation
An active comparator not at the target of interest will be used for the study. A train of continuous theta burst mode will be delivered over the cerebellar hemisphere with MRI guided neuronavigation.
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
9
|
5
|
|
Overall Study
COMPLETED
|
10
|
9
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcranial Magnetic Stimulation for Mal de Debarquement Syndrome
Baseline characteristics by cohort
| Measure |
Target 1: Occipital Cortex
n=10 Participants
After determination of the motor threshold, the TMS coil will be positioned at predetermined locations over the brain using MRI guidance and a frameless stereotaxy system. A train of continuous theta burst mode will be delivered at the midline occipital cortex, with the brain locations determined by MRI and real-time neuronavigation.
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
Target 2: Cerebellar Vermis
n=9 Participants
An active comparator not at the target of interest will be used for the study. A train of continuous theta burst mode will be delivered at the midline cerebellar vermis, with the brain locations determined by MRI and real-time neuronavigation.
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
Target 3: Cerebellar Hemisphere
n=5 Participants
An active comparator not at the target of interest will be used for the study. A train of continuous theta burst mode will be delivered at the cerebellar hemisphere with the brain locations determined by MRI and real-time neuronavigation.
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.1 years
STANDARD_DEVIATION 11.1 • n=99 Participants
|
53.6 years
STANDARD_DEVIATION 11.5 • n=107 Participants
|
42.6 years
STANDARD_DEVIATION 14.0 • n=206 Participants
|
51.9 years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Dizziness Handicap Inventory Total
|
46.2 units on a scale
STANDARD_DEVIATION 13.7 • n=99 Participants
|
51.1 units on a scale
STANDARD_DEVIATION 13.0 • n=107 Participants
|
51.6 units on a scale
STANDARD_DEVIATION 12.6 • n=206 Participants
|
49.2 units on a scale
STANDARD_DEVIATION 12.9 • n=7 Participants
|
|
Mal de Debarquement Balance Rating Scale
|
4.6 units on a scale
STANDARD_DEVIATION 1.3 • n=99 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 0.8 • n=107 Participants
|
4.4 units on a scale
STANDARD_DEVIATION 1.5 • n=206 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 1.2 • n=7 Participants
|
|
Hospital Anxiety and Depression Scale-Anxiety
|
6.2 units on a scale
STANDARD_DEVIATION 2.6 • n=99 Participants
|
6.3 units on a scale
STANDARD_DEVIATION 3.8 • n=107 Participants
|
9.4 units on a scale
STANDARD_DEVIATION 3.2 • n=206 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 3.3 • n=7 Participants
|
|
Hospital Anxiety and Depression Scale-Depression
|
7.0 units on a scale
STANDARD_DEVIATION 3.4 • n=99 Participants
|
8.0 units on a scale
STANDARD_DEVIATION 3.2 • n=107 Participants
|
9.6 units on a scale
STANDARD_DEVIATION 3.8 • n=206 Participants
|
7.9 units on a scale
STANDARD_DEVIATION 3.4 • n=7 Participants
|
PRIMARY outcome
Timeframe: 10 weeks (4 pre stimulation + 6 post stimulation)Population: The median of the 4 pre-stimulation scores was used as the baseline. The difference between this number and the post-stimulation scores were calculated for each participant. The mean and standard deviation for the change in scores from the median of the baseline scores is presented for each treatment group for scores reported immediately after TMS and 6 weeks post TMS.
The Dizziness Handicap Inventory is a widely used measure of subjective dizziness in which 25 questions of dizziness inducing events are rated on a scale of 0-2-4. The maximum number of points is 100 points which are divided into the following levels: 16-34 Points (mild handicap), 36-52 Points (moderate handicap), 54+ Points (severe handicap).
Outcome measures
| Measure |
Occipital Transcranial Magnetic Stimulation
n=10 Participants
After determination of the motor threshold, the TMS coil will be positioned at predetermined locations over the brain using MRI guidance and a frameless stereotaxy system. A train of stimulation pulses (repetitive TMS) at 1Hz up to 10Hz or in theta burst mode will be delivered at one or more locations over the head, depending on the brain location under study (brain locations determined by MRI data).
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
Vermis Transcranial Magnetic Stimulation
n=9 Participants
An active comparator not at the target of interest will be used for the study.
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
Cerebellar Hemisphere Control Transcranial Magnetic Stimulation
n=5 Participants
An active comparator not at the target of interest will be used for the study.
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
|---|---|---|---|
|
Dizziness Handicap Inventory
Immediate change
|
-17.5 score on a scale
Standard Deviation 10.3
|
-3.7 score on a scale
Standard Deviation 10.6
|
-8.4 score on a scale
Standard Deviation 14.4
|
|
Dizziness Handicap Inventory
6 week change
|
-10.1 score on a scale
Standard Deviation 18.0
|
-9.7 score on a scale
Standard Deviation 12.2
|
-4.0 score on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: 10 weeks (4 pre stimulation + 6 post stimulation)Population: The median of the 4 pre-stimulation scores was used as the baseline. The difference between this number and the post-stimulation scores were calculated for each participant. The mean and standard deviation for the change in scores from the median of the baseline scores is presented for each treatment group for scores reported immediately after TMS and 6 weeks post TMS.
The MdDS Balance Rating Scale is a 10-point scale inquiring about the severity of rocking vertigo in which 1 means no rocking and 10 is so severe that standing is not possible. A level of 6 indicates that gait is impaired due to the severity of rocking.
Outcome measures
| Measure |
Occipital Transcranial Magnetic Stimulation
n=10 Participants
After determination of the motor threshold, the TMS coil will be positioned at predetermined locations over the brain using MRI guidance and a frameless stereotaxy system. A train of stimulation pulses (repetitive TMS) at 1Hz up to 10Hz or in theta burst mode will be delivered at one or more locations over the head, depending on the brain location under study (brain locations determined by MRI data).
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
Vermis Transcranial Magnetic Stimulation
n=9 Participants
An active comparator not at the target of interest will be used for the study.
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
Cerebellar Hemisphere Control Transcranial Magnetic Stimulation
n=5 Participants
An active comparator not at the target of interest will be used for the study.
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
|---|---|---|---|
|
Mal de Debarquement Balance Rating Scale
Immediate change
|
-1.8 score on a scale
Standard Deviation 1.3
|
-1.3 score on a scale
Standard Deviation 0.9
|
-0.1 score on a scale
Standard Deviation 0.5
|
|
Mal de Debarquement Balance Rating Scale
6 week change
|
-1.1 score on a scale
Standard Deviation 1.7
|
-1.3 score on a scale
Standard Deviation 1.6
|
-0.1 score on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 10 weeks (4 pre stimulation + 6 post stimulation)Population: The median of the 4 pre-stimulation scores was used as the baseline. The difference between this number and the post-stimulation scores were calculated for each participant. The mean and standard deviation for the change in scores from the median of the baseline scores is presented for each treatment group for scores reported immediately after TMS and 6 weeks post TMS.
The Hospital Anxiety and Depression Scale is a widely used scale that inquires about anxiety and depression symptoms with 14 questions divided into 7 questions about anxiety and 7 questions about depression. Each item is rated from 0-3 per item yielding a maximum of 21 points per item. Each subscale is rated as follows: 0-7 (Normal), 8-10 (Borderline), 11-21 (Abnormal).
Outcome measures
| Measure |
Occipital Transcranial Magnetic Stimulation
n=10 Participants
After determination of the motor threshold, the TMS coil will be positioned at predetermined locations over the brain using MRI guidance and a frameless stereotaxy system. A train of stimulation pulses (repetitive TMS) at 1Hz up to 10Hz or in theta burst mode will be delivered at one or more locations over the head, depending on the brain location under study (brain locations determined by MRI data).
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
Vermis Transcranial Magnetic Stimulation
n=9 Participants
An active comparator not at the target of interest will be used for the study.
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
Cerebellar Hemisphere Control Transcranial Magnetic Stimulation
n=5 Participants
An active comparator not at the target of interest will be used for the study.
Transcranial Magnetic Stimulation: A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
|
|---|---|---|---|
|
Hospital Anxiety and Depression Scale
Immediate change-Anxiety
|
-2.5 score on a scale
Standard Deviation 2.4
|
0.8 score on a scale
Standard Deviation 5.3
|
-0.2 score on a scale
Standard Deviation 2.6
|
|
Hospital Anxiety and Depression Scale
6 week change-Anxiety
|
-2.2 score on a scale
Standard Deviation 2.4
|
-1.6 score on a scale
Standard Deviation 3.5
|
-0.4 score on a scale
Standard Deviation 1.9
|
|
Hospital Anxiety and Depression Scale
Immediate change-Depression
|
-2.4 score on a scale
Standard Deviation 2.5
|
-0.4 score on a scale
Standard Deviation 4.9
|
1.4 score on a scale
Standard Deviation 2.5
|
|
Hospital Anxiety and Depression Scale
6 week change-Depression
|
-1.7 score on a scale
Standard Deviation 4.3
|
-1.4 score on a scale
Standard Deviation 3.7
|
0.4 score on a scale
Standard Deviation 1.0
|
Adverse Events
Target 1 Transcranial Magnetic Stimulation
Target 2 Transcranial Magnetic Stimulation
Target 3 Control Site Transcranial Magnetic Stimulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place