Trial Outcomes & Findings for Transcranial Magnetic Stimulation for Attention Deficit/Hyperactivity Disorder (ADHD) (NCT NCT03663179)
NCT ID: NCT03663179
Last Updated: 2022-08-05
Results Overview
ADHD symptoms will be assessed using the well-validated Conners Adult ADHD Rating Scale - Self-Report: Long Version (CAARS-S:L). The CAARS-S:L is a 66-item rating scale designed to assess ADHD symptoms in adults. The scale contains multiple subscales to assess Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) specified ADHD criteria as well as other facets of ADHD such as inattention/memory problems, hyperactivity/restlessness, impulsivity/emotionality, and problems with self-concept. Subscale results are converted to T-scores (range: 25-90), where 50 is the standardized population mean and every 10 points indicates one standard deviation from the mean. Higher values generally indicate more difficulties with ADHD symptoms. This measure will be administered at baseline at at the end of 4 weeks of treatment. The primary outcome will be the change from baseline to week 4.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Baseline and week 4
Results posted on
2022-08-05
Participant Flow
Participant milestones
| Measure |
Active TMS
Participants will receive 20 sessions of active TMS targeting the left DLPFC.
Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
|
Sham TMS
Participants will receive 20 sessions of sham TMS over the left DLPFC.
Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
14
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Active TMS
Participants will receive 20 sessions of active TMS targeting the left DLPFC.
Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
|
Sham TMS
Participants will receive 20 sessions of sham TMS over the left DLPFC.
Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Revealed exclusionary condition
|
1
|
0
|
Baseline Characteristics
Transcranial Magnetic Stimulation for Attention Deficit/Hyperactivity Disorder (ADHD)
Baseline characteristics by cohort
| Measure |
Active TMS
n=14 Participants
Participants will receive 20 sessions of active TMS targeting the left DLPFC.
Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
|
Sham TMS
n=13 Participants
Participants will receive 20 sessions of sham TMS over the left DLPFC.
Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.9 years
STANDARD_DEVIATION 9.9 • n=99 Participants
|
36.0 years
STANDARD_DEVIATION 6.0 • n=107 Participants
|
34.4 years
STANDARD_DEVIATION 13.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Education
high school/some college
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Education
college graduate
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Smoking Status
smokers
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Smoking Status
non-smokers
|
10 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 4ADHD symptoms will be assessed using the well-validated Conners Adult ADHD Rating Scale - Self-Report: Long Version (CAARS-S:L). The CAARS-S:L is a 66-item rating scale designed to assess ADHD symptoms in adults. The scale contains multiple subscales to assess Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) specified ADHD criteria as well as other facets of ADHD such as inattention/memory problems, hyperactivity/restlessness, impulsivity/emotionality, and problems with self-concept. Subscale results are converted to T-scores (range: 25-90), where 50 is the standardized population mean and every 10 points indicates one standard deviation from the mean. Higher values generally indicate more difficulties with ADHD symptoms. This measure will be administered at baseline at at the end of 4 weeks of treatment. The primary outcome will be the change from baseline to week 4.
Outcome measures
| Measure |
Active TMS
n=14 Participants
Participants will receive 20 sessions of active TMS targeting the left DLPFC.
Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
|
Sham TMS
n=13 Participants
Participants will receive 20 sessions of sham TMS over the left DLPFC.
Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
|
|---|---|---|
|
Change in Performance on Conners Adult ADHD Rating Scale - Self-Report: Long Version (ADHD Symptoms)
|
-4.4 t-score
Standard Deviation 9.4
|
-5.1 t-score
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline and week 4The Conners Continuous Performance Task (Conners CPT) will be administered and baseline and weekly during the treatment period to assess sustained attention. In this task, participants are shown a series of letters on a computer screen and are asked to press the spacebar in response to all letters except for the letter X. The primary outcome for the Conners CPT is the change in number of commission errors (e.g., false positives) from baseline to week 4.
Outcome measures
| Measure |
Active TMS
n=14 Participants
Participants will receive 20 sessions of active TMS targeting the left DLPFC.
Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
|
Sham TMS
n=13 Participants
Participants will receive 20 sessions of sham TMS over the left DLPFC.
Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
|
|---|---|---|
|
Change in Performance on Conners Continuous Performance Task (Sustained Attention)
|
-16.2 Commission Errors
Standard Deviation 17.6
|
-4.8 Commission Errors
Standard Deviation 18.0
|
Adverse Events
Active TMS
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sham TMS
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 TMS
n=18 participants at risk
Participants will receive 20 sessions of active TMS targeting the left DLPFC.
Transcranial Magnetic Stimulation (TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (\~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
|
Sham TMS
n=14 participants at risk
Participants will receive 20 sessions of sham TMS over the left DLPFC.
Sham Transcranial Magnetic Stimulation (Sham TMS): A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
|
|---|---|---|
|
General disorders
Sleep disturbance
|
5.6%
1/18 • Number of events 1 • Baseline until end of treatment, an average of 4 weeks.
|
0.00%
0/14 • Baseline until end of treatment, an average of 4 weeks.
|
|
Immune system disorders
allergic reaction
|
5.6%
1/18 • Number of events 1 • Baseline until end of treatment, an average of 4 weeks.
|
0.00%
0/14 • Baseline until end of treatment, an average of 4 weeks.
|
|
Eye disorders
Visual disturbance
|
0.00%
0/18 • Baseline until end of treatment, an average of 4 weeks.
|
7.1%
1/14 • Number of events 1 • Baseline until end of treatment, an average of 4 weeks.
|
|
Injury, poisoning and procedural complications
Injury
|
5.6%
1/18 • Number of events 1 • Baseline until end of treatment, an average of 4 weeks.
|
0.00%
0/14 • Baseline until end of treatment, an average of 4 weeks.
|
|
Psychiatric disorders
Depression symptoms
|
5.6%
1/18 • Number of events 1 • Baseline until end of treatment, an average of 4 weeks.
|
0.00%
0/14 • Baseline until end of treatment, an average of 4 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place