Trial Outcomes & Findings for Amantadine + rTMS as a Neurotherapeutic for Disordered Consciousness (NCT NCT02025439)
NCT ID: NCT02025439
Last Updated: 2020-08-24
Results Overview
If an adverse event occurred, the intensity was also indicated. The intensity of an adverse event was determined using a scale from 1-5 with 5 being the worst. The purpose of the study is to examine safety of rTMS combined with AMA relative to rTMS Alone and AMA alone. Results are not reported "per arm" rather, the arms are combined so as to compare the outcome when the interventions are provided separately (i.e., rTMS alone and amantadine alone) vs interventions are combined (rTMS +Amantadine alone).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
30 days after treatment "alone" and an additional 30 days after treatment "combined" (i.e., 60 days)
Results posted on
2020-08-24
Participant Flow
nothing to report
Participant milestones
| Measure |
rTMS Alone Followed by rTMS+AMA
Subjects assigned to rTMS Alone will receive 30 sessions of rTMS. Two rTMS sessions will be provided per day, four days per week.upon completion of assigned treatment order, the subject will then receive 30 sessions of combination therapy of rTMS + Amantadine
rTMS
|
AMA Alone Followed by rTMS+AMA
Subjects who are assigned to the Amantadine Alone group will receive 28 doses of Amantadine (100mg BID) every day for 28 days. upon completion of assigned treatment order, the subject will then receive 30 sessions of combination therapy of rTMS + Amantadine
Amantadine
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Amantadine + rTMS as a Neurotherapeutic for Disordered Consciousness
Baseline characteristics by cohort
| Measure |
rTMS First
n=2 Participants
Subjects assigned to rTMS Alone will receive 30 sessions of rTMS. Two rTMS sessions will be provided per day, four days per week.
rTMS
|
Amantadine First
n=2 Participants
Subjects who are assigned to the Amantadine Alone group will receive 28 doses of Amantadine (100mg BID) every day for 28 days.
Amantadine
|
Total
n=4 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24 years
n=5 Participants
|
33 years
n=7 Participants
|
28 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 days after treatment "alone" and an additional 30 days after treatment "combined" (i.e., 60 days)Population: Results are reported both "per arm" at the end of 30 days when a single treatment (either rTMS or AMA) was ended, and additional results are reported with both arms combined to report the outcome after 60 days
If an adverse event occurred, the intensity was also indicated. The intensity of an adverse event was determined using a scale from 1-5 with 5 being the worst. The purpose of the study is to examine safety of rTMS combined with AMA relative to rTMS Alone and AMA alone. Results are not reported "per arm" rather, the arms are combined so as to compare the outcome when the interventions are provided separately (i.e., rTMS alone and amantadine alone) vs interventions are combined (rTMS +Amantadine alone).
Outcome measures
| Measure |
rTMS Alone
n=2 Participants
Subjects assigned to start with rTMS Alone
|
rTMS+AMA
n=4 Participants
All subjects that received rTMS plus Amantadine. A total of 30 rTMS sessions are provided, 2 rTMS sessions per day, four days per week, while receiving 200mg of Amantadine daily.
|
AMA Alone
n=2 Participants
Subjects assigned to start with amantadine alone
|
|---|---|---|---|
|
Intensity of Adverse Event
|
0.5 score on a scale
Standard Deviation 0.52
|
0.98 score on a scale
Standard Deviation 0.38
|
0.33 score on a scale
Standard Deviation 0.51
|
Adverse Events
rTMS Alone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
rTMS+AMA
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AMA Alone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
rTMS Alone
n=2 participants at risk
Subjects assigned to rTMS Alone 30 sessions of rTMS. Two rTMS sessions will be provided per day, four days per week.
|
rTMS+AMA
n=4 participants at risk
Subjects who are assigned to the Amantadine Alone group will receive 28 doses of Amantadine (100mg BID) every day for 28 days.Then, A total of 30 rTMS sessions are provided, 2 rTMS sessions per day, four days per week, while receiving 200mg of Amantadine daily.
|
AMA Alone
n=2 participants at risk
Subjects who are assigned to the Amantadine Alone group will receive 28 doses of Amantadine (100mg BID) every day for 28 days.
|
|---|---|---|---|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
50.0%
2/4 • Number of events 19 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
50.0%
1/2 • Number of events 4 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
|
General disorders
Fever
|
50.0%
1/2 • Number of events 1 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
0.00%
0/4 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
|
General disorders
hypertension
|
50.0%
1/2 • Number of events 1 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
50.0%
2/4 • Number of events 7 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
|
General disorders
Hypotension
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
50.0%
2/4 • Number of events 10 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
50.0%
1/2 • Number of events 8 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
|
General disorders
Infection at IV site
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
50.0%
2/4 • Number of events 2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
|
General disorders
Weight Loss
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
25.0%
1/4 • Number of events 2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
|
General disorders
Neurocheck
|
100.0%
2/2 • Number of events 3 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
75.0%
3/4 • Number of events 8 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
|
General disorders
Seizure
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
0.00%
0/4 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
|
General disorders
Skin breakdown at venous site
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
25.0%
1/4 • Number of events 4 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
|
General disorders
General Skin Integrity
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
25.0%
1/4 • Number of events 2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
|
General disorders
Skin breakdown at scalp
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
25.0%
1/4 • Number of events 4 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
|
General disorders
Sweating
|
50.0%
1/2 • Number of events 1 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
25.0%
1/4 • Number of events 2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
0.00%
0/2 • 3 months and 6 months
A Clinical Data Monitoring Log was used to record. Most were collected daily. CNS changes were collected once during MRI scan. clinical indices include fatigue, fever, hypertension, hypotension, infection at IV site, weight loss/gain, seizures, skin breakdown at IV site, skin breakdown on scalp, general skin breakdown, sweating and neurochecks hourly between rTMS sessions on the same day.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place