Essential Tremor
Conditions
Brief summary
The purpose of this study is to determine the effects of Low Frequency Repetitive Transcranial Magnetic Stimulation (LF r-TMS) of the pre-Supplementary Motor Area (pre-SMA) on tremor as measured by the tremor rating scale (TRS) in patients with Essential Tremor (ET). Hypothesis: Pre-SMA LF r-TMS will result in a \>30% reduction in tremor as measured by the TRS. Another purpose of this study is to identify the mechanism by which LF r-TMS of the pre-SMA effects tremor in patients with ET. Hypothesis: Inhibition of the pre-SMA by LF r-TMS improves tremor in ET by normalizing pre-SMA output, and improving motor control, as determined shortening of the delay in the second agonist burst, seen in ET patients. At conclusion of this study expect to have sufficient pilot data to justify larger pivotal trials designed to establish the efficacy of pre-SMA r-TMS in ET.
Interventions
DEVICEMagVenture MagProx100 Stimulator with a Cool-B65 A/P coil
Active rTMS administration (1Hz, 1,200sec, 110% resting motor threshold (rMT); 1200 pulses total. Resting motor threshold assessment the TMS machine will initially be set to 50% of its maximal output.
DEVICEeSHAM system
implemented in conjunction with the Cool-B65 A/P coil to effectively blind participants to rTMS treatment (active or sham)
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Greater than 18 of age * Meet the diagnostic criteria for essential tremor with visible upper limb tremor * Must be either on stable medications to treat tremor for 30 days, or no medications to treat tremor
Exclusion criteria
* History of seizures * History of chronic pain conditions * Any metal in their body above their shoulders * Use of medications that lower seizure threshold including: * broad classes of drugs such as tricyclic antidepressants * anti-psychotics * neuroeptics * thyroid medications and stimulants * Use of any medications that cause tremor, Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean TRS (Tremor Rating Score) | Baseline (Visit 2) post intervention | Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor) |
| Mean TRS (Tremor Rating Score) at 4 Week Followup | 4 week followup(visit 18) | Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor) |
| Mean TRS (Tremor Rating Score) at 8 Week Followup | 8 week followup (visit 19) | Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor) |
| Mean TRS (Tremor Rating Score) at 12 Week Followup | 12-week followup(visit 20) | Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor) |
Participant flow
Recruitment details
clinic
Pre-assignment details
screening procedures per inclusion and exclusion criteria, no wash out, stayed on meds.
Participants by arm
| Arm | Count |
|---|---|
| Active active tms | 5 |
| Sham sham tms | 5 |
| Total | 10 |
Baseline characteristics
| Characteristic | Active | Sham | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Continuous | 71.6 years STANDARD_DEVIATION 12.17 | 71.6 years STANDARD_DEVIATION 12.17 | 71.6 years STANDARD_DEVIATION 12.17 |
| Mean TRS at Baseline Visit | 36.0 units on a scale STANDARD_DEVIATION 8.276 | 34 units on a scale STANDARD_DEVIATION 5.385 | 35 units on a scale STANDARD_DEVIATION 6.667 |
| Region of Enrollment United States | 5 participants | 5 participants | 10 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Mean TRS (Tremor Rating Score)
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Time frame: Baseline (Visit 2) post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Mean TRS (Tremor Rating Score) | 26.6 units on a scale | Standard Deviation 7.701 |
| Sham | Mean TRS (Tremor Rating Score) | 27.6 units on a scale | Standard Deviation 8.325 |
Primary
Mean TRS (Tremor Rating Score) at 12 Week Followup
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Time frame: 12-week followup(visit 20)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Mean TRS (Tremor Rating Score) at 12 Week Followup | 32.8 units on a scale | Standard Deviation 7.294 |
| Sham | Mean TRS (Tremor Rating Score) at 12 Week Followup | 29.6 units on a scale | Standard Deviation 8.264 |
Primary
Mean TRS (Tremor Rating Score) at 4 Week Followup
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Time frame: 4 week followup(visit 18)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Mean TRS (Tremor Rating Score) at 4 Week Followup | 29.60 units on a scale | Standard Deviation 9.555 |
| Sham | Mean TRS (Tremor Rating Score) at 4 Week Followup | 29.2 units on a scale | Standard Deviation 5.891 |
Primary
Mean TRS (Tremor Rating Score) at 8 Week Followup
Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)
Time frame: 8 week followup (visit 19)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Mean TRS (Tremor Rating Score) at 8 Week Followup | 29.6 units on a scale | Standard Deviation 9.555 |
| Sham | Mean TRS (Tremor Rating Score) at 8 Week Followup | 29.6 units on a scale | Standard Deviation 5.771 |