Trial Outcomes & Findings for Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury (NCT NCT02623218)

Last Updated: 2020-01-28

Results Overview

Cerebral blood flow velocity was assessed at baseline, post-fight, and post-acupuncture in the TBI-ACUP arm. Cerebral blood flow velocity was assessed at baseline, post fight, and post-sham acupuncture in the TBI-SHAM arm. Cerebral blood flow velocity was assessed at baseline, post exercise, and post-acupuncture in the C-EX arm. Cerebral blood flow velocity was assessed at baseline, and post-acupuncture in the C-ACUP arm. Cerebral blood flow velocity was assessed at baseline, and post-sham acupuncture in the C-SHAM arm.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

At baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline)

Results posted on

2020-01-28

Participant Flow

One enrolled participant did not meet eligibility criteria.

Participant milestones

Participant milestones
Measure	TBI-ACUP This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.	TBI-SHAM This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin.	C-ACUP This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.	C-SHAM This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group. Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin.	C-EX This group of participants without TBI will receive one acupuncture treatment following 30-60 minutes of aerobic exercise, and serve as a healthy control group. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.
Overall Study STARTED	5	4	4	4	4
Overall Study COMPLETED	5	3	4	4	4
Overall Study NOT COMPLETED	0	1	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	TBI-ACUP This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.	TBI-SHAM This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin.	C-ACUP This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.	C-SHAM This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group. Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin.	C-EX This group of participants without TBI will receive one acupuncture treatment following 30-60 minutes of aerobic exercise, and serve as a healthy control group. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.
Overall Study Lost to Follow-up	0	1	0	0	0

Baseline Characteristics

Translational Research Examining Acupuncture Treatment in Traumatic Brain Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TBI-ACUP n=5 Participants This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.	TBI-SHAM n=4 Participants This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin.	C-ACUP n=4 Participants This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.	C-SHAM n=4 Participants This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group. Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin.	C-EX n=4 Participants This group of participants without TBI will receive one acupuncture treatment following 30-60 minutes of aerobic exercise, and serve as a healthy control group. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.	Total n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	21 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	21 Participants n=10 Participants
Region of Enrollment United States	5 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	4 participants n=4 Participants	4 participants n=21 Participants	21 participants n=10 Participants

PRIMARY outcome

Timeframe: At baseline, post-fight, post-exercise (up to 5 hours from baseline), post acupuncture/post sham acupuncture (within 3 hours from baseline)

Population: 1 participant in the TBI-SHAM group did not complete the study

Outcome measures

Outcome measures
Measure	TBI-ACUP n=5 Participants This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.	TBI-SHAM n=4 Participants This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin.	C-ACUP n=4 Participants This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.	C-SHAM n=4 Participants This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group. Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin.	C-EX n=4 Participants This group of participants without TBI will receive one acupuncture treatment following 30-60 minutes of aerobic exercise, and serve as a healthy control group. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in baseline to post-acup/sham in R MCA	5.0 ml/sec Standard Deviation 2.7	9.7 ml/sec Standard Deviation 11.6	7.0 ml/sec Standard Deviation 8.7	5.0 ml/sec Standard Deviation 10.2	-1.5 ml/sec Standard Deviation 2.3
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in post-fight to post-acup/sham in R MCA	1.0 ml/sec Standard Deviation 6.0	-3.0 ml/sec Standard Deviation 4.1	—	—	—
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in baseline to post-fight L MCA	3.2 ml/sec Standard Deviation 4.8	6.7 ml/sec Standard Deviation 10.5	—	—	—
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in baseline to post-fight in R MCA	4 ml/sec Standard Deviation 6.0	12.7 ml/sec Standard Deviation 8.4	—	—	—
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in baseline to post-fight in L ICA	-0.4 ml/sec Standard Deviation 6.8	3 ml/sec Standard Deviation 1.6	—	—	—
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in baseline to post-fight in R ICA	2.4 ml/sec Standard Deviation 3.1	2.3 ml/sec Standard Deviation 2.6	—	—	—
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in baseline to post-fight in BA	2.0 ml/sec Standard Deviation 4.9	4 ml/sec Standard Deviation 3.7	—	—	—
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in post-fight to post-acup/sham in L MCA	-5.6 ml/sec Standard Deviation 5.1	-9.0 ml/sec Standard Deviation 2.2	—	—	—
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in post-fight to post-acup/sham in L ICA	-0.6 ml/sec Standard Deviation 2.2	-7.3 ml/sec Standard Deviation 1.2	—	—	—
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in post-fight to post-acup/sham in R ICA	-3.0 ml/sec Standard Deviation 5.7	-4.7 ml/sec Standard Deviation 3.8	—	—	—
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in post-fight to post-acup/sham in BA	2.0 ml/sec Standard Deviation 3.3	-1.0 ml/sec Standard Deviation 5.0	—	—	—
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in baseline to post-acup/sham in L MCA	-2.0 ml/sec Standard Deviation 7.3	-2.7 ml/sec Standard Deviation 9.0	7.3 ml/sec Standard Deviation 11.1	-2.8 ml/sec Standard Deviation 4.4	-5.8 ml/sec Standard Deviation 7.2
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in baseline to post-acup/sham in L ICA	-1.4 ml/sec Standard Deviation 6.9	-4.0 ml/sec Standard Deviation 2.2	-2.3 ml/sec Standard Deviation 3.1	0.0 ml/sec Standard Deviation 1.9	-2.8 ml/sec Standard Deviation 4.0
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in baseline to post-acup/sham in R ICA	-0.6 ml/sec Standard Deviation 5.0	-2.3 ml/sec Standard Deviation 1.2	-1.5 ml/sec Standard Deviation 7.3	-3.0 ml/sec Standard Deviation 8.1	-1.0 ml/sec Standard Deviation 1.6
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in baseline to post-acup/sham in BA	4.0 ml/sec Standard Deviation 2.1	1.0 ml/sec Standard Deviation 4.3	6.5 ml/sec Standard Deviation 3.4	0.0 ml/sec Standard Deviation 7.9	2.3 ml/sec Standard Deviation 2.7
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in post-exercise to post acup/sham in L MCA	—	—	—	—	-3.5 ml/sec Standard Deviation 1.7
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in post-exercise to post acup/sham in R MCA	—	—	—	—	1.0 ml/sec Standard Deviation 5.9
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in post-exercise to post acup/sham in L ICA	—	—	—	—	-2.3 ml/sec Standard Deviation 4.3
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in post-exercise to post acup/sham in R ICA	—	—	—	—	-1.5 ml/sec Standard Deviation 5.7
Cerebral Blood Flow Velocity in the Left (L) and Right (R) Middle Cerebral Artery (MCA), Internal Carotid Artery (ICA), and Basilar Artery (BA). Change in post-exercise to post acup/sham in BA	—	—	—	—	-0.5 ml/sec Standard Deviation 3.8

SECONDARY outcome

Timeframe: At baseline, post-fight, post-exercise, and post-acupuncture/sham acupuncture

Population: 1 participant in the TBI-SHAM group did not complete the study. Data were not collected for the "Post-Exercise Total Recall Raw" assessment for all groups, and not for "Post Acupuncture/sham Total Recall Raw" assessment in the "CACUP", "C-SHAM" and "C-EX" Arms/Groups.

The Hopkins Verbal Learning Test consists of a 12-item word list, composed of four words from each of three semantic categories which the patient must learn over three trials. For each trial, the subject is instructed to listen carefully as the examiner reads the word list and attempt to memorize the words. The score for total recall is the sum of all the correctly-recalled words from each trial, ranging from 0 to 36, with higher scores indicating better recall and retention.

Outcome measures

Outcome measures
Measure	TBI-ACUP n=5 Participants This group will receive the standard of care plus acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.	TBI-SHAM n=3 Participants This group will receive the standard of care plus sham acupuncture treatments during the acute 10-day phase following a diagnosed TBI. Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin.	C-ACUP n=4 Participants This group of participants without TBI will receive one acupuncture treatment and serve as a healthy control group. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.	C-SHAM n=4 Participants This group of participants will receive one sham acupuncture treatment and serve as a healthy sham comparator group. Sham Acupuncture: Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin.	C-EX n=4 Participants This group of participants without TBI will receive one acupuncture treatment following 30-60 minutes of aerobic exercise, and serve as a healthy control group. Acupuncture: An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.
Changes in Hopkins Verbal Learning Test Baseline Total Recall Raw	20.6 Units on a scale Standard Deviation 2.33	25.7 Units on a scale Standard Deviation 2.87	25.7 Units on a scale Standard Deviation 1.70	28.5 Units on a scale Standard Deviation 3.5	29 Units on a scale Standard Deviation 3.54
Changes in Hopkins Verbal Learning Test Post Acupuncture/sham Total Recall Raw	27 Units on a scale Standard Deviation 1.26	27.7 Units on a scale Standard Deviation 1.25	—	—	—

SECONDARY outcome

Timeframe: Post-fight, Post-Acupuncture/Sham - TBI-ACUP and TBI-SHAM groups only

Population: The groups with zero did not take this post-concussion survey because those participants were healthy controls who did not have a concussion.

The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity").