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Regulating Homeostatic Plasticity and the Physiological Response to rTMS

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ClinicalTrials.gov Identifier: NCT03309696
Recruitment Status : Terminated (Funding issues)
First Posted : October 13, 2017
Results First Posted : November 6, 2020
Last Update Posted : November 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Tinnitus
Interventions Device: sham tDCS and sham rTMS
Device: sham tDCS and active rTMS
Device: active tDCS and active rTMS
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title tDCS and 1 Hz rTMS Delivered Over TC tDCS Over DLFC and 1 Hz rTMS Over TC tDCS and 10Hz rTMS Delivered Over TC tDCS Over DLFC and 10 Hz rTMS Over TC
Hide Arm/Group Description

Participants receive sham and active 2mA tDCS over the temporal cortex (TC) prior to receiving sham and active 1 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC. .

sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.

sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active

active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active

Participants receive sham and active 2mA tDCS over the dorsolateral frontal cortex (DLFC) prior to receiving sham and active 1 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.

sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.

sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active

active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active

Participants receive sham and active 2mA tDCS over the temporal cortex (TC) prior to receiving sham and active 10 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.

sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.

sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active

active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active

Participants receive sham and active 2mA tDCS over the dorsolateral frontal cortex (DLFC) prior to receiving sham and active 10 Hz rTMS (900 rTMS pulses at 110% motor threshold) delivered to the TC.

sham tDCS and sham rTMS: Both combinations of tDCS and rTMS in this intervention are sham.

sham tDCS and active rTMS: tDCS in this intervention is sham and rTMS is active

active tDCS and active rTMS: Both combinations of tDCS and rTMS in this intervention are active

Period Title: Overall Study
Started 5 [1] 5 [1] 0 0
Completed 5 0 0 0
Not Completed 0 5 0 0
Reason Not Completed
Analysis of TEP data could not be completed             0             5             0             0
[1]
All five subjects in this arm were randomize to all sham and active tDCS and rTMS interventions.
Arm/Group Title tDCS and 1 Hz rTMS Delivered Over TC tDCS and 1 Hz rTMS Delivered Over DLPF Total
Hide Arm/Group Description Baseline characteristics for participants assigned to the arm that received tDCS and 1Hz rTMS over the temporal cortex. Baseline characteristics for participants assigned to the arm that received tDCS and 1Hz rTMS over the dorsolateral frontal cortex. Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
Baseline characteristics are reported for the two arms to which subjects were assigned.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
35.8  (16.8) 32  (15.14) 33.9  (14.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
4
  80.0%
4
  80.0%
8
  80.0%
Male
1
  20.0%
1
  20.0%
2
  20.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Hispanic or Latino
0
   0.0%
1
  20.0%
1
  10.0%
Not Hispanic or Latino
5
 100.0%
4
  80.0%
9
  90.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
American Indian or Alaska Native
0
   0.0%
1
  20.0%
1
  10.0%
Asian
0
   0.0%
1
  20.0%
1
  10.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
5
 100.0%
2
  40.0%
7
  70.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
  20.0%
1
  10.0%
Mean baseline P100 amplitude of the GMFA   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  µV
Number Analyzed 5 participants 0 participants 5 participants
1.29  (0.47) 1.29  (0.47)
[1]
Measure Description: The mean of the P100 amplitude during a baseline recording, before any of the tDCS or rTMS interventions have been introduced.
[2]
Measure Analysis Population Description: Outcome measures are not reported for the DLPF arm because, due to insufficient resources and the required personnel needed to perform the data cleaning and pipeline analysis, no P100 amplitude data can be reported.
1.Primary Outcome
Title Log Transformed P100 Amplitude of TEPs From the Global Mean Field Analysis.
Hide Description TEPs refer to TMS-evoked EEG potentials. The P100 amplitude of TEPs is one means of assessing cortical excitability. The P100 amplitude has been shown to be a reliable metric in studies of healthy subjects. The P100 amplitude is used in this study to assess the excitation state of two regions of interest (ROIs), one in the TC and one in the DLPFC, at each period of TEP recording (i.e., Baseline, Post tDCS, Post rTMS, and 20 minute delay).
Time Frame Up to 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analyses population is 5 subjects who were assigned to the arm "tDCS and 1 Hz rTMS over the temporal cortex". The group titles reflect sequences of sham and active tDCS and rTMS conditions used to create contrasts for data analysis. Outcome measures are not reported for the DLPF arm because, due to insufficient resources and the required personnel needed to perform the extensive data cleaning and pipeline analysis, no P100 amplitude data can be reported.
Arm/Group Title Sham tDCS Preconditioning Active tDCS Preconditioning Sham tDCS Preconditioning of Sham rTMS Sham tDCS Preconditioning of Active rTMS Active tDCS Preconditioning of Active rTMS
Hide Arm/Group Description:
TEPs recorded post sham tDCS but before rTMS.
TEPs recorded after active tDCS preconditioning but before rTMS.
TEPs recorded after sham tDCS preconditioning and sham rTMS.
TEPs recorded after sham tDCS preconditioning and active rTMS.
TEPs recorded after active tDCS preconditioning and active rTMS.
Overall Number of Participants Analyzed 5 5 5 5 5
Mean (Standard Deviation)
Unit of Measure: log µV
1.85  (0.71) 1.26  (0.33) 1.59  (0.82) 1.30  (0.58) 1.11  (0.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham tDCS Preconditioning, Active tDCS Preconditioning
Comments Examines the effect of tDCS preconditioning on P100 amplitudes. The effect size for this comparison was .33 (Cohen's).
Type of Statistical Test Equivalence
Comments A p value of <.0.05 is taken as evidence of nonequivalence.
Statistical Test of Hypothesis P-Value .055
Comments The p value is not adjusted because it was a planned contrast.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -.59
Estimation Comments Active tDCS - sham tDCS.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sham tDCS Preconditioning, Sham tDCS Preconditioning of Active rTMS
Comments Examines the effect of rTMS on the P100 amplitude. The calculated effect size is .35 (Cohen's).
Type of Statistical Test Equivalence
Comments A p value of <.05 is taken as evidence of nonequivalence.
Statistical Test of Hypothesis P-Value 0.0418
Comments This p value is not adjusted for multiple comparisons because it was a planned contrast.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value .36
Estimation Comments Sham tDCS - Sham tDCS and Active rTMS
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Sham tDCS Preconditioning of Active rTMS, Active tDCS Preconditioning of Active rTMS
Comments Examines the additive effect of tDCS preconditioning on the P100 amplitude after rTMS. The effect size for this comparison was 0.14.
Type of Statistical Test Equivalence
Comments A p value less than 0.05 is taken as evidence of nonequivalence.
Statistical Test of Hypothesis P-Value 0.40
Comments The p value is not adjusted as this was a planned contrast.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.19
Estimation Comments Effect of tDCS preconditioning on active rTMS: active tDCS preconditioning of active rTMS - sham tDCS preconditioning of active rTMS.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Sham tDCS Preconditioning of Sham rTMS, Active tDCS Preconditioning of Active rTMS
Comments Examines the combined effect of tDCS and rTMS on the P100 amplitude. The effect size for this comparison was .29 (Cohen's).
Type of Statistical Test Equivalence
Comments A p value less than 0.05 is taken as evidence of nonequivalence.
Statistical Test of Hypothesis P-Value .086
Comments The p value was not adjusted for this planned contrast.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.48
Estimation Comments Active tDCS and Active rTMS - Sham tDCS and Sham rTMS.
Time Frame Three lab visits over 6 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cumulative Report of Adverse Events
Hide Arm/Group Description Adverse events data were collected irrespective of Arm/Group assignment. Adverse events were coded as either serious/nonserious, expected/unexpected, and related or unrelated to the intervention. There was only 1 adverse event (a mild headache, which was nonserious, expected and related to active rTMS).
All-Cause Mortality
Cumulative Report of Adverse Events
Affected / at Risk (%)
Total   0/10 (0.00%)    
Hide Serious Adverse Events
Cumulative Report of Adverse Events
Affected / at Risk (%) # Events
Total   0/10 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cumulative Report of Adverse Events
Affected / at Risk (%) # Events
Total   1/10 (10.00%)    
Skin and subcutaneous tissue disorders   
Headache  [1]  1/10 (10.00%)  1
Indicates events were collected by systematic assessment
[1]
Mild headache reported after TMS stimulation.
Our pilot study funding ended. Subjects could not be recruited for the 10 Hz rTMS arm. A proposed study of tinnitus patients could not be initiated. Data analysis could only be completed for one arm.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Mark Mennemeier
Organization: University of Arkansas for Medical Sciences
Phone: 205 410 2413
EMail: msmennemeier@uams.edu
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03309696    
Other Study ID Numbers: 206326
First Submitted: October 9, 2017
First Posted: October 13, 2017
Results First Submitted: October 1, 2020
Results First Posted: November 6, 2020
Last Update Posted: November 17, 2020