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The goal of this study is to determine whether external neuromodulation using repetitive transcranial magnetic stimulation (rTMS) can reduce the perception of self-motion that is experienced by individuals with mal de debarquement syndrome (MdDS). Mal de debarquement is translated as the "sickness of disembarkment," and refers to the chronic feeling of rocking dizziness that occurs after exposure to passive motion. Treatment for MdDS is limited and morbidity is high. The goal of the study is to determine whether rTMS can suppress the rocking dizziness of MdDS.
Participants will maintain web-based diaries of their symptoms for two weeks prior to treatment with rTMS. Up to 20 treatments with rTMS with either anatomically or functionally determined targets will be administered. Post treatment diaries will continue for up to 12 weeks after rTMS administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Target 1: Occipital Cortex | Experimental | After determination of the motor threshold, the TMS coil will be positioned over the midline occipital cortex using MRI guidance and a frameless stereotaxy system. A train of stimulation pulses in continuous theta burst mode will be delivered. |
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| Target 2: Cerebellar Vermis | Experimental | After determination of the motor threshold, the TMS coil will be positioned over the midline cerebellar vermis using MRI guidance and a frameless stereotaxy system. A train of stimulation pulses in continuous theta burst mode will be delivered. |
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| Target 3: Cerebellar Hemisphere | Active Comparator | After determination of the motor threshold, the TMS coil will be positioned over the lateral cerebellar hemisphere using MRI guidance and a frameless stereotaxy system. A train of stimulation pulses in continuous theta burst mode will be delivered. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation | Device | A form of external neuromodulation using pulsatile magnetic fields on the surface of the head. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dizziness Handicap Inventory | 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). | 10 weeks (4 pre stimulation + 6 post stimulation) |
| Measure | Description | Time Frame |
|---|---|---|
| Mal de Debarquement Balance Rating Scale | 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. | 10 weeks (4 pre stimulation + 6 post stimulation) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoon-Hee Cha | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33746890 | Result | Cha YH, Ding L, Yuan H. Neuroimaging Markers of Mal de Debarquement Syndrome. Front Neurol. 2021 Mar 4;12:636224. doi: 10.3389/fneur.2021.636224. eCollection 2021. | |
| 31436631 | Result | Cha YH, Gleghorn D, Doudican B. Occipital and Cerebellar Theta Burst Stimulation for Mal De Debarquement Syndrome. Otol Neurotol. 2019 Oct;40(9):e928-e937. doi: 10.1097/MAO.0000000000002341. |
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Anonymized data may be shared with other researchers when there is sufficient recruitment to assure that no individual may be identified based on demographic or clinical characteristics.
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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).
August 15 to July 2017
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This was an N-of-1 study. The numbers in each treatment category reflect the target that the participant chose after receiving one session each of the three targets given in randomized order.
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| ID | Title | Description |
|---|---|---|
| BG000 | Target 1: Occipital Cortex | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dizziness Handicap Inventory | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks (4 pre stimulation + 6 post stimulation) |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Target 1 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 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yoon-Hee Cha | University of Minnesota | 612-301-2738 | ycha@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2015 | Mar 3, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C537840 | Mal de debarquement |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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This was an N-of-1 pilot study in which all participants received one session of each of 3 targets and chose which of the 3 led to the most acute reduction in intensity of rocking. The participants were treated with the target that they chose and then completed post stimulation diaries.
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| Hospital Anxiety and Depression Scale | 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). | 10 weeks (4 pre stimulation + 6 post stimulation) |
| 34670201 | Result | Chen Y, Cha YH, Gleghorn D, Doudican BC, Shou G, Ding L, Yuan H. Brain network effects by continuous theta burst stimulation in mal de debarquement syndrome: simultaneous EEG and fMRI study. J Neural Eng. 2021 Nov 30;18(6):10.1088/1741-2552/ac314b. doi: 10.1088/1741-2552/ac314b. |
| BG001 | Target 2: Cerebellar Vermis | 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. |
| BG002 | Target 3: Cerebellar Hemisphere | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Dizziness Handicap Inventory Total | 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). Results reported are the differences immediately and at 6 weeks post-stimulation from the mean of the baseline 4 weeks of pre-stimulation scores. | Mean | Standard Deviation | units on a scale |
|
| Mal de Debarquement Balance Rating Scale | 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. Results reported are the differences immediately and at 6 weeks post-stimulation from the mean of the baseline 4 weeks of pre-stimulation scores. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression Scale-Anxiety | 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). Results reported are the differences immediately and at 6 weeks post-stimulation from the mean of the baseline 4 weeks of pre-stimulation scores. | Mean | Standard Deviation | units on a scale |
|
| Hospital Anxiety and Depression Scale-Depression | 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). Results reported are the differences immediately and at 6 weeks post-stimulation from the mean of the baseline 4 weeks of pre-stimulation scores. | Mean | Standard Deviation | units on a scale |
|
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.
| OG001 | Vermis Transcranial Magnetic Stimulation | 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. |
| OG002 | Cerebellar Hemisphere Control Transcranial Magnetic Stimulation | 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. |
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| Secondary | Mal de Debarquement Balance Rating Scale | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks (4 pre stimulation + 6 post stimulation) |
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| Secondary | Hospital Anxiety and Depression Scale | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | 10 weeks (4 pre stimulation + 6 post stimulation) |
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Target 2 Transcranial Magnetic Stimulation | 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. | 0 | 9 | 0 | 9 | 0 | 9 |
| EG002 | Target 3 Control Site Transcranial Magnetic Stimulation | 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. | 0 | 5 | 0 | 5 | 0 | 5 |
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| Immediate change-Depression |
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| 6 week change-Depression |
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