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Amantadine + rTMS as a Neurotherapeutic for Disordered Consciousness

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ClinicalTrials.gov Identifier: NCT02025439
Recruitment Status : Completed
First Posted : January 1, 2014
Results First Posted : August 24, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
Theresa Pape, Edward Hines Jr. VA Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Traumatic Brain Injury
Interventions Device: rTMS
Drug: Amantadine
Enrollment 4
Recruitment Details  
Pre-assignment Details nothing to report
Arm/Group Title rTMS Alone Followed by rTMS+AMA AMA Alone Followed by rTMS+AMA
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 2 2
Completed 2 2
Not Completed 0 0
Arm/Group Title rTMS First Amantadine First Total
Hide Arm/Group Description

Subjects assigned to rTMS Alone will receive 30 sessions of rTMS. Two rTMS sessions will be provided per day, four days per week.

rTMS

Subjects who are assigned to the Amantadine Alone group will receive 28 doses of Amantadine (100mg BID) every day for 28 days.

Amantadine

Total of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
2
 100.0%
4
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 4 participants
24
(21 to 27)
33
(28 to 37)
28
(21 to 37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
0
   0.0%
1
  50.0%
1
  25.0%
Male
2
 100.0%
1
  50.0%
3
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2 2 4
1.Primary Outcome
Title Intensity of Adverse Event
Hide Description 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).
Time Frame 30 days after treatment "alone" and an additional 30 days after treatment "combined" (i.e., 60 days)
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title rTMS Alone rTMS+AMA AMA Alone
Hide Arm/Group Description:
Subjects assigned to start with rTMS Alone
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.
Subjects assigned to start with amantadine alone
Overall Number of Participants Analyzed 2 4 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
0.5  (0.52) 0.98  (0.38) 0.33  (0.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection rTMS Alone, rTMS+AMA
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.071
Estimation Comments [Not Specified]
Time Frame 3 months and 6 months
Adverse Event Reporting Description 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.
 
Arm/Group Title rTMS Alone rTMS+AMA AMA Alone
Hide Arm/Group Description Subjects assigned to rTMS Alone 30 sessions of rTMS. Two rTMS sessions will be provided per day, four days per week. 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. Subjects who are assigned to the Amantadine Alone group will receive 28 doses of Amantadine (100mg BID) every day for 28 days.
All-Cause Mortality
rTMS Alone rTMS+AMA AMA Alone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/4 (0.00%)      0/2 (0.00%)    
Hide Serious Adverse Events
rTMS Alone rTMS+AMA AMA Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/4 (0.00%)      0/2 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
rTMS Alone rTMS+AMA AMA Alone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      4/4 (100.00%)      2/2 (100.00%)    
General disorders       
Fatigue   2/2 (100.00%)  2 2/4 (50.00%)  19 1/2 (50.00%)  4
Fever   1/2 (50.00%)  1 0/4 (0.00%)  0 0/2 (0.00%)  0
hypertension   1/2 (50.00%)  1 2/4 (50.00%)  7 0/2 (0.00%)  0
Hypotension   0/2 (0.00%)  0 2/4 (50.00%)  10 1/2 (50.00%)  8
Infection at IV site   0/2 (0.00%)  0 2/4 (50.00%)  2 0/2 (0.00%)  0
Weight Loss   0/2 (0.00%)  0 1/4 (25.00%)  2 0/2 (0.00%)  0
Neurocheck   2/2 (100.00%)  3 3/4 (75.00%)  8 0/2 (0.00%)  0
Seizure   0/2 (0.00%)  0 0/4 (0.00%)  0 0/2 (0.00%)  0
Skin breakdown at venous site   0/2 (0.00%)  0 1/4 (25.00%)  4 0/2 (0.00%)  0
General Skin Integrity   0/2 (0.00%)  0 1/4 (25.00%)  2 0/2 (0.00%)  0
Skin breakdown at scalp   0/2 (0.00%)  0 1/4 (25.00%)  4 0/2 (0.00%)  0
Sweating   1/2 (50.00%)  1 1/4 (25.00%)  2 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Theresa Bender-Pape
Organization: Edward Hines VA Hospital
Phone: 708-202-4953
EMail: Theresa.BenderPape@va.gov
Layout table for additonal information
Responsible Party: Theresa Pape, Edward Hines Jr. VA Hospital
ClinicalTrials.gov Identifier: NCT02025439    
Other Study ID Numbers: 1R21HD075192 ( U.S. NIH Grant/Contract )
First Submitted: December 23, 2013
First Posted: January 1, 2014
Results First Submitted: July 29, 2019
Results First Posted: August 24, 2020
Last Update Posted: August 24, 2020