Trial Outcomes & Findings for A Study of Home-Delivered Neurostimulation for Migraine (NCT NCT03874351)
NCT ID: NCT03874351
Last Updated: 2021-12-17
Results Overview
A migraine day is defined as any calendar day on which the patient had onset, continuation, or recurrence of a migraine as recorded in the diary. A migraine is defined as a migraine (with or without aura) lasting at least 30 minutes. Any calendar day on which acute migraine medication is used is counted as a migraine day.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point);
Results posted on
2021-12-17
Participant Flow
Participants were recruited at the New York Headache Center, New York City, NY, USA, between 3/12/2019 and 3/5/2020.
Thirty six patients have been identified. Six declined to participate, 14 did not meet the Inclusion/Exclusion criteria. Twenty two proceeded with the study, were randomized and received the study intervention. The first of the twenty-two patients entered the study on 4/22/19; the last patient out completed the study intervention on 4/10/2020, with the last study visit on 4/13/2020 and the last phone follow-up on 5/12/2020.
Participant milestones
| Measure |
Active tDCS
The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
Sham tDCS
Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
7
|
9
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Home-Delivered Neurostimulation for Migraine
Baseline characteristics by cohort
| Measure |
Active tDCS
n=11 Participants
The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
Sham tDCS
n=11 Participants
Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White, Non-Hispanic
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Migraine days per month
|
25 migraine days per month
n=5 Participants
|
17 migraine days per month
n=7 Participants
|
23 migraine days per month
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 30 of the intervention (secondary time point), Day 60 of the intervention (primary time point);Population: Participants who met the Inclusion/Exclusion criteria for the study.
A migraine day is defined as any calendar day on which the patient had onset, continuation, or recurrence of a migraine as recorded in the diary. A migraine is defined as a migraine (with or without aura) lasting at least 30 minutes. Any calendar day on which acute migraine medication is used is counted as a migraine day.
Outcome measures
| Measure |
Active tDCS
n=11 Participants
The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
Sham tDCS
n=11 Participants
Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
|---|---|---|
|
Migraine Days Per Month
Migraine days per month at day 60 of the intervention (primary outcome) (primary)
|
-8 migraine days per month
Interval -9.0 to 0.0
|
-4 migraine days per month
Interval -6.0 to 0.0
|
|
Migraine Days Per Month
Migraine days per month at day 30 of the intervention (secondary outcome)
|
-3 migraine days per month
Interval -6.0 to -1.0
|
-3 migraine days per month
Interval -5.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 60 of the interventionPopulation: Participants who met the Inclusion/Exclusion criteria of the study
determined as a percentage of patients having at least 50% reduction of monthly migraine days between the one-month baseline and post-intervention, in each of the two study groups
Outcome measures
| Measure |
Active tDCS
n=11 Participants
The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
Sham tDCS
n=11 Participants
Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
|---|---|---|
|
Percentage of Responders
|
18.18 percentage of participants
|
36.36 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Day 30 of the intervention, Day 60 of the interventionPopulation: Participants who met the Inclusion/Exclusion criteria of the study.
Median change in number of attacks per 30-day period, determined from the patients' diaries
Outcome measures
| Measure |
Active tDCS
n=11 Participants
The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
Sham tDCS
n=11 Participants
Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
|---|---|---|
|
Migraine Attack Frequency
Migraine attack frequency at day 60 of the interrvention
|
-1 migraine attacks per month
Interval -3.0 to 0.0
|
-2 migraine attacks per month
Interval -4.0 to -1.0
|
|
Migraine Attack Frequency
Migraine attack frequency at day 30 of the intervention
|
1 migraine attacks per month
Interval 0.0 to 2.0
|
0 migraine attacks per month
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Day 30 of the intervention, Day 60 of the interventionPopulation: Participants who met the Inclusion/Exclusion criteria of the study
Acute antimigraine drug use per month determined from the patient's diaries. Median change in number of days on which an acute medication was used.
Outcome measures
| Measure |
Active tDCS
n=11 Participants
The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
Sham tDCS
n=11 Participants
Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
|---|---|---|
|
Acute Medication Use
Acute antimigraine drug use - day 30 of the intervention
|
-1 Days/month
Interval -3.0 to 0.0
|
-1 Days/month
Interval -4.0 to 0.0
|
|
Acute Medication Use
Acute antimigraine drug use - day 60 of the intervention
|
-2 Days/month
Interval -4.0 to 0.0
|
-2 Days/month
Interval -9.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Day 30 of the intervention, Day 60 of the intervention;Population: Participants who met the Inclusion/Exclusion criteria of the study.
Determined from the 11-point \[0-10\] Pain Numerical Rating Scale (Pain NRS) on migraine days in the patients' diaries. Higher ratings on the Pain NRS reflect higher intensity of pain.
Outcome measures
| Measure |
Active tDCS
n=11 Participants
The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
Sham tDCS
n=11 Participants
Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
|---|---|---|
|
Change in Headache Attack Intensity Median Change in NRS From Headache Days in a 30 Day Period
Change in headache attack intensity - day 30 of the intervention
|
0 Score on a scale
Interval 0.0 to 0.0
|
-1 Score on a scale
Interval -1.0 to 0.0
|
|
Change in Headache Attack Intensity Median Change in NRS From Headache Days in a 30 Day Period
Change in headache attack intensity - day 60 of the intervention
|
-1 Score on a scale
Interval -2.0 to 0.0
|
-1 Score on a scale
Interval -1.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Day 30 of the intervention, Day 60 of the intervention;Population: Participants who met the Inclusion/Exclusion criteria of the study.
Determined from ratings on the migraine-specific MSQ questionnaire. The questionnaire consists of 14 items, each rated on a scale 1-6, with the total score ranging between 14 and 84. Higher scores reflect poorer quality of life.
Outcome measures
| Measure |
Active tDCS
n=11 Participants
The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
Sham tDCS
n=11 Participants
Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
|---|---|---|
|
Change in Quality of Life: The Migraine Specific Quality of Life Questionnaire (MSQ)
Change in quality of life - day 30 of the intervention
|
-11 Score on a scale
Interval -18.0 to -5.0
|
-7 Score on a scale
Interval -11.0 to -2.0
|
|
Change in Quality of Life: The Migraine Specific Quality of Life Questionnaire (MSQ)
Change in quality of life - day 60 of the intervention
|
-12 Score on a scale
Interval -18.0 to -10.0
|
-8 Score on a scale
Interval -25.0 to -1.0
|
SECONDARY outcome
Timeframe: Baseline, Day 30 of the intervention, Day 60 of the intervention;Population: Participants who met the Inclusion/Exclusion criteria of the study
Determined from the Hamilton Depression Scale (HamD) that consists of 21 items with numerically rated responses ranging 0-2 or 0-4. Higher Ham-D score reflects more severe depression.
Outcome measures
| Measure |
Active tDCS
n=11 Participants
The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
Sham tDCS
n=11 Participants
Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
|---|---|---|
|
Change in Depressive Symptoms
Change in depressive symptoms - day 30 of the intervention
|
-4 Score on a scale
Interval -7.0 to -3.0
|
-2 Score on a scale
Interval -4.0 to 0.0
|
|
Change in Depressive Symptoms
Change in depressive symptoms - day 60 of the intervention
|
-5 Score on a scale
Interval -7.0 to -4.0
|
-3 Score on a scale
Interval -6.0 to 0.0
|
SECONDARY outcome
Timeframe: from Day 1 of the study intervention to the end of the safety follow-up thirty days after the last tDCS applicationPopulation: Participants who met the Inclusion/Exclusion criteria of the study.
Determined as number of side effects and adverse events related, probably related or possibly related to the study intevention
Outcome measures
| Measure |
Active tDCS
n=11 Participants
The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
Sham tDCS
n=11 Participants
Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
|---|---|---|
|
Tolerability of the Study Intervention: Number of Side Effects and Adverse Events
|
3 events
|
0 events
|
SECONDARY outcome
Timeframe: Day 60 of the interventionPopulation: Participants who met the Inclusion/Exclusion criteria of the study
Patient's satisfaction with the study intervention determined from the 8-item tDCS User Survey at the end of the intervention. Each item of the Survey is a brief statement and a respondent indicates if s/he Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree with the statement. Higher number of Agree/Strongly Agree ratings reflects higher satisfaction with the tDCS procedure.
Outcome measures
| Measure |
Active tDCS
n=11 Participants
The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
Sham tDCS
n=11 Participants
Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
|---|---|---|
|
Patient's Satisfaction: 8-item tDCS User Survey
|
41 number of Agree/Strongly Agree ratings
|
57 number of Agree/Strongly Agree ratings
|
Adverse Events
Active tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active tDCS
n=11 participants at risk
The active tDCS will involve 20-minutes of direct current at intensity of 1.5 milliamperes (mA).
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
Sham tDCS
n=11 participants at risk
Sham will include 30 seconds of stimulation at 1.5 mA, followed by 0 mA for the remaining time.
non-invasive transcranial direct current stimulation (tDCS): Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/11 • Three months (through the two-month neurostimulation period plus 30 days after the last stimulation).
|
9.1%
1/11 • Number of events 2 • Three months (through the two-month neurostimulation period plus 30 days after the last stimulation).
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 3 • Three months (through the two-month neurostimulation period plus 30 days after the last stimulation).
|
0.00%
0/11 • Three months (through the two-month neurostimulation period plus 30 days after the last stimulation).
|
Additional Information
Helena Knotkova, PhD, PhilD
MJHS Institute for Innovation in Palliative Care, New York, NY
Phone: 646-784-2262
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place