N/A
N=15
Low Frequency TMS for Depression in Epilepsy
Epilepsy · Depressions, Refractory
Bottom Line
View on ClinicalTrials.gov: NCT03105700 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Change in Seizure Frequency Expressed as the Average Number of Seizures Experienced by All Participants and Recorded at Specified Time Points Throughout the Study. — 5.83; 0; 1.42; 1.0 average number of seizures
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Magnetic Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Seizure Frequency Expressed as the Average Number of Seizures Experienced by All Participants and Recorded at Specified Time Points Throughout the Study. |
5.83; 0; 1.42; 1.0 | — |
| PRIMARY Percentage of Participants Who Complete the TMS Treatment |
12 | — |
| PRIMARY Number of Treatment-emergent Adverse Events as Measured by a Modified Systematic Assessment for Treatment Emergent Events (SAFTEE). |
1 | — |
| PRIMARY Measuring Biomarker for Depression Using Dense-array EEG |
1.29; 1.10; 1.35 | — |
| SECONDARY Changes in Depression Severity Related to the Study Interventions. |
16.9; 8.2; 8.7; 8.8; 9.6 | — |
Summary
The purpose of this study is to determine if low-frequency transcranial magnetic stimulation (TMS) is safe and feasible for treating depressive symptoms in patients with epilepsy. Patients will receive an accelerated protocol of TMS consisting of three consecutive days of treatment. Patients will have in-person follow up visits after one month and again after six months.
Eligibility Criteria
Inclusion Criteria
- Age 18 or older
- Able and willing to provide informed consent.
- Diagnosis of epilepsy confirmed by the study neurologist (KB).
- English-speaking
- Not pregnant
- Able to safely undergo MRI (as assessed by MRI safety form).
- Have a family member or friend (proxy) who will be able to bring the patient to the hospital and serve as a safety monitor during stay in study hotel for two consecutive nights.
- Patients on stable doses of current antiepileptic and antidepressant medications for 1 month.
Exclusion Criteria
- Significant cognitive impairment measured by the Montreal Cognitive Assessment (MOCA) 2 or Mini-International Neuropsychiatric Interview (MINI) Suicidality module score > 16)
- Greater than 10 seizures per week during 1 month prior.
- History of stroke, moderate-severe traumatic brain injury or other major neurological disorder.
- Any magnetic or implanted device that will interfere with ability to safely receive MRI and/or TMS treatment.
Data sourced from ClinicalTrials.gov (NCT03105700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.